Addressing Traumatic Stress Symptoms in Children

Children's Hospital of Philadelphia (CHOP)

Status: Active, not recruiting

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

Treatments: Behavioral: Child and Family Traumatic Stress Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03334942

R01HD087406-01A1 (U.S. NIH Grant/Contract)

17-013839

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria for youth participants

  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

• Inclusion criteria for adult participants

  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

• Exclusion criteria for youth participants

  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.

• Exclusion criteria for adult participants

  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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

CFTSI

Experimental group

Description:

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.

Treatment:

Behavioral: Child and Family Traumatic Stress Intervention

Violence Intervention Program

No Intervention group

Description:

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.