Stepped Care for Children After Trauma: Optimizing Treatment

• Sponsor: University of South Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT02537678
• Collaborator: (none)
• Enrollment: 183
• Locations: 6
• Arms: 2
• Actual Duration (Months): 59.7
• Patients Per Site: 30.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Children who are exposed to traumatic events are at risk for developing PTSD and other mental health problems. Although effective treatments for childhood PTSD exist, service delivery approaches that are more accessible, efficient, and cost-effective are needed to improve access to evidence-based treatment. The proposed study furthers our pilot work and evaluates an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy designed to optimize treatment in community settings and improve the value and efficiency of trauma-focused treatment for children compared to existing approaches, thereby reducing childhood PTSD and related societal impacts and costs.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Behavioral: Stepped Care TF-CBT; Behavioral: Standard TF-CBT	N/A

Detailed Description

Approximately 68-80% of youth will experience at least one potentially traumatic event during their childhood with about one third experiencing more than one traumatic event. Exposure to traumatic events markedly elevates the risk of developing posttraumatic stress disorder (PTSD) and associated impairment. Despite advances in effective trauma-focused treatments for children, the lack of efficient, accessible, personalized, and cost-effective trauma treatment for children is a major public health concern. Thus, there is a critical need for interventions to improve efficiency, access, and cost-effectiveness and to offer tailored approaches that meet the unique needs of the child. The present study builds on the investigators NIH-funded pilot work (1R34MH092373-01A1) that developed an innovative Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT). The purpose of the proposed study is to examine how to optimize the efficiency (e.g., via matching children to appropriate treatment dosage at baseline, utilizing second-stage tailoring variables, and identifying mechanisms of change) and cost-effectiveness of Stepped Care TF-CBT. The long-term goal is to develop an effective, efficient, accessible, and cost-effective adaptive Stepped Care TF-CBT intervention that can be available to more trauma-exposed children, and to advance knowledge about service delivery approaches that may be applicable to providing treatment for other childhood mental health disorders. The goal of the study is consistent with the strategic objective to "Develop New and Better Interventions that Incorporate the Diverse Needs and Circumstances of People with Mental Illness," and the research priorities that call for trials that foster prescriptive, personalized mental health care, incorporate tailoring variables to match patient interventions, improve access to services, decrease costs of services, and incorporate measures of putative mechanisms of action in trials in "real world" settings. In a randomized clinical trial with 216 children ages 4 to 12 years at community-based agencies, the following aims are proposed:

Aim 1: To examine Stepped Care TF-CBT (e.g., starting with Step One parent-led, therapist-assisted treatment and then either maintenance or Step Two TF-CBT) relative to standard TF-CBT (e.g., therapist-led treatment);

Aim 2: To examine tailoring variables that could be used to individualize (i.e., tailor) the decision of which children should be assigned at baseline to Stepped Care TF-CBT versus standard TF-CBT;

Aim 3: To examine if changes in the potential mechanisms of change variables (e.g., fear arousal, maladaptive cognitions, negative expectancy, and fear toleration) mediate treatment on child PTSD symptoms (PTSS) and impairment;

Aim 4: To examine the economic cost of delivering Stepped Care TF-CBT versus standard TF-CBT. Children with PTSD are at considerable risk for numerous biopsychosocial problems. Without accessible, effective treatment, these problems tend to persist into adulthood. This study will yield clinically important data which will improve the value and efficiency of treatment of children with PTSD, thereby reducing childhood PTSD and related societal impacts and costs.

Study Design

• Study Type: Interventional
• Actual Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Stepped Care for Children After Trauma: Optimizing Treatment
• Actual Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Jul 23, 2020
• Actual Study Completion Date: Jul 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stepped Care TF-CBT Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT.	Behavioral: Stepped Care TF-CBT; Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks
Active Comparator: Standard TF-CBT Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT.	Behavioral: Standard TF-CBT; Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).

