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

Posttraumatic Stress Disorder Clinical Trial

Official title:

National Child Traumatic Stress Initiative: Community Treatment and Service Centers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01649141
• Other study ID #: SM57145
• Status: Active, not recruiting
• Phase: N/A
• First received: July 19, 2012
• Last updated: July 20, 2012
• Start date: August 2006
• Est. completion date: December 2012

Study information

• Verified date: July 2012
• Source: Delaware Division of Prevention and Behavioral Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Substance Abuse and Mental Health Services AdministrationUnited States: National Child Traumatic Stress NetworkUnited States: Western Institutional Review BoardUnited States: State of Delaware
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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).

Locations

Country	Name	City	State
United States	Division of Prevention and Behavioral Health Services	Wilmington	Delaware

Sponsors (3)

Lead Sponsor	Collaborator
Delaware Division of Prevention and Behavioral Health Services	University of Delaware, University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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).	Baseline and post-baseline (3-,6-,9-,12-months)	No