- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01649141
Trauma-Focused Cognitive Behavior Therapy for Youth: Effectiveness in a Community Setting
July 20, 2012 updated by: Delaware Division of Prevention and Behavioral Health Services
National Child Traumatic Stress Initiative: Community Treatment and Service Centers
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delaware
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Wilmington, Delaware, United States, 19805
- Division of Prevention and Behavioral Health Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Trauma-Focused Cognitive Behavioral Therapy
|
Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is a structured, 12-16 session outpatient intervention originally developed to treat Posttraumatic Stress Disorder (PTSD) and related emotional and behavioral difficulties in youth with a history of child sexual abuse.
TF-CBT's eight components are delivered in 90-minute weekly sessions split evenly between children and their parents.
These components are summarized by the acronym PRACTICE including: psychoeducation and parenting skills (P), relaxation (R), affective expression and regulation (A), cognitive coping (C), trauma narrative development and processing (T), in vivo gradual exposure (I), conjoint parent/child sessions (C) and enhancing safety and future development (E).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in baseline PTSD Symptoms at 3-,6-,9- and 12-months
Time Frame: Baseline and post-baseline (3-,6-,9-,12-months)
|
PTSD symptoms area assessed with the UCLA PTSD Reaction Index for DSM-IV (UPID).
The UPID (Pynoos, et al., 1998) includes 48 items that can be administered as a questionnaire or structured interview.
The instrument's three sections assess for trauma exposure and symptoms of DSM-IV PTSD in children ages 7-18.
The UPID has good convergent validity (i.e., 0.70 in comparison to the K-SADS, epidemiologic version), a sensitivity of 0.93 and specificity of 0.87 in diagnosing PTSD (Steinberg et al., 2004), and test-retest reliability of 0.84 (Steinberg et al., 2004)
|
Baseline and post-baseline (3-,6-,9-,12-months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in baseline behavioral problems at 3-, 6-, 9- and 12-months.
Time Frame: Baseline and post-baseline (3-,6-,9-,12-months)
|
Behavioral problems are assessed with the parent version of the Child Behavior Checklist 6-18 (CBCL: Achenbach, & Rescorla, 2001)\.The CBCL is a 113-item parent self-report measure used to assess children's emotional and behavioral problems and social competencies.
The CBCL has been used with acceptable levels of reliability (range 0.84-0.98)
and content and criterion validity to measure mental health problems of children ages 6-18 years from diverse racial and ethnic backgrounds (Achenbach & Rescorla, 2001).
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Baseline and post-baseline (3-,6-,9-,12-months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Charles P Webb, Ph.D., Division of Prevention and Behavioral Health Services
- Principal Investigator: Nancy Widdoes, M.A., Division of Prevention and Behavioral Health Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
July 19, 2012
First Submitted That Met QC Criteria
July 20, 2012
First Posted (Estimate)
July 25, 2012
Study Record Updates
Last Update Posted (Estimate)
July 25, 2012
Last Update Submitted That Met QC Criteria
July 20, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SM57145
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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