Outcome Measures

Primary Outcome Measures

1. Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms [Post treatment]

   Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.

2. Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms [6-month Follow up]

   Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.

3. Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms [12-month follow up]

   Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.

4. Child Sheehan Disability Scale Parent Version [Post treatment]

   The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.

5. Child Sheehan Disability Scale Parent Version [6-month follow up]

   The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.

6. Child Sheehan Disability Scale Parent Version [12-month follow up]

   The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.

Secondary Outcome Measures

1. Child Behavior Checklist Internalizing Symptoms [Post treatment]

   Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms.

2. Child Behavior Checklist Internalizing Symptoms [6-month follow up]

   Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms.

3. Child Behavior Checklist Internalizing Symptoms [12-month follow up]

   Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms.

4. Child Behavior Checklist Externalizing Symptoms [Post treatment]

   Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.

5. Child Behavior Checklist Externalizing Symptoms [6-month follow up]

   Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.

6. Child Behavior Checklist Externalizing Symptoms [12-month follow up]

   Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.

7. Clinical Global Impression-Severity (CGI-S) [Post treatment]

   The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity.

8. Clinical Global Impression-Severity (CGI-S) [6-month assessment]

   The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity.

9. Clinical Global Impression-Severity (CGI-S) [12-month follow up]

   The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity.

10. Clinical Global Impression-Improvement (CGI-I) [Post treatment]

    The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response.

11. Clinical Global Impression-Improvement (CGI-I) [6-month treatment]

    The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response.

12. Clinical Global Impression-Improvement (CGI-I) [12-month follow up]

    The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response.

Other Outcome Measures

1. Parenting Stress Scale (PSS) [Post treatment]

   The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress.

2. Parenting Stress Scale (PSS) [6-month follow up]

   The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress.

3. Parenting Stress Scale (PSS) [12-month follow up]

   The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress.

4. Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale [Post treatment]

   The depression subscale self-report will be used to measure change in parent depression, Scores range from 0 to 42 with higher scores indicating higher depressive symptoms.

5. Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale [6-month follow up]

   The depression subscale self-report will be used to measure change in parent depression, Scores range from 0 to 42 with higher scores indicating higher depressive symptoms.

6. Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale [12-month follow up]

   The depression subscale self-report will be used to measure change in parent depression, Scores range from 0 to 42 with higher scores indicating higher depressive symptoms.

7. The PTSD Checklist-Civilian (PCL-C) [Post treatment]

   The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms.

8. The PTSD Checklist-Civilian (PCL-C) [6-month follow up]

   The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms.

9. The PTSD Checklist-Civilian (PCL-C) [12-month follow up]

   The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Parent/Guardian-child dyads enrolled.

Inclusion Criteria:

1. Child experienced at least one traumatic event after the age of 36 months

2. Child age 4-6 must meet at least four PTSD symptoms and children age 7 to 12 must meet at least five PTSD symptoms with at least one symptom in re-experiencing or one symptom in avoidance

3. At enrollment, the child must be between 4-12 years of age

4. The parent/guardian must be willing and able to participate in the treatment and complete informed consent

Exclusion Criteria:

1. Psychosis, mental retardation, autism spectrum disorder in the child or any condition that would limit the caregiver's ability to understand CBT and the child's ability to follow instructions

2. Parent has had substance use disorder (SUD) within the past 3 months.

3. Child or parent is suicidal

4. Child or parent is not fluent in English

5. Child is currently taking psychotropic medication and is not on a stable medication regimen for at least 4 weeks prior to admission to the study. For stimulants or benzodiazepines, the medication regimen must be stable for 2 weeks. If appropriate, a delayed entry will be allowed so that once a child is on a stable dosage the child may be enrolled in the study.

