Trauma-Focused Cognitive Behavior Therapy for Youth: Effectiveness in a Community Setting
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|ClinicalTrials.gov Identifier: NCT01649141|
Recruitment Status : Unknown
Verified July 2012 by Delaware Division of Prevention and Behavioral Health Services.
Recruitment status was: Active, not recruiting
First Posted : July 25, 2012
Last Update Posted : July 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Behavioral: Trauma-Focused Cognitive Behavioral Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||National Child Traumatic Stress Initiative: Community Treatment and Service Centers|
|Study Start Date :||August 2006|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Experimental: Treatment Group
Trauma-Focused Cognitive Behavioral Therapy
Behavioral: 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).
- 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)
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649141
|United States, Delaware|
|Division of Prevention and Behavioral Health Services|
|Wilmington, Delaware, United States, 19805|
|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|