Child Characteristics, Neuromarkers, and Intervention Components Impacting Treatment Outcome: CCT, TF-CBT, TAU

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02926677
• Collaborator: Stanford Youth Solutions (Other), Drexel University (Other), Iowa State University (Other), University of California, San Francisco (Other)
• Enrollment: 73
• Locations: 2
• Arms: 3
• Actual Duration (Months): 39.7
• Patients Per Site: 36.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This study is designed to examine three treatment conditions for traumatized youth:

Cue-Centered Treatment (CCT), Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT), and Treatment as Usual (TAU) to determine which treatment works most effectively for which youth. The investigators would like to determine feasibility of training on the treatment interventions. In addition, this study aims to inform development of systems of care for chronically traumatized youth.

The investigators hope to determine whether 1) TF-CBT and CCT will have better outcomes than TAU, 2) Child characteristics predict better outcome in either TF-CBT or CCT and to identify which phases of treatment are most effective, and 3) Imaging findings will be predictors of improved outcome. This research is important because while there are many existing trauma interventions for youth, little is known about what is most essential in those interventions. This study will shed light on what components of treatment are most effective. Furthermore, there are minimal guidelines on how to select the most appropriate intervention for a particular child. This study will contribute to that knowledge by informing which interventions are suited best for which youth.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic	Behavioral: Cue-Centered Treatment (CCT); Behavioral: Trauma-Focused CBT (TF-CBT); Behavioral: Treatment as Usual; Device: NIRScout	N/A

Detailed Description

The children will be referred from Stanford Youth Solutions and University of California, San Francisco. Caregivers will undergo a telephone screening according to the inclusion and exclusion criteria. Written consent for participation will be obtained from participants, parents and/or legal guardians. Participants will be randomly assigned to one of three treatment conditions: TF-CBT, CCT, or TAU. Assessments will be administered at 4 time points:

1. pre-treatment, 2) mid-therapy, 3) post-treatment, and 4) three month follow-up. A medical/developmental history form will be completed only pre-treatment. The UCLA PTSD Reaction Index (PTSD-RI) parent and child versions will be used to assess exposure to traumatic events and post-traumatic stress symptoms. Given that trauma has high comorbidity with depression and anxiety disorders these symptoms will be assessed using the Multidimensional Anxiety Scale for Children (MASC) and Children's Depression Inventory (CDI). Executive functioning will be assessed by both child and parent report using the Behavioral Rating Inventory of Executive Function (BRIEF).

In addition, functional near-infrared spectroscopy (fNIRs) will be conducted at each of these time points to assess tasks of working memory, response inhibition, and facial recognition. The investigators will be using the NIRScout which is a portable NIRS recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp, to enable the noninvasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Child Characteristics, Neuromarkers, and Intervention Components Impacting Treatment Outcome: A Randomized Controlled Trial of Cue-Centered Treatment (CCT), Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT), and Treatment as Usual (TAU)
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Apr 24, 2020
• Actual Study Completion Date: Apr 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cue-Centered Therapy (CCT) Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)	Behavioral: Cue-Centered Treatment (CCT); Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.; Device: NIRScout; The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.
Experimental: Trauma-Focused CBT (TF-CBT) Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)	Behavioral: Trauma-Focused CBT (TF-CBT); Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents.; Device: NIRScout; The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.
Experimental: Treatment as Usual (TAU) TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment)	Behavioral: Treatment as Usual; The control group. The standard treatment utilized at Stanford Youth Solutions; Device: NIRScout; The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Child Self-report) [Baseline and month 3 (end of treatment)]

   The UCLA PTSD Reaction Index for DSM 5 is a 31 item self-report measure with child and caregiver versions. The total severity score ranging from 0-80 is obtained by summing the four symptom category sub-scales (criteria B, C, D, & E). A higher score corresponds to greater PTSD severity. The items map onto the DSM 5 criteria for PTSD as well as assessing for dissociative subtype.

2. Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Parent Report) [Baseline and month 3 (end of treatment)]

   The UCLA PTSD Reaction Index for DSM 5 is a 31 item self-report measure with child and caregiver versions. Scores range from 0 to 80 (higher score indicates more sever PTSD symptoms). The items map onto the DSM-V criteria for PTSD as well as assessing for dissociative subtype.

Secondary Outcome Measures

1. Change From Baseline in Children's Depression Inventory (CDI 2) [Baseline and month 3 (end of treatment)]

   The CDI 2 is a 28 item self-report measure that assesses depressive symptoms in the past two weeks. Each item is scored from 0-2 and all items are summed to obtain the total score (total score range: 0-54; a score of 19 or higher is suggestive of clinical depression). The survey contains questions related to negative mood, negative self-esteem, interpersonal problems, anhedonia, and ineffectiveness.

