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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 4 months post-ED visit.
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
707 Previous Clinical Trials
8,581,159 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,609 Total Patients Enrolled
Drexel UniversityOTHER
150 Previous Clinical Trials
47,583 Total Patients Enrolled

Media Library

Child and Family Traumatic Stress Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03334942 — N/A
Post-Traumatic Stress Disorder Research Study Groups: CFTSI, Violence Intervention Program
Post-Traumatic Stress Disorder Clinical Trial 2023: Child and Family Traumatic Stress Intervention Highlights & Side Effects. Trial Name: NCT03334942 — N/A
Child and Family Traumatic Stress Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03334942 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for participants in this trial?

"The information found on clinicaltrials.gov confirms that this medical trial is presently recruiting patients. This study was first publicised in November 2017 and the most recent update occurred in April of 2022."

Answered by AI

What is the upper-limit of participants in this trial?

"Indeed, the information hosted on clinicaltrials.gov verifies that recruitment for this trial is taking place. The trial was first listed in November 2017 and later revised April 2022, with a goal of 110 patients from 1 participating centre."

Answered by AI

What conditions must a person satisfy to be eligible for this research initiative?

"This medical trial seeks 110 participants aged between 8 and 18 that have experienced moral injury. To be considered, candidates ought to satisfy the following eligibility requirements: For minors, they must be of either gender with an age ranging from 8 to 18 years old; they should also have received treatment in CHOP ED or trauma unit for a qualifying interpersonal assault, possess a Child PTSD Symptom Scale score of 11 or higher at time of admission/medical screening telephone call, etc. Meanwhile adults need to hold parental authority over their child-participant or function as another approved caregiver (e.g grandparent)."

Answered by AI

Can individuals aged 35 and over partake in this scientific inquiry?

"This scientific study is open to any participant over the age of 8 and below 18."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Children's Hospital of Philadelphia
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Addressing Traumatic Stress Symptoms in Children
2017. "Addressing Traumatic Stress Symptoms in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03334942.
All > Ptsd New York > Ptsd
~18 spots leftby Apr 2025
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