Status:
UNKNOWN
Addressing Traumatic Stress Symptoms in Children
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Drexel University
Conditions:
Violence, Non-accidental
Posttraumatic Stress Disorder
Eligibility:
All Genders
8-18 years
Phase:
NA
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 ...
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 faci...
Eligibility Criteria
Inclusion
- Inclusion criteria for youth participants
- 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
- Inclusion criteria for adult participants
- 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.
Exclusion
- Exclusion criteria for youth participants
- 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.
- Exclusion criteria for adult participants
- 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
Key Trial Info
Start Date :
November 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03334942
Start Date
November 2 2017
End Date
May 31 2024
Last Update
August 2 2023
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19146