Addressing Traumatic Stress Symptoms in Children

NCT03334942 | Unknown DMC

• 2 other identifiers: 17-013839R01HD087406-01A1
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Violence, Non-accidental; Posttraumatic Stress Disorder; Parent-Child Relations; Assault; Youth

Keywords

youth; parents; posttraumatic stress; violence; violent injuries

Outcome Measures

Primary Outcomes (1)

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

  Assesses the severity of posttraumatic stress symptoms in youth ages 8 to 18 years old. Items correspond to DSM-5 PTSD symptom criteria. Symptom items are rated on a Likert-type scale (0-1-2-3-4) corresponding to "not at all" to "6 or more times a week/almost always." The CPSS yields a symptom severity score (sum of responses) and can be scored for possible PTSD diagnosis. Possible CPSS-5 scores range from 0 to 80. Based on the current evidence regarding screening for PTSD risk, we will employ a screening cut-off (greater than or equal to 11) on the summed CPSS severity score from 20 symptom items, indicating moderate PTSS.

  4 months

Secondary Outcomes (7)

• Change in Revised Children's Anxiety and Depression Scale (RCADS) short form score from baseline to 4 months post-ED visit

  4 months

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

  10 months

• Change in self-reported substance use as assessed by Behavioral Health Screen (BHS) items from baseline to 4 months post-ED visit

  4 months

• Change in self-reported substance use as assessed by Behavioral Health Screen (BHS) items from baseline to 10 months post-ED visit

  10 months

• Change in Strengths and Difficulties Questionnaire-Child and Parent Report (SDQ & SDQ-P) from baseline to 4 months post-ED visit

  4 months

Study Arms (2)

CFTSI

EXPERIMENTAL

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.

Behavioral: Child and Family Traumatic Stress Intervention

Violence Intervention Program

NO 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.

Interventions

Child and Family Traumatic Stress Intervention BEHAVIORAL

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.

Also known as: CFTSI

CFTSI

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males or females age 8 to 18 years (inclusive)
• Received treatment in the CHOP ED or trauma unit for an injury resulting from a qualifying interpersonal assault
• Child must be able to speak English well enough to participate in study activities
• Child must reside in Philadelphia County (191xx zip code)
• Identifies a consistent caregiver for at least the past 6 months. This may include a parent, legal guardian, or another adult (e.g. grandparent, adult sibling, aunt/uncle, etc.).
• Child PTSD Symptom Scale (CPSS) score \> or = 11 in ED or on screening telephone call
• Parental/guardian permission (informed consent) and child assent
• Parent, legal guardian, or other caregiver of an eligible youth participant. Other caregivers may include non-legal guardians who meet all other study eligibility requirements and have approval of the participating child's parent/legal guardian to participate in study activities.
• 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.

You may not qualify if:

• Age younger than 8 or older than 18 years
• Youth who is non-English speaking or for other reasons is unable to understand and answer study questions and participate in study activities
• Youth hospitalized for greater than 14 days (unable to achieve timely study enrollment)
• No long-term (\< 6 months) caregiver
• Index injury in the ED due to family violence (assaulted by a parent, sibling, or other family/household member), sexual assault, or fights with police, security, or school personnel
• In residential placement at time of ED visit
• Parent or legal guardian unable to provide consent for youth participation.
• Not a primary or consistent caregiver for eligible youth for at least 6 months
• Adult who is non-English speaking or for other reasons is unable to understand and answer study questions and participate in study activities
• Unable or unwilling to participate in CFTSI

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Drexel University: collaborator
• University of Colorado, Denver: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Joel Fein, MD, MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: November 7, 2017
• Study Start: November 2, 2017
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)