6. Child is receiving trauma-focused psychotherapy during study treatment.

7. Parent/caregiver who would be treatment participant was the perpetrator, or the child was perpetrated by a person who still lives in the home

8. Child is having unsupervised face-to-face contact with the identified perpetrator

9. Siblings

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Home Society	Jacksonville	Florida	United States	32207
2	Directions for Living	Largo	Florida	United States	33773
3	Pasco Kids First	New Port Richey	Florida	United States	34654
4	USF St. Petersburg Family Study Center	Saint Petersburg	Florida	United States	33701
5	Suncoast Center, Inc	Saint Petersburg	Florida	United States	33733
6	Crisis Center of Tampa Bay	Tampa	Florida	United States	33613

Sponsors and Collaborators

• University of South Florida

Investigators

• Principal Investigator: Alison A Salloum, PhD, University of South Florida

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 11, 2022
• Informed Consent Form: Informed Consent Form Parent - Dec 7, 2019
• Informed Consent Form: Informed Assent Forms for Children - Dec 7, 2019

More Information

Publications

• Salloum A, Scheeringa MS, Cohen JA, Storch EA. Development of Stepped Care Trauma-Focused Cognitive-Behavioral Therapy for Young Children. Cogn Behav Pract. 2014 Feb 1;21(1):97-108.
• Salloum A, Scheeringa MS, Cohen JA, Storch EA. Responder Status Criterion for Stepped Care Trauma-Focused Cognitive Behavioral Therapy for Young Children. Child Youth Care Forum. 2015 Feb;44(1):59-78.

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT02537678
• Other Study ID Numbers: 1R01MH107522-01
• First Posted: Sep 2, 2015
• Last Update Posted: May 6, 2022
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Recruitment Details

Participants were recruited from six community clinics between October 2015 and April 2019 from five community behavioral health nonprofit organizations and one university community-based clinic. The first participant was enrolled 10/6/2015 and the last participant was enrolled 4/19/2019.

