Clinical trial NCT01649141: Trauma-Focused Cognitive Behavior Therapy for Youth: Effectiveness in a Community Setting
Official title: National Child Traumatic Stress Initiative: Community Treatment and Service Centers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: posttraumatic stress disorder
trauma-focused cognitive behavioral therapy
trauma
child abuse
Lead sponsor: Delaware Division of Prevention and Behavioral Health Services
Sponsor class: OTHER_GOV
Collaborators: name: University of Medicine and Dentistry of New Jersey
name: University of Delaware
First posted: 2012-07-25
Enrollment: 110
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This effectiveness study is being conducted to determine whether Trauma-Focused Cognitive Therapy (TF-CBT), a treatment model developed in specialty clinics by experts in the treatment of child sexual abuse, can be effectively transported to a state-contracted community mental health agency in the state of Delaware and used effectively by clinicians with little prior TF-CBT experience. The sample is comprised of youths receiving public mental health services and with diverse trauma histories.

Detailed description: This investigation aims to examine the effectiveness of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in treating child traumatic stress when implemented in community settings on a state-wide level in Delaware. Youth (ages 7-16 years) with a history of documented trauma (sexual or physical abuse, traumatic loss, domestic or community violence) and symptoms of Posttraumatic Stress Disorder (PTSD) receive approximately 10 sessions of TF-CBT delivered in a state-contracted mental health agency. Children and adolescents are recruited from a public mental health population. PTSD symptoms and internalizing and externalizing behavior problems have been assessed in the first 72 participants at pre-treatment and then at 3-, 6-, 9-, and 12-months after intake; subsequent participants (n=38) are only being assessed for symptoms and problems at pre-treatment and then at 3-, 6-months after intake.

Eligibility criteria: Inclusion Criteria:

* child is 7-17 years old
* positive screen for PTSD
* child qualifies for public insurance
* parent willing to co-participate in treatment
* English-speaking (child and parent)

Exclusion Criteria:

* intellectual disability (child)
* untreated psychosis (child)
* untreated substance abuse (child)
* sibling already in study
* unable to participate in year-long follow-up (e.g., moving out of state)

Primary outcomes:
measure: Change in baseline PTSD Symptoms at 3-,6-,9- and 12-months
timeFrame: Baseline and post-baseline (3-,6-,9-,12-months)
Secondary outcomes:
measure: Change in baseline behavioral problems at 3-, 6-, 9- and 12-months.
timeFrame: Baseline and post-baseline (3-,6-,9-,12-months)
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Division of Prevention and Behavioral Health Services
state: Delaware
Study officials:
affiliation: Division of Prevention and Behavioral Health Services
name: Charles P Webb, Ph.D.
role: STUDY_DIRECTOR
affiliation: Division of Prevention and Behavioral Health Services
name: Nancy Widdoes, M.A.
role: PRINCIPAL_INVESTIGATOR
References: