TF-CBT for Adjudicated Youth in Residential Treatment

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").

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Behavioral: TF-CBT

Detailed Description

Therapists in each of 18 participating RTFprograms that serve adjudicated youth are randomized to receive either:

1. W TF-CBT implementation strategy, provided via the free distance learning resources TF-CBTWeb, (www.musc/edu/tfcbt) and TF-CBTConsult (www.musc.edu/tfcbtconsult); or
2. W+L implementation strategy, provided through W + 2 day TF-CBT training plus one year of twice monthly TF-CBT consultation calls with a TF-CBT expert trainer.

All RTF staff receive one day training in trauma-informed care. All therapists in both conditions receive training in screening youth for trauma exposure and symptoms. Data are collected regarding primary outcomes of: 1) number of youth therapists in each condition screen for trauma symptoms, 2) number of youth consent to TF-CBT treatment; 3) number of youth complete TF-CBT, 4) TF-CBT fidelity during treatment. Secondary outcomes include 1)changes in therapist knowledge and satisfaction regarding TF-CBT treatment and 2) youth outcomes including PTSD symptoms, depression and satisfaction with treatment.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Consenting mental health therapists in participating residential treatment facilities (RTF)in New Hampshire, Vermont and Connecticut; and the adjudicated youth ages 12-17 years old who are residents in these RTF programs being treated by the participating therapists who 1) are screened positive for having at least one past trauma experience with UCLA PTSD Reaction Index score of >22; 2) assent with legal guardian consent to participate in the project; and 3) are anticipated to remain in the RTF program at least 3 months (long enough to receive TF-CBT treatment).

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Exclusion Criteria: Guardian or youth refuses;youth does not endorse trauma exposure or symptoms; youth is being discharged too soon to participate; Therapist may use clinical judgment to exclude youth from study based on clinical presentation.

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Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Web Implementation of TF-CBT; 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 TF-CBT implementation or Web + Live TF-CBT implementation
Experimental: Web + Live Implementation of TF-CBT; 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; Web TF-CBT implementation or Web + Live TF-CBT implementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapy Procedures Checklist	Therapist comfort with cognitive therapy practices (or change in this during the study) as a predictor of other outcomes between the W vs. W+L group	Day 1; Day 900 (30 monhts later)
Attitudes toward Computer Usage Scale	Attitudes toward computer usage as a potential covariate of outcomes	Day 1; Day 900
TF-CBTWeb Knowledge Test	Change in knowledge related to TF-CBT as a moderator of outcomes	Day 1, Day 900
Youth UCLA PTSD Reaction Index	Change in youth PTSD scores across and between implementation conditions to be examined as a secondary outcome	Day 1; Day 240 (post treatment_
Mood and Feelings Questionnaire-Short Version	Change in youth depression scores in youth across and between implementation conditions	Day 1; Day 240 (post treatment)
Youth Satisfaction Survey	Youth satisfaction with therapy across and between implementation conditions	Day 240 (post treatment)

Collaborators and Investigators

• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Collaborators: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Judith A Cohen, M.D., West Penn Allegheny Health System

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: March 25, 2015
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Implementation; TF-CBT; adjudicated youth; RTF; trauma
• Other Study ID Numbers: R01MH095208 (U.S. NIH Grant/Contract)