Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

• Sponsor: Children's Hospital of Philadelphia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00451282
• Collaborator: Centers for Disease Control and Prevention (U.S. Fed)
• Enrollment: 290
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 11.1

Study Details

Study Description

Brief Summary

This study will evaluate the impact of a brief psychosocial intervention delivered to children or adolescents who are hospitalized for an unintentional injury. The intervention is designed to promote psychological recovery and enhance functional outcomes after injury. The study will also provide preliminary data concerning cost-effectiveness of the intervention.

The core study hypotheses are that children receiving the intervention will (1) have lower severity of post-traumatic stress disorder (PTSD) and depression symptoms at follow-up; (2) show greater adherence to discharge instructions and better health-related quality of life at follow-up, and (3) have higher rates of attendance at scheduled follow-up appointments and lower rates of emergency room utilization and re-hospitalization in the 6 months post-injury, compared to those receiving usual care.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Posttraumatic	Behavioral: stepped preventive care	Phase 3

Detailed Description

The purpose of this study is to examine the effectiveness of a stepped care model for prevention of psychosocial distress (especially posttraumatic stress) after injury. The model includes screening for risk, standard follow-up with those at risk, and additional evidence-based interventions matched to individual need.

The study will evaluate the impact of the intervention on psychosocial outcomes (PTSD and depression symptoms); as well as health outcomes (adherence to discharge instructions, health-related quality of life), and will provide preliminary data to inform cost-effectiveness analyses by describing the costs of providing the intervention and examining its impact on subsequent health service utilization.

Study Design: 180 children at risk for persistent psychosocial distress post-injury, based on a screening assessment, will be randomized to the Stepped Preventive Care intervention or usual care. An additional comparison group of 90 low risk children will also receive usual care and be followed for assessment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 290 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stepped Preventive Care Receiving Stepped Preventive Care intervention - at least 2 brief assessments with nurse and/or social worker (1) during hospital admission , and (2) approximately 2 weeks post-discharge. Additional interventions provided as needed, based on manual.	Behavioral: stepped preventive care; 2 targeted assessments (T1: in hospital within a few days of injury; T2: two weeks post-discharge) are administered by nurse or social worker, and determine need for additional assistance modules. Additional modules include case management, care coordination, assistance with child and family coping with injury/distress, and trauma-focused Cognitive Behavior Therapy (CBT) beginning at 4-6 weeks post-injury if needed.
No Intervention: Treatment as usual Medical and psychosocial care per usual hospital protocols, which may include social work support.

Outcome Measures

Primary Outcome Measures

1. PTSD Symptoms in Children 6 Weeks Post-injury [6 weeks]

   The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.

2. PTSD Symptoms in Children 6 Months Post-injury [6 months]

   The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to DSM-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.

Secondary Outcome Measures

1. Depression Symptoms in Children 6 Wks Post-injury [6 weeks]

   The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.

2. Depression Symptoms in Children 6 Mos Post-injury [6 months]

   The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.

3. Health-related Quality of Life 6 Weeks and 6 Months Post-injury [6 months]

   The Pediatric Quality of Life Inventory is a well-validated measure of child health-related quality of life. Children completed the measure at baseline to report preinjury functioning and at 6-weeks and 6-months postinjury regarding current functioning. Current analyses utilize the 8-item Physical health/Physical functioning subscale. Scores range from 0-100; higher scores indicate better functioning outcomes.

4. Adherence With Medical Discharge Instructions [6 months]

   The Health Care Questionnaire for Parents, created for this study, will assess health services utilized post-injury, adherence with specific discharge instructions (e.g., attendance at recommended follow-up appointments), as well as the number of days missed from work (parent) or school (child) related to the injury. Outcome variables to assess adherence will be dichotomized (e.g., attended scheduled appt? yes / no). The Health Care Questionnaire for Primary Care Physicians (PCPs) will assess primary care providers' contacts with study participants, including whether psychosocial concerns were identified since the injury.

5. Health Service Utilization Over the 6 Months Post-injury [6 months]

   Medical records were used as the primary source of service utilization data; parent report supplemented this information if records were unavailable.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 8 to 17

• Admitted to hospital for treatment of unintentional injury

• Sufficient English fluency to participate in an interview

• Family has access to a telephone (for telephone follow-up contacts)

Exclusion criteria:

• Child's medical status or cognitive functioning precludes participating in an interview

• Child has moderate to severe head injury, defined as Glasgow Coma Score (GCS) <= 12

• Child's injury involved family violence or abuse (physical or sexual)

• No parent or guardian available to consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Children's Hospital of Philadelphia
• Centers for Disease Control and Prevention

Investigators

• Principal Investigator: Nancy Kassam-Adams, PhD, Center for Injury Research and Prevention, Children's Hospital of Philadelphia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT00451282
• Other Study ID Numbers: 2006-9-4974; R49CE000987-01
• First Posted: Mar 23, 2007
• Last Update Posted: Apr 20, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Recruitment Details	Potentially eligible injured patients were identified from patient census and administration lists (n=1330; April 2007 - October 2008). Of 845 eligible children, 149 refused participation, 406 were not approached, usually due to limited parent availability.
Pre-assignment Detail	290 children were enrolled for risk screening, of these 85 (29%) scored positive on one or more screening measures for PTSD and were randomly assigned to receive usual care or the intervention (n=39 and n=46 respectively). 5 intervention subjects did not end up receiving the allocated intervention.

