Addressing Traumatic Stress Symptoms in Children



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:8 - 18
Updated:1/6/2019
Start Date:May 1, 2018
End Date:May 2022
Contact:Joel Fein, MD
Email:Fein@email.chop.edu
Phone:215-590-1944

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Addressing Community Violence-related Traumatic Stress Symptoms in Children

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.

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 the Children's Hospital of Philadelphia (CHOP) emergency
department (ED) or Trauma Unit following interpersonal assault. Investigators seek to enroll
300 participants from CHOP. Participants must reside in Philadelphia County with a parent or
guardian 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
parent 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.

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. Reside with a parent or guardian ("parent") for at least the past 6 months

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 or legal guardian of an eligible youth participant

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

3. Reside with eligible child for at least the past 6 months

4. Provide permission (informed consent)

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 (defined as residing with for < 6 months) parent or parent otherwise
unable to participate in CFTSI

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

- Exclusion criteria for adult participants

1. Not a parent or legal guardian of an eligible youth participant

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. Has not resided with eligible youth for at least 6 months

4. Unable or unwilling to participate in CFTSI
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-590-1944
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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