This trial is active, not recruiting.

Condition posttraumatic stress disorder
Treatment trauma-focused cognitive behavioral therapy
Sponsor Delaware Division of Prevention and Behavioral Health Services
Collaborator University of Medicine and Dentistry of New Jersey
Start date August 2006
End date December 2012
Trial size 110 participants
Trial identifier NCT01649141, SM57145


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Trauma-Focused Cognitive Behavioral Therapy
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).

Primary Outcomes

Change in baseline PTSD Symptoms at 3-,6-,9- and 12-months
time frame: Baseline and post-baseline (3-,6-,9-,12-months)

Secondary Outcomes

Change in baseline behavioral problems at 3-, 6-, 9- and 12-months.
time frame: Baseline and post-baseline (3-,6-,9-,12-months)

Eligibility Criteria

Male or female participants from 7 years up to 17 years old.

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)

Additional Information

Official title National Child Traumatic Stress Initiative: Community Treatment and Service Centers
Principal investigator Nancy Widdoes, M.A.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Delaware Division of Prevention and Behavioral Health Services.