TF-CBT for Adjudicated Youth in Residential Treatment

NCT02402205 | Completed DMC

• 1 other identifier: R01MH095208
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief Summary

Adjudicated youth often have traumatic stress responses but rarely receive treatment for these problems. This study is a randomized controlled trial to evaluate two alternative implementation strategies for providing an evidence-based trauma treatment, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), to therapist who treat adjudicated youth in 18 residential treatment facilities (RTF) in New Hampshire, Vermont, and Connecticut: 1) web-based TF-CBT implementation strategy ("W"), consisting on only web-based training and consultation; versus 2) W plus live TF-CBT implementation strategy, consisting of W plus face-to face training and phone consultation with TF-CBT experts ("W+L").

Conditions

PTSD

Keywords

Implementation; TF-CBT; adjudicated youth; RTF; trauma

Outcome Measures

Primary Outcomes (4)

• Number of youth screened for trauma exposure and PTSD symptoms

  Number of youth screened for trauma exposure and PTSD symptoms using the UCLA PTSD Reaction Index (online version)in W vs. W+L implementation condition

  Day 1

• Number of youth starting TF-CBT

  Number of youth who begin TF-CBT treatment in W vs W+L implementation condition

  Day 60

• Number of youth completing TF-CBT in each condition

  Number of youth completing TF-CBT in W vs W+L conditions

  Day 240 (6 months post start of treatment)

• Fidelity of TF-CBT implementation

  Therapist fidelity implementing TF-CBT across and between implementation conditions using TF-CBT Fidelity Checklist (online version)

  Day 240

Secondary Outcomes (6)

• Therapy Procedures Checklist

  Day 1; Day 900 (30 monhts later)

• Attitudes toward Computer Usage Scale

  Day 1; Day 900

• TF-CBTWeb Knowledge Test

  Day 1, Day 900

• Youth UCLA PTSD Reaction Index

  Day 1; Day 240 (post treatment_

• Mood and Feelings Questionnaire-Short Version

  Day 1; Day 240 (post treatment)

Study Arms (2)

Web Implementation of TF-CBT

EXPERIMENTAL

Web implementation ("W")provides only web-based (distance learning) training and consultation to mental health therapists providing TF-CBT treatment to adjudicated youth in RTF. Therapists access the initial 10 hour training course(www.musc.edu/tfcbt) and follow-up consultation (www.musc.edu/tfcbtconsult) at their own convenience and as needed during the course of the study, with RTF administrators guaranteeing that therapists have time to do so. This implementation strategy is free and more convenient to therapists and administrators as it can be accessed whenever desired.

Behavioral: TF-CBT

Web + Live Implementation of TF-CBT

EXPERIMENTAL

Web + Live ("W+L") implementation provides web-based training and consultation as described in W, and also provides 1) face-to-face training and 2) twice monthly phone consultation with an expert TF-CBT trainer. W+L requires greater resource commitment from therapists and administrators and is less convenient, but provides more specific consultation on the therapists' personal TF-CBT treatment cases.

Behavioral: TF-CBT

Interventions

TF-CBT BEHAVIORAL

Web TF-CBT implementation or Web + Live TF-CBT implementation

Web + Live Implementation of TF-CBT; Web Implementation of TF-CBT

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• Dartmouth-Hitchcock Medical Center: collaborator

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

• Judith A Cohen, M.D.

  West Penn Allegheny Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Professor of Psychiatry, Allegheny General Hospital, Drexel University College of Medicine

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: March 30, 2015
• Study Start: July 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 30, 2015

Record last verified: 2015-03