2. Change From Baseline in Multidimensional Anxiety Scale for Children (MASC 2) [Baseline and month 3 (end of treatment)]

   The MASC 2 is a 50 item self-report measure assessing anxiety in the following sub-scales: separation anxiety/phobias, social anxiety, generalized anxiety, OCD, physical symptoms and harm avoidance. The total raw score is obtained by summing all the sub-scales. Total raw scores range from 0-150 with higher scores indicative of more severe anxiety. The raw score gets converted into a T-score interpreted as such: 45-55 average, 56-60 slightly above average, 61-65 above average, 66-70 much above average, and score of 70 or above is considered to be indicative of clinical anxiety.

3. Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report) [Baseline to month 3 (end of treatment)]

   The BRIEF is an 86 item measure that assesses impairment in executive function with symptoms rated on a likert scale of 1 "never", 2 "sometimes" or 3 "often". There are 8 clinical sub-scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor) and two validity scales (Inconsistency and Negativity). A Global Executive Composite score is obtained by summing all 8 clinical sub-scales. The Global Executive Composite ranges from 0-258 with higher scores indicating greater impairment in executive functions. The Global Executive Composite gets converted to a T-score with T-scores of 65 or above considered in the clinical range.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Exposure to at least one traumatic event and endorsement of any trauma symptoms on the UCLA PTSD Reaction Index for DSM-V

2. Ages 7-18

3. Willingness to participate in therapy and fNIRs imaging

4. Caregiver willing to participate in the study

5. Perpetrator of the traumatic event is not living in the home with the child

Exclusion Criteria:

1. Low cognitive functioning (IQ less than 70)

2. Substance dependence as defined by DSM criteria

3. Autism/Schizophrenia

4. Clinically significant medical illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Youth Solutions	Sacramento	California	United States	95826
2	University of California, San Francisco	San Francisco	California	United States	94110

Sponsors and Collaborators

• Stanford University
• Stanford Youth Solutions
• Drexel University
• Iowa State University
• University of California, San Francisco

Investigators

• Principal Investigator: Victor G Carrion, M.D., Stanford University
• Study Director: Hilit Kletter, PhD, Stanford University
• Study Director: Flint Espil, PhD, Stanford Univeristy

Study Documents (Full-Text)

• Informed Consent Form - Jun 11, 2019
• Study Protocol - Sep 18, 2020
• Statistical Analysis Plan - Sep 18, 2020

More Information

Publications

None provided.

• Responsible Party: Victor G. Carrion, Professor-Med CTR LIne, Stanford University
• ClinicalTrials.gov Identifier: NCT02926677
• Other Study ID Numbers: 36092
• First Posted: Oct 6, 2016
• Last Update Posted: Apr 8, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Victor G. Carrion, Professor-Med CTR LIne, Stanford University: PTSD; Child Trauma; Cue-Centered Treatment; Trauma-Focused Cognitive-Behavioral Therapy; fNIRs; CCT; TF-CBT; Posttraumatic stress; NIRX
• Additional relevant MeSH terms: Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Arm/Group Title	Cue-Centered Treatment (CCT)	Trauma-Focused CBT (TF-CBT)	Treatment as Usual (TAU)
Arm/Group Description	Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Trauma-Focused CBT (TF-CBT): Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.
Period Title: Overall Study
STARTED	25	22	26
COMPLETED	8	8	6
NOT COMPLETED	17	14	20

