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Addressing Traumatic Stress Symptoms in Children

NCT03334942 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2023-08-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Child and Family Traumatic Stress Intervention

The Child and Family Traumatic Stress Intervention (CFTSI) is a 5-8 session intervention, initiated within 60 days of trauma exposure for youth reporting acute PTSS. CFTSI is designed for children age 7 and older, and requires the involvement of a caregiver who knows the child well enough to report changes in the child's behavior and symptoms. CFTSI targets modifiable risk and protective factors during the early post-trauma period to promote recovery and reduce PTSS via caregiver-child communication and cognitive and emotional processing. CFTSI uses skill modules (e.g., sleep disturbance, intrusive thoughts, anxiety) to teach effective strategies to decrease a child's PTSS. Coping and communication skills are taught and practiced in caregiver-child sessions and in the home.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Drexel University

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Children's Hospital of Philadelphia

    lead OTHER

Principal Investigators

  • Joel Fein, MD, MPH · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-02
Primary Completion
2023-12-31
Completion
2024-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03334942 on ClinicalTrials.gov