Addressing Traumatic Stress Symptoms in Children
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 300
Summary
- Conditions
- Assault
- Parent-Child Relations
- Posttraumatic Stress Disorder
- Violence, Non-accidental
- Youth
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Research assistants (RAs) will perform eligibility screening in the CHOP ED or Trauma Unit on potentially eligible youth and their caregivers who present for care following an assault-related injury. For individuals discharged before being screened, RAs will phone them within 14 days of discharge for screening. Consented youth and caregivers will complete baseline study assessments followed by random assignment to either the intervention [Violence Intervention Program (VIP) with Child and Family Traumatic Stress Intervention (CFTSI)] or control (VIP-only) conditions. VIP is the standard of care provided to assault injured youth treated in the CHOP ED or Trauma Unit. The study coordinator or VIP staff member will notify youth of their assigned condition. CFTSI clinicians will schedule intervention sessions with the families in community-based mental health centers. RAs will be blinded to participant condition and administer baseline and follow-up assessments to all participants.Masking: Single (Outcomes Assessor)Masking Description: Only the study coordinator and VIP staff members will be aware of a participant's randomization assignment. The study research assistants (RAs), who will be responsible for administering baseline, 4-month, and 10-month assessments will be blinded to the participant's study condition throughout the duration of the study.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 8 years and 18 years
- Gender
- Both males and females
Description
Interventions to target modifiable risk and protective factors during the early post-trauma period may promote recovery and reduce posttraumatic stress symptoms (PTSS) following violent injury by facilitating cognitive and emotional processing of trauma reactions, increasing coping capacity, and pro...
Interventions to target modifiable risk and protective factors during the early post-trauma period may promote recovery and reduce posttraumatic stress symptoms (PTSS) following violent injury by facilitating cognitive and emotional processing of trauma reactions, increasing coping capacity, and providing emotional support. Investigators seek 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. Participants will be recruited from Children's Hospital of Philadelphia (CHOP) emergency department (ED) or Trauma Unit following interpersonal assault. Investigators seek to enroll 300 participants from CHOP. Participants must reside in Philadelphia County with a caregiver for at least the last six months, be 8 to 18 years of age (inclusive), have been received for an injury resulting from a qualifying interpersonal assault, and both child and caregiver must be able to speak English. Youth must have a Child Post-traumatic stress disorder (PTSD) Symptom Scale (CPSS) score > or = 11 during study screening.The Child and Family Traumatic Stress Intervention (CFTSI) is the study intervention. The primary outcome measure is youth-reported PTSS at 4 and 10 months.
Tracking Information
- NCT #
- NCT03334942
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Drexel University
- University of Colorado, Denver
- Investigators
- Principal Investigator: Joel Fein, MD, MPH Children's Hospital of Philadelphia