Baseline Characteristics

Arm/Group Title	Cue-Centered Treatment (CCT)	Trauma-Focused CBT (TF-CBT)	Treatment as Usual (TAU)	Total
Arm/Group Description	Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Trauma-Focused CBT (TF-CBT): Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	Total of all reporting groups
Overall Participants	25	22	26	73
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.52 (3.00)	13.41 (3.29)	13.04 (3.05)	12.97 (3.09)
Sex: Female, Male (Count of Participants)
Female	17 68%	13 59.1%	16 61.5%	46 63%
Male	8 32%	9 40.9%	10 38.5%	27 37%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 12%	0 0%	1 3.8%	4 5.5%
Asian	0 0%	0 0%	2 7.7%	2 2.7%
Native Hawaiian or Other Pacific Islander	0 0%	2 9.1%	0 0%	2 2.7%
Black or African American	5 20%	8 36.4%	6 23.1%	19 26%
White	15 60%	11 50%	15 57.7%	41 56.2%
More than one race	1 4%	0 0%	1 3.8%	2 2.7%
Unknown or Not Reported	1 4%	1 4.5%	1 3.8%	3 4.1%
Region of Enrollment (participants) [Number]
United States	25 100%	22 100%	26 100%	73 100%
UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (child self-report) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	35.28 (15.66)	37.10 (15.53)	38.08 (14.04)	36.80 (14.90)
UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (parent report) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	31.13 (16.01)	32.55 (13.73)	33.92 (15.61)	32.55 (15.02)
Multidimensional Anxiety Scale for Children (MASC 2) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	63.76 (21.32)	58.70 (24.25)	59.56 (23.57)	60.64 (22.84)
Children's Depression Inventory (CDI 2) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	17.38 (10.02)	18.29 (9.93)	17.42 (8.85)	17.68 (9.42)
Behavior Rating Inventory of Executive Function (parent report) (BRIEF) (units on a scale) [Mean (Standard Deviation) ]
Inhibit subscale	18.35 (5.71)	18.27 (5.95)	17.75 (4.99)	18.12 (5.47)
Shift subscale	15.87 (3.89)	15.64 (3.33)	15.87 (3.14)	15.80 (3.42)
Emotional Control subscale	21.26 (4.18)	21.45 (5.41)	20.50 (4.87)	21.06 (4.78)
Initiate subscale	15.65 (4.40)	16.77 (2.65)	16.79 (3.97)	16.41 (3.75)
Working Memory subscale	20.39 (5.32)	20.59 (5.00)	20.79 (4.95)	20.59 (5.02)
Plan/Organize subscale	22.65 (5.97)	25.23 (5.41)	23.96 (6.64)	23.93 (6.05)
Organization of Materials subscale	12.83 (3.77)	14.73 (2.75)	13.42 (3.65)	13.64 (3.47)
Monitor subscale	15.61 (3.96)	16.32 (4.22)	16.08 (3.69)	16.00 (3.91)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Child Self-report)
Description	The UCLA PTSD Reaction Index for DSM 5 is a 31 item self-report measure with child and caregiver versions. The total severity score ranging from 0-80 is obtained by summing the four symptom category sub-scales (criteria B, C, D, & E). A higher score corresponds to greater PTSD severity. The items map onto the DSM 5 criteria for PTSD as well as assessing for dissociative subtype.
Time Frame	Baseline and month 3 (end of treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cue-Centered Treatment (CCT)	Trauma-Focused CBT (TF-CBT)	Treatment as Usual (TAU)
Arm/Group Description	Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Trauma-Focused CBT (TF-CBT): Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.
Measure Participants	8	8	6
Mean (Standard Deviation) [score on a scale]	-13.3 (12.1)	-17.8 (15.8)	-9.8 (10.2)

2. Primary Outcome

Title	Change From Baseline in UCLA Posttraumatic Stress Disorder (PTSD) Reaction Index for DSM 5 (Parent Report)
Description	The UCLA PTSD Reaction Index for DSM 5 is a 31 item self-report measure with child and caregiver versions. Scores range from 0 to 80 (higher score indicates more sever PTSD symptoms). The items map onto the DSM-V criteria for PTSD as well as assessing for dissociative subtype.
Time Frame	Baseline and month 3 (end of treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cue-Centered Treatment (CCT)	Trauma-Focused CBT (TF-CBT)	Treatment as Usual (TAU)
Arm/Group Description	Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Trauma-Focused CBT (TF-CBT): Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.
Measure Participants	8	8	6
Mean (Standard Deviation) [score on a scale]	-11.2 (11.1)	-17.4 (16.1)	-2.3 (10.2)

3. Secondary Outcome

Title	Change From Baseline in Children's Depression Inventory (CDI 2)
Description	The CDI 2 is a 28 item self-report measure that assesses depressive symptoms in the past two weeks. Each item is scored from 0-2 and all items are summed to obtain the total score (total score range: 0-54; a score of 19 or higher is suggestive of clinical depression). The survey contains questions related to negative mood, negative self-esteem, interpersonal problems, anhedonia, and ineffectiveness.
Time Frame	Baseline and month 3 (end of treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cue-Centered Treatment (CCT)	Trauma-Focused CBT (TF-CBT)	Treatment as Usual (TAU)
Arm/Group Description	Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Trauma-Focused CBT (TF-CBT): Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.
Measure Participants	8	8	6
Mean (Standard Deviation) [score on a scale]	-3.6 (7.3)	-4.7 (7.1)	-6.0 (9.6)

