Clinical trial NCT03334942: Addressing Traumatic Stress Symptoms in Children
Official title: Addressing Community Violence-related Traumatic Stress Symptoms in Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Violence, Non-accidental
Posttraumatic Stress Disorder
Parent-Child Relations
Assault
Youth
Keywords: youth
parents
posttraumatic stress
violence
violent injuries
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Drexel University
name: University of Colorado, Denver
First posted: 2017-11-07
Enrollment: 132
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 4 months post-ED visit.
timeFrame: 4 months
Secondary outcomes:
measure: Change in Revised Children's Anxiety and Depression Scale (RCADS) short form score from baseline to 4 months post-ED visit
timeFrame: 4 months
measure: Change in Revised Children's Anxiety and Depression Scale (RCADS) short form score from baseline to 10 months post-ED visit
timeFrame: 10 months
measure: Change in self-reported substance use as assessed by Behavioral Health Screen (BHS) items from baseline to 4 months post-ED visit
timeFrame: 4 months
measure: Change in self-reported substance use as assessed by Behavioral Health Screen (BHS) items from baseline to 10 months post-ED visit
timeFrame: 10 months
measure: Change in Strengths and Difficulties Questionnaire-Child and Parent Report (SDQ & SDQ-P) from baseline to 4 months post-ED visit
timeFrame: 4 months
measure: Change in Strengths and Difficulties Questionnaire-Child and Parent Report (SDQ & SDQ-P) from baseline to 10 months post-ED visit
timeFrame: 10 months
measure: Change in Child PTSD Symptom Scale (CPSS-5) score from baseline to 10 months post-ED visit.
timeFrame: 10 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Joel Fein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: