Traumatic Stress Intervention for Post-Traumatic Stress Disorder in Children

Recruiting in Palo Alto (17 mi)

Overseen byJoel Fein, MD, MPH

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Children's Hospital of Philadelphia

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this study is to evaluate the effectiveness of the Child and Family Traumatic Stress Intervention (CFTSI), provided soon after a violent traumatic event, in producing significant and sustained reduction in PTSS among assault injured youth.

Research Team

Joel Fein, MD, MPH

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for English-speaking children aged 8-18 who've experienced a violent event and show signs of stress from it. They need to live in Philadelphia, have a caregiver they've been with for at least 6 months, and score above a threshold on a stress symptom scale. Caregivers must also speak English and be willing to participate.

Inclusion Criteria

Adult must be able to speak English well enough to participate in study activities

Adult is youth's consistent caregiver for at least the past 6 months

Provide permission (informed consent) to participate in study activities. When a caregiver who is a non-legal guardian is identified to be primary caregiver and meet all other eligibility requirements, parental consent will be obtained for child participation in addition to non-legal guardian consent for self-participation.

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Exclusion Criteria

No long-term (< 6 months) caregiver

Exclusion criteria for adult participants:

Not a primary or consistent caregiver for eligible youth for at least 6 months

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Treatment Details

Interventions

Child and Family Traumatic Stress Intervention (Behavioral Intervention)

Trial OverviewThe study tests the Child and Family Traumatic Stress Intervention (CFTSI) aimed at reducing post-traumatic stress symptoms in youth after an assault. It involves both the child and their caregiver soon after the traumatic event.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: CFTSIExperimental Treatment1 Intervention

Youth and caregivers randomized to the Violence Intervention Program (VIP) and Child and Family Traumatic Stress Intervention (CFTSI) arm will receive 5 to 8 CFTSI sessions with a trained clinician and be enrolled in VIP. VIP is the standard clinical service offered to assault injured patients treated in the CHOP ED. Participants in this arm will also complete follow-up assessments approximately 4 and 10 months following the ED visit.

Group II: Violence Intervention ProgramActive Control1 Intervention

Youth and caregivers randomized to the VIP-only condition will complete a baseline assessment prior to randomization and then be enrolled in the Violence Intervention Program (VIP). VIP is the standard clinical service offered to assault injured patients treated in the CHOP ED. Participants in this arm will also complete follow-up assessments approximately 4 and 10 months following the ED visit.