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Trauma-Focused Cognitive Behavior Therapy for Youth: Effectiveness in a Community Setting

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Medicine and Dentistry New Jersey
University of Delaware
Information provided by (Responsible Party):
Delaware Division of Prevention and Behavioral Health Services
ClinicalTrials.gov Identifier:
NCT01649141
First received: July 19, 2012
Last updated: July 20, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
 Behavioral: Trauma-Focused Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: National Child Traumatic Stress Initiative: Community Treatment and Service Centers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Delaware Division of Prevention and Behavioral Health Services:

Primary Outcome Measures:
  • Change in baseline PTSD Symptoms at 3-,6-,9- and 12-months [ Time Frame: Baseline and post-baseline (3-,6-,9-,12-months) ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Change in baseline behavioral problems at 3-, 6-, 9- and 12-months. [ Time Frame: Baseline and post-baseline (3-,6-,9-,12-months) ] [ Designated as safety issue: No ]
    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).


Enrollment: 110
Study Start Date: August 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649141

Locations
United States, Delaware
Division of Prevention and Behavioral Health Services
Wilmington, Delaware, United States, 19805
Sponsors and Collaborators
Delaware Division of Prevention and Behavioral Health Services
University of Medicine and Dentistry New Jersey
University of Delaware
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
  More Information

No publications provided

Responsible Party: Delaware Division of Prevention and Behavioral Health Services
ClinicalTrials.gov Identifier: NCT01649141     History of Changes
Other Study ID Numbers: SM57145
Study First Received: July 19, 2012
Last Updated: July 20, 2012
Health Authority: United States: Substance Abuse and Mental Health Services Administration
United States: National Child Traumatic Stress Network
United States: Western Institutional Review Board
United States: State of Delaware

Keywords provided by Delaware Division of Prevention and Behavioral Health Services:
posttraumatic stress disorder
trauma-focused cognitive behavioral therapy
trauma
child abuse

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013