4. Secondary Outcome

Title	Change From Baseline in Multidimensional Anxiety Scale for Children (MASC 2)
Description	The MASC 2 is a 50 item self-report measure assessing anxiety in the following sub-scales: separation anxiety/phobias, social anxiety, generalized anxiety, OCD, physical symptoms and harm avoidance. The total raw score is obtained by summing all the sub-scales. Total raw scores range from 0-150 with higher scores indicative of more severe anxiety. The raw score gets converted into a T-score interpreted as such: 45-55 average, 56-60 slightly above average, 61-65 above average, 66-70 much above average, and score of 70 or above is considered to be indicative of clinical anxiety.
Time Frame	Baseline and month 3 (end of treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cue-Centered Treatment (CCT)	Trauma-Focused CBT (TF-CBT)	Treatment as Usual (TAU)
Arm/Group Description	Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Trauma-Focused CBT (TF-CBT): Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.
Measure Participants	8	8	6
Mean (Standard Deviation) [score on a scale]	-15.8 (20.5)	-12.8 (11.2)	-16.8 (28.7)

5. Secondary Outcome

Title	Change From Baseline in the Behavior Rating Inventory of Executive Function (BRIEF) (Parent Report)
Description	The BRIEF is an 86 item measure that assesses impairment in executive function with symptoms rated on a likert scale of 1 "never", 2 "sometimes" or 3 "often". There are 8 clinical sub-scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials, Monitor) and two validity scales (Inconsistency and Negativity). A Global Executive Composite score is obtained by summing all 8 clinical sub-scales. The Global Executive Composite ranges from 0-258 with higher scores indicating greater impairment in executive functions. The Global Executive Composite gets converted to a T-score with T-scores of 65 or above considered in the clinical range.
Time Frame	Baseline to month 3 (end of treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cue-Centered Therapy (CCT)	Trauma-Focused CBT (TF-CBT)	Treatment as Usual (TAU)
Arm/Group Description	Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Trauma-Focused CBT (TF-CBT): Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.	TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.
Measure Participants	8	8	6
Inhibit subscale	2.22 (1.72)	0.44 (4.25)	-2.00 (5.73)
Shift subscale	0.56 (1.67)	2.33 (2.24)	-0.83 (4.36)
Emotional Control subscale	2.56 (3.28)	3.89 (2.85)	0.17 (4.12)
Initiate subscale	1.11 (3.14)	1.11 (2.71)	1.17 (2.64)
Working memory subscale	2.67 (2.29)	2.00 (3.35)	-0.33 (4.23)
Plan/Organize subscale	1.78 (3.03)	2.22 (5.45)	-0.67 (4.59)
Organization of Materials subscale	1.00 (3.12)	1.44 (1.74)	1.00 (2.00)
Monitor subscale	0.78 (2.44)	0.44 (3.32)	-2.17 (5.46)

Adverse Events

Time Frame	Up to 4 1/2 months
Arm/Group Title	Cue-Centered Treatment (CCT)		Trauma-Focused CBT (TF-CBT)		Treatment as Usual (TAU)
Arm/Group Description	Cue-Centered Therapy provides 15 sessions of treatment. Focuses on developing skills in recognizing stress cues and coping skills. Taught to self-soothe without the active involvement of a guardian. Teaches emotional, cognitive, and physiological conditioning to deal with ongoing traumatic stress. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Cue-Centered Treatment (CCT): Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.		Trauma-Focused CBT provides 15 sessions of treatment. Focuses on reframing subconscious thought and emotions with emotional and cognitive conditioning. Uses the active involvement and support of guardians. Addresses discrete traumatic incidents in the past. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Trauma-Focused CBT (TF-CBT): Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents. NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.		TAU is the current Standard treatment at Stanford Youth Solutions will serve as the control. The treatment is known as flexible integrated services. Will have a fNIR (NIRScout) scan at 4 time points throughout study (baseline, midpoint, end of treatment, and 3 month post-treatment) Treatment as Usual: The control group. The standard treatment utilized at Stanford Youth Solutions NIRScout: The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.
All Cause Mortality
	Cue-Centered Treatment (CCT)		Trauma-Focused CBT (TF-CBT)		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/22 (0%)		0/26 (0%)
Serious Adverse Events
	Cue-Centered Treatment (CCT)		Trauma-Focused CBT (TF-CBT)		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/22 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Cue-Centered Treatment (CCT)		Trauma-Focused CBT (TF-CBT)		Treatment as Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/22 (0%)		0/26 (0%)

Limitations/Caveats

The study was underpowered because the number of participants with analyzable data did not meet the threshold for the planned analysis.

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.