Pre-assignment Detail

Parent/guardian-child dyads participated. 212 dyads enrolled. 183 dyads met inclusion and were randomized to treatment. Exclusion before assignment included: Less than 5 trauma symptoms, perpetrator in home, not wanting to participate, no trauma after age 3, cognitive impairment, did not attended assessment, substance abuse within past 3 months, unsupervised visits with perpetrator, medication not stable, no traumatic symptoms, parent suicidal, autism spectrum, parent unable/unwilling.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Period Title: Baseline to Post-treatment
STARTED	91	92
Completed Post-treatment	61	71
COMPLETED	61	71
NOT COMPLETED	30	21
Period Title: Baseline to Post-treatment
STARTED	61	71
COMPLETED	53	64
NOT COMPLETED	8	7
Period Title: Baseline to Post-treatment
STARTED	53	64
COMPLETED	53	63
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Stepped Care Trauma Focused-CBT (TF-CBT)	Standard Trauma Focused-CBT (TF-CBT)	Total
Arm/Group Description	Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. Parent/Guardian-child dyads participated. Stepped Care TF-CBT: Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together), scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks	Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. Parent/Guardian-child dyads participated. Standard TF-CBT: Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).	Total of all reporting groups
Overall Participants	91	92	183
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.32 (2.39)	7.46 (2.45)	7.89 (2.46)
Sex: Female, Male (Count of Participants)
Female	48 52.7%	53 57.6%	101 55.2%
Male	43 47.3%	39 42.4%	82 44.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	26 28.6%	23 25%	49 26.8%
Not Hispanic or Latino	65 71.4%	69 75%	134 73.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 1.1%	1 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	30 33%	27 29.3%	57 31.1%
White	46 50.5%	48 52.2%	94 51.4%
More than one race	15 16.5%	16 17.4%	31 16.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Parent/Guardian Relationship to the child (Count of Participants)
Parent	80 87.9%	88 95.7%	168 91.8%
Relative	11 12.1%	4 4.3%	15 8.2%
Parent /Guardian ethnicity (Count of Participants)
Hispanic or Latino	28 30.8%	14 15.2%	42 23%
Not Hispanic of Latino	63 69.2%	78 84.8%	141 77%
Parent/Guardian race (Count of Participants)
White	54 59.3%	59 64.1%	113 61.7%
Black or African American	36 39.6%	30 32.6%	66 36.1%
American Indian/Alaskan Native	1 1.1%	1 1.1%	2 1.1%
Unknown	0 0%	2 2.2%	2 1.1%
Household income (Count of Participants)
$0 -9,999	15 16.5%	17 18.5%	32 17.5%
$10,000-24,999	13 14.3%	22 23.9%	35 19.1%
$25,000-34,999	13 14.3%	12 13%	25 13.7%
$35,000-49,999	21 23.1%	16 17.4%	37 20.2%
$50,000+	29 31.9%	25 27.2%	54 29.5%
Education levels (Count of Participants)
No high school diploma (9-11yrs)	7 7.7%	7 7.6%	14 7.7%
High school graduate (12 years)	20 22%	16 17.4%	36 19.7%
Some college (13-15 years)	41 45.1%	44 47.8%	85 46.4%
College graduate and above (16+ years)	23 25.3%	25 27.2%	48 26.2%
Parent/Guardian employed (Count of Participants)
Employed	63 69.2%	59 64.1%	122 66.7%
Not employed	28 30.8%	33 35.9%	61 33.3%
Parent/Guardian with posttraumatic stress disorder (Count of Participants)
Parent/guardian met criteria for PTSD	45 49.5%	27 29.3%	72 39.3%
Parent/guardian did not meet criteria for PTSD	46 50.5%	65 70.7%	111 60.7%
Parent/Guardian age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.23 (10.11)	36.52 (9.97)	37.37 (10.05)
Parent/Guardian relationship status (Count of Participants)
Single	34 37.4%	29 31.5%	63 34.4%
Married	25 27.5%	26 28.3%	51 27.9%
Divorced	12 13.2%	14 15.2%	26 14.2%
Separated	12 13.2%	13 14.1%	25 13.7%
Widowed	3 3.3%	4 4.3%	7 3.8%
Other	5 5.5%	6 6.5%	11 6%
Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	50.53 (12.15)	51.34 (13.50)	50.93 (12.81)
Child Sheehan Disability Scale Parent Version (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	20.99 (10.80)	21.29 (12.86)	21.14 (11.85)

Outcome Measures

1. Primary Outcome

Title	Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
Description	Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.
Time Frame	Post treatment

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	36.00 (10.52)	35.57 (9.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments	Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.
Statistical Test of Hypothesis	p-Value	.006
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.43
	Confidence Interval	(1-Sided) 97.5%; -3.26 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.43
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT

2. Primary Outcome

Title	Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
Description	Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.
Time Frame	6-month Follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	36.84 (11.56)	36.31 (9.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments	Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.
Statistical Test of Hypothesis	p-Value	.004
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.53
	Confidence Interval	(1-Sided) 97.5%; -3.47 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.49
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT

3. Primary Outcome

Title	Trauma Symptom Checklist for Young Children Posttraumatic Stress Symptoms
Description	Trauma Symptom Children for Young Children Posttraumatic Stress total score will measure changes in child posttraumatic stress symptoms for children ages 4-12. Score ranges from 27 to 108 with higher scores indicating greater posttraumatic stress symptoms.
Time Frame	12-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	35.05 (8.26)	34.92 (9.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments	Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied 12-month assessment.
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.13
	Confidence Interval	(1-Sided) 97.5%; -2.50 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.20
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

4. Primary Outcome

Title	Child Sheehan Disability Scale Parent Version
Description	The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.
Time Frame	Post treatment

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. Stepped Care TF-CBT: Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks	Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. Standard TF-CBT: Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	12.03 (16.36)	12.82 (13.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments	Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.79
	Confidence Interval	(1-Sided) 97.5%; -2.94 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.89
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

