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

Primary Purpose

Posttraumatic Stress Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-Focused Cognitive Behavioral Therapy
Sponsored by
Delaware Division of Prevention and Behavioral Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring posttraumatic stress disorder, trauma-focused cognitive behavioral therapy, trauma, child abuse

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Division of Prevention and Behavioral Health Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Trauma-Focused Cognitive Behavioral Therapy

Outcomes

Primary Outcome Measures

Change in baseline PTSD Symptoms at 3-,6-,9- and 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)

Secondary Outcome Measures

Change in baseline behavioral problems at 3-, 6-, 9- and 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).

Full Information

First Posted
July 19, 2012
Last Updated
July 20, 2012
Sponsor
Delaware Division of Prevention and Behavioral Health Services
Collaborators
University of Medicine and Dentistry of New Jersey, University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT01649141
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Delaware Division of Prevention and Behavioral Health Services
Collaborators
University of Medicine and Dentistry of New Jersey, University of Delaware

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
posttraumatic stress disorder, trauma-focused cognitive behavioral therapy, trauma, child abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Trauma-Focused Cognitive Behavioral Therapy
Intervention Type
Behavioral
Intervention Name(s)
Trauma-Focused Cognitive Behavioral Therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in baseline PTSD Symptoms at 3-,6-,9- and 12-months
Description
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)
Time Frame
Baseline and post-baseline (3-,6-,9-,12-months)
Secondary Outcome Measure Information:
Title
Change in baseline behavioral problems at 3-, 6-, 9- and 12-months.
Description
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).
Time Frame
Baseline and post-baseline (3-,6-,9-,12-months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles P Webb, Ph.D.
Organizational Affiliation
Division of Prevention and Behavioral Health Services
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nancy Widdoes, M.A.
Organizational Affiliation
Division of Prevention and Behavioral Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Prevention and Behavioral Health Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19805
Country
United States

12. IPD Sharing Statement

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

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