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	Injured children receiving Stepped Preventive Care intervention	Injured children receiving usual care
Period Title: Overall Study
STARTED	46	39
COMPLETED	40	34
NOT COMPLETED	6	5

Baseline Characteristics

Arm/Group Title	Intervention	Usual Care	Total
Arm/Group Description	Injured children receiving Stepped Preventive Care intervention	Injured children receiving usual care	Total of all reporting groups
Overall Participants	46	39	85
Age (Count of Participants)
<=18 years	46 100%	39 100%	85 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.2 (2.2)	11.9 (2.7)	11.5 (2.5)
Sex: Female, Male (Count of Participants)
Female	23 50%	11 28.2%	34 40%
Male	23 50%	28 71.8%	51 60%
Region of Enrollment (participants) [Number]
United States	46 100%	39 100%	85 100%

Outcome Measures

1. Primary Outcome

Title	PTSD Symptoms in Children 6 Weeks Post-injury
Description	The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to of the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	Injured children receiving Stepped Preventive Care intervention	Injured children receiving usual care
Measure Participants	36	28
Mean (Standard Deviation) [Units on a scale]	12.6 (10.2)	13.6 (10.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.69
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	PTSD Symptoms in Children 6 Months Post-injury
Description	The Child PTSD Symptom Scale (CPSS) is a 24-item self-report instrument that yields both a continuous severity score and a determination of likely PTSD diagnostic status according to symptom presence. 17 items corresponding to DSM-IV symptom criteria (and are assumed to yield a PTSD symptom severity score range 0-51) and 7 items assess impairment from those symptoms. The 17 symptom items were administered at baseline (prerandomization), with a score of 15 or greater considered a positive screen for PTSD risk (higher values represent more significant severity of and impairment from PTSD symptoms). The 24-item scale was administered at 6 weeks and 6 months postinjury to assess traumatic stress symptom outcomes.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 31 usual care subjects and 37 intervention subjects completed 6 month follow-up.

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	Injured children receiving Stepped Preventive Care intervention	Injured children receiving usual care
Measure Participants	37	31
Mean (Standard Deviation) [Units on a scale]	12.6 (11.6)	12.2 (9.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.89
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Depression Symptoms in Children 6 Wks Post-injury
Description	The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 28 usual care subjects and 36 intervention subjects completed 6 week follow-up.

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	Injured children receiving Stepped Preventive Care intervention	Injured children receiving usual care
Measure Participants	36	28
Mean (Standard Deviation) [Units on a scale]	15.0 (10.7)	14.0 (10.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.69
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Depression Symptoms in Children 6 Mos Post-injury
Description	The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report measure of depression symptoms that yields a total severity score (range 0-60) . Clinical cut-off scores (≥16 for adults and ≥24 for youth) have been empirically established. Higher values represent more significant severity of symptoms of depression. The CES-D has been validated in adults and children 10 and over as an effective screen for depression. The CES-D was administered at baseline (prerandomization), 6 weeks and 6 months postinjury.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

85 children were randomly assigned to receive usual care (n=39) or the intervention (n=46, 5 did not go on to receive intervention). Of these subjects, 31 usual care subjects and 37 intervention subjects completed 6 week follow-up.

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	Injured children receiving Stepped Preventive Care intervention	Injured children receiving usual care
Measure Participants	37	31
Mean (Standard Deviation) [Units on a scale]	15.6 (13.8)	11.6 (9.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Usual Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.18
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Health-related Quality of Life 6 Weeks and 6 Months Post-injury
Description	The Pediatric Quality of Life Inventory is a well-validated measure of child health-related quality of life. Children completed the measure at baseline to report preinjury functioning and at 6-weeks and 6-months postinjury regarding current functioning. Current analyses utilize the 8-item Physical health/Physical functioning subscale. Scores range from 0-100; higher scores indicate better functioning outcomes.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Adherence With Medical Discharge Instructions
Description	The Health Care Questionnaire for Parents, created for this study, will assess health services utilized post-injury, adherence with specific discharge instructions (e.g., attendance at recommended follow-up appointments), as well as the number of days missed from work (parent) or school (child) related to the injury. Outcome variables to assess adherence will be dichotomized (e.g., attended scheduled appt? yes / no). The Health Care Questionnaire for Primary Care Physicians (PCPs) will assess primary care providers' contacts with study participants, including whether psychosocial concerns were identified since the injury.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Health Service Utilization Over the 6 Months Post-injury
Description	Medical records were used as the primary source of service utilization data; parent report supplemented this information if records were unavailable.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	6 months
Arm/Group Title	Intervention		Usual Care
Arm/Group Description	Injured children receiving Stepped Preventive Care intervention		Injured children receiving usual care
All Cause Mortality
	Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/39 (0%)

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.