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

NCT01649141 | Unknown

• 1 other identifier: SM57145
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

posttraumatic stress disorder; trauma-focused cognitive behavioral therapy; trauma; child abuse

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline and post-baseline (3-,6-,9-,12-months)

Secondary Outcomes (1)

• Change in baseline behavioral problems at 3-, 6-, 9- and 12-months.

  Baseline and post-baseline (3-,6-,9-,12-months)

Study Arms (1)

Treatment Group

EXPERIMENTAL

Trauma-Focused Cognitive Behavioral Therapy

Behavioral: Trauma-Focused Cognitive Behavioral Therapy

Interventions

Trauma-Focused Cognitive Behavioral Therapy BEHAVIORAL

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).

Treatment Group

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Delaware Division of Prevention and Behavioral Health Services: lead
• University of Medicine and Dentistry of New Jersey: collaborator
• University of Delaware: collaborator

Study Sites (1)

Division of Prevention and Behavioral Health Services

Wilmington, Delaware, 19805, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Charles P Webb, Ph.D.

  Division of Prevention and Behavioral Health Services

  STUDY DIRECTOR

• Nancy Widdoes, M.A.

  Division of Prevention and Behavioral Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 25, 2012
• Study Start: August 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 25, 2012

Record last verified: 2012-07

Locations

US (1)