Trial Outcomes & Findings for Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury (NCT NCT00451282)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

290 participants

Primary outcome timeframe

6 weeks

Results posted on

2015-04-20

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Intervention Injured children receiving Stepped Preventive Care intervention	Usual Care Injured children receiving usual care
Overall Study STARTED	46	39
Overall Study COMPLETED	40	34
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Injured children receiving Stepped Preventive Care intervention	Usual Care Injured children receiving usual care
Overall Study Lost to Follow-up	6	5

Baseline Characteristics

Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=46 Participants Injured children receiving Stepped Preventive Care intervention	Usual Care n=39 Participants Injured children receiving usual care	Total n=85 Participants Total of all reporting groups
Age, Categorical <=18 years	46 Participants n=5 Participants	39 Participants n=7 Participants	85 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	11.2 years STANDARD_DEVIATION 2.2 • n=5 Participants	11.9 years STANDARD_DEVIATION 2.7 • n=7 Participants	11.5 years STANDARD_DEVIATION 2.5 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	11 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	28 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	39 participants n=7 Participants	85 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=36 Participants Injured children receiving Stepped Preventive Care intervention	Usual Care n=28 Participants Injured children receiving usual care
PTSD Symptoms in Children 6 Weeks Post-injury	12.6 Units on a scale Standard Deviation 10.2	13.6 Units on a scale Standard Deviation 10.7

PRIMARY outcome

Timeframe: 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=37 Participants Injured children receiving Stepped Preventive Care intervention	Usual Care n=31 Participants Injured children receiving usual care
PTSD Symptoms in Children 6 Months Post-injury	12.6 Units on a scale Standard Deviation 11.6	12.2 Units on a scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: 6 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=36 Participants Injured children receiving Stepped Preventive Care intervention	Usual Care n=28 Participants Injured children receiving usual care
Depression Symptoms in Children 6 Wks Post-injury	15.0 Units on a scale Standard Deviation 10.7	14.0 Units on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=37 Participants Injured children receiving Stepped Preventive Care intervention	Usual Care n=31 Participants Injured children receiving usual care
Depression Symptoms in Children 6 Mos Post-injury	15.6 Units on a scale Standard Deviation 13.8	11.6 Units on a scale Standard Deviation 9.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Kassam-Adams

Children's Hospital of Philadelphia

Phone: 215-590-3118

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place