Addressing Traumatic Stress Symptoms in Children

NCT ID: NCT03334942

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-02
• Study Completion Date: 2024-05-31

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.

Detailed 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 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 110 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CFTSI

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 Type: EXPERIMENTAL

Child and Family Traumatic Stress Intervention

Intervention Type: 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.

Violence Intervention Program

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CFTSI

Eligibility Criteria

Inclusion Criteria

1. Males or females age 8 to 18 years (inclusive)

2. Received treatment in the CHOP ED or trauma unit for an injury resulting from a qualifying interpersonal assault

3. Child must be able to speak English well enough to participate in study activities

4. Child must reside in Philadelphia County (191xx zip code)

5. 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.).

6. Child PTSD Symptom Scale (CPSS) score > or = 11 in ED or on screening telephone call

7. Parental/guardian permission (informed consent) and child assent

1. 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.

2. Adult must be able to speak English well enough to participate in study activities

3. Adult is youth's consistent caregiver for at least the past 6 months

4. 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.

Exclusion Criteria

1. Age younger than 8 or older than 18 years

2. Youth who is non-English speaking or for other reasons is unable to understand and answer study questions and participate in study activities

3. Youth hospitalized for greater than 14 days (unable to achieve timely study enrollment)

4. No long-term (< 6 months) caregiver

5. 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

6. In residential placement at time of ED visit

7. Parent or legal guardian unable to provide consent for youth participation.

1. Not a primary or consistent caregiver for eligible youth for at least 6 months

2. Adult who is non-English speaking or for other reasons is unable to understand and answer study questions and participate in study activities

3. Unable or unwilling to participate in CFTSI

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel Fein, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R01HD087406-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-013839

Identifier Type: -

Identifier Source: org_study_id