5. Primary Outcome

Title	Child Sheehan Disability Scale Parent Version
Description	The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.
Time Frame	6-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	13.23 (16.23)	11.33 (12.93)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments	Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.
Statistical Test of Hypothesis	p-Value	.044
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.89
	Confidence Interval	(1-Sided) 97.5%; -6.33 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.25
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

6. Primary Outcome

Title	Child Sheehan Disability Scale Parent Version
Description	The Child Sheehan Disability Scale is a caregiver report to measure childhood impairment. The change in the impairment scores will be used to measure change in impairment.Scores range from 0 to 50 with higher scores indicating greater impairment.
Time Frame	12-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	7.88 (12.07)	8.25 (11.38)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments	Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.38
	Confidence Interval	(1-Sided) 97.5%; -3.07 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.75
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

7. Secondary Outcome

Title	Child Behavior Checklist Internalizing Symptoms
Description	Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms.
Time Frame	Post treatment

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. Stepped Care TF-CBT: Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks	Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. Standard TF-CBT: Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	45.68 (10.42)	44.62 (10.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.
Statistical Test of Hypothesis	p-Value	0.016
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.06
	Confidence Interval	(1-Sided) 97.5%; -4.06 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.52
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

8. Secondary Outcome

Title	Child Behavior Checklist Internalizing Symptoms
Description	Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms.
Time Frame	6-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	47.17 (12.33)	46.93 (12.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments	Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.23
	Confidence Interval	(1-Sided) 97.5%; -3.72 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.77
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

9. Secondary Outcome

Title	Child Behavior Checklist Internalizing Symptoms
Description	Changes in T scores in internalizing symptoms. T scores may range from 33 to 100 with higher T scores indicating greater internalizing symptoms.
Time Frame	12-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	45.71 (12.46)	45.56 (12.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.16
	Confidence Interval	(1-Sided) 97.5%; -3.89 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.89
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

10. Secondary Outcome

Title	Child Behavior Checklist Externalizing Symptoms
Description	Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.
Time Frame	Post treatment

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. Stepped Care TF-CBT: Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks	Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. Standard TF-CBT: Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	47.41 (12.00)	46.40 (11.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.01
	Confidence Interval	(1-Sided) 97.5%; -4.24 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.64
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

11. Secondary Outcome

Title	Child Behavior Checklist Externalizing Symptoms
Description	Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.
Time Frame	6-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	49.76 (12.52)	48.40 (12.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.
Statistical Test of Hypothesis	p-Value	0.015
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.36
	Confidence Interval	(1-Sided) 97.5%; -4.88 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.78
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

12. Secondary Outcome

Title	Child Behavior Checklist Externalizing Symptoms
Description	Changes in T scores in externalizing symptoms. T scores range from 33 to 100 with higher T scores indicating greater externalizing problems.
Time Frame	12-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	46.92 (14.82)	45.17 (12.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.
Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.75
	Confidence Interval	(1-Sided) 97.5%; -5.68 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.99
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

13. Secondary Outcome

Title	Clinical Global Impression-Severity (CGI-S)
Description	The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity.
Time Frame	Post treatment

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. Stepped Care TF-CBT: Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks	Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. Standard TF-CBT: Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	1.66 (1.46)	1.66 (1.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(1-Sided) 97.5%; -0.39 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.20
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

14. Secondary Outcome

Title	Clinical Global Impression-Severity (CGI-S)
Description	The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity.
Time Frame	6-month assessment

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	1.45 (1.47)	1.41 (1.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.04
	Confidence Interval	(1-Sided) 97.5%; -0.47 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.22
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

15. Secondary Outcome

Title	Clinical Global Impression-Severity (CGI-S)
Description	The CGI-S is a widely used 7-point rating of severity of psychopathology including. impairment (0=no illness, 6=extremely severe). Changes in ratings will be used to measure change in severity.
Time Frame	12-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	1.09 (1.31)	1.13 (1.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	(1-Sided) 97.5%; -0.30 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

