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Behavioral Intervention

Traumatic Stress Intervention for Post-Traumatic Stress Disorder in Children

N/A

Waitlist Available

Led By Joel Fein, MD, MPH

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Age younger than 8 or older than 18 years

Unable or unwilling to participate in CFTSI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a specific intervention reduces post-traumatic stress symptoms in young people who have experienced violence.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since CFTSI is a therapeutic intervention rather than medication, typical drug side effects are not expected. However, discussing traumatic events may cause temporary distress or emotional discomfort.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am either younger than 8 or older than 18 years old.

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I am not able to or do not want to join in CFTSI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 4 months post-ED visit.

Secondary study objectives

Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 10 months post-ED visit.

Change in Revised Children's Anxiety and Depression Scale (RCADS) short form score from baseline to 10 months post-ED visit

Anxiety

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met