16. Secondary Outcome

Title	Clinical Global Impression-Improvement (CGI-I)
Description	The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response.
Time Frame	Post treatment

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. Stepped Care TF-CBT: Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks	Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. Standard TF-CBT: Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	2.17 (1.08)	2.15 (0.98)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.02
	Confidence Interval	(1-Sided) 97.5%; -0.29 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.14
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

17. Secondary Outcome

Title	Clinical Global Impression-Improvement (CGI-I)
Description	The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response.
Time Frame	6-month treatment

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	2.16 (1.09)	2.09 (1.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.07
	Confidence Interval	(1-Sided) 97.5%; -0.38 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.16
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

18. Secondary Outcome

Title	Clinical Global Impression-Improvement (CGI-I)
Description	The CGI-I modified version, 8-point rating will be used for treatment response. A 1, 2 or 3 will be used to indicate treatment response.
Time Frame	12-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	1.74 (0.83)	1.78 (0.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.04
	Confidence Interval	(1-Sided) 97.5%; -0.19 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.12
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

19. Other Pre-specified Outcome

Title	Parenting Stress Scale (PSS)
Description	The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress.
Time Frame	Post treatment

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. Stepped Care TF-CBT: Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks	Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. Standard TF-CBT: Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	32.46 (10.67)	32.03 (9.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.43
	Confidence Interval	(1-Sided) 97.5%; -3.33 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.47
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

20. Other Pre-specified Outcome

Title	Parenting Stress Scale (PSS)
Description	The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress.
Time Frame	6-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	33.77 (13.42)	32.30 (10.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.
Statistical Test of Hypothesis	p-Value	0.028
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.47
	Confidence Interval	(1-Sided) 97.5%; -4.99 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.78
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

21. Other Pre-specified Outcome

Title	Parenting Stress Scale (PSS)
Description	The PSS scores will be used to measure change in parenting stress. Scores range from 18 to 90 with higher scores indicating higher parenting stress.
Time Frame	12-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	32.26 (11.20)	31.82 (10.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.44
	Confidence Interval	(1-Sided) 97.5%; -3.64 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.62
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

22. Other Pre-specified Outcome

Title	Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale
Description	The depression subscale self-report will be used to measure change in parent depression, Scores range from 0 to 42 with higher scores indicating higher depressive symptoms.
Time Frame	Post treatment

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. Stepped Care TF-CBT: Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks	Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. Standard TF-CBT: Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	5.06 (6.97)	4.00 (5.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.05
	Confidence Interval	(1-Sided) 97.5%; -2.82 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.90
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

23. Other Pre-specified Outcome

Title	Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale
Description	The depression subscale self-report will be used to measure change in parent depression, Scores range from 0 to 42 with higher scores indicating higher depressive symptoms.
Time Frame	6-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	4.64 (6.69)	4.07 (6.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.57
	Confidence Interval	(1-Sided) 97.5%; -2.31 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.88
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

24. Other Pre-specified Outcome

Title	Depression, Anxiety and Stress Scale (Short Form)- Depression Subscale
Description	The depression subscale self-report will be used to measure change in parent depression, Scores range from 0 to 42 with higher scores indicating higher depressive symptoms.
Time Frame	12-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT; all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	4.18 (5.66)	4.39 (5.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	0.21
	Confidence Interval	(1-Sided) 97.5%; -1.43 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.83
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

25. Other Pre-specified Outcome

Title	The PTSD Checklist-Civilian (PCL-C)
Description	The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms.
Time Frame	Post treatment

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Stepped Care TF-CBT consist of two steps. Step One is a parent-led therapist-assisted treatment and Step Two is standard TF-CBT. Stepped Care TF-CBT: Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks	Standard TF-CBT consist of therapist-directly weekly in-office therapy based on the trauma-focused components of TF-CBT. Standard TF-CBT: Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	13.40 (15.82)	12.63 (15.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults. Non-inferiority analysis with alpha 2.5% was applied at post assessment.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.77
	Confidence Interval	(1-Sided) 97.5%; -5.04 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.16
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

26. Other Pre-specified Outcome

Title	The PTSD Checklist-Civilian (PCL-C)
Description	The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms.
Time Frame	6-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	14.67 (17.78)	12.27 (14.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.40
	Confidence Interval	(1-Sided) 97.5%; -6.87 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.27
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

27. Other Pre-specified Outcome

Title	The PTSD Checklist-Civilian (PCL-C)
Description	The PCL-C will be used to measure change in parent self-report of PTSD symptom severity. Scores range from 0 to 80 with higher scores indicating greater posttraumatic stress symptoms.
Time Frame	12-month follow up

Outcome Measure Data

Analysis Population Description

Intent to treat population (ITT: all participants assigned to stepped care TF-CBT and standard TF-CBT). Multiple imputation was applied for ITT analysis, with ten imputations generated at item level and individual level.

Arm/Group Title	Stepped Care TF-CBT	Standard TF-CBT
Arm/Group Description	Participants (parent-child dyads) received Step One which is a parent-led therapist assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided	Participants (parent-child dyads) received therapist led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
Measure Participants	91	92
Mean (Standard Deviation) [score on a scale]	13.51 (15.25)	11.78 (13.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care TF-CBT, Standard TF-CBT
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults.Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 1 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.74
	Confidence Interval	(1-Sided) 97.5%; -5.80 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.06
	Estimation Comments
Other Statistical Analysis		Treatment difference = standard TF-CBT - stepped care TF-CBT

Adverse Events

Time Frame	From enrollment to the end of the the 12 month post treatment follow-up assessment (approximately 1 year, 4 months). Assessed every visit from enrollment to the end of the 12 month post treatment follow up assessment.
Arm/Group Title	Stepped Care TF-CBT		Standard TF-CBT
Arm/Group Description	Participants (parents/guardian and children) received Step One which is a parent-led therapist-assisted treatment: 3 therapist-led sessions along with 11 parent-child meetings using a parent-child workbook. Children who do not meet responder status will receive Step Two: 9 therapist-directed sessions of TF-CBT. Two as needed sessions could be provided.		Participants (parents/guardians and children) received therapist-led trauma-focused cognitive behavioral therapy (TF-CBT). Two as needed sessions could be provided.
All Cause Mortality
	Stepped Care TF-CBT		Standard TF-CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/182 (0%)		0/184 (0%)
Serious Adverse Events
	Stepped Care TF-CBT		Standard TF-CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/182 (10.4%)		29/184 (15.8%)
Cardiac disorders
Heart surgery due to chronic condition (children)	0/182 (0%)	0	1/184 (0.5%)	1
Gastrointestinal disorders
Hospitalized due to gastrointestinal issues (children)	1/182 (0.5%)	1	0/184 (0%)	0
General disorders
Hospitalized due to prior condition (parents/guardians)	0/182 (0%)	0	4/184 (2.2%)	4
Infections and infestations
Hospitalized due to virus (children)	1/182 (0.5%)	1	0/184 (0%)	0
Hospitalized due to meningitis (parents/guardians)	0/182 (0%)	0	1/184 (0.5%)	1
Psychiatric disorders
Hospitalized due to psychiatric crisis and for evaluation (children)	2/182 (1.1%)	2	2/184 (1.1%)	7
Suicidal ideation (children)	3/182 (1.6%)	3	6/184 (3.3%)	7
Social circumstances
Child abuse report (children)	12/182 (6.6%)	16	15/184 (8.2%)	19
Other (Not Including Serious) Adverse Events
	Stepped Care TF-CBT		Standard TF-CBT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/182 (4.9%)		16/184 (8.7%)
Psychiatric disorders
Worsening of posttraumatic stress symptoms (children)	9/182 (4.9%)	10	16/184 (8.7%)	26

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.