TF-CBT for Adjudicated Youth in Residential Treatment

PTSD Clinical Trial

Official title:

TF-CBT for Adjudicated Youth in Residential Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402205
• Other study ID #: R01MH095208
• Status: Completed
• Phase: N/A
• First received: March 25, 2015
• Last updated: March 27, 2015
• Start date: July 2011
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Allegheny Singer Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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").

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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).

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• TF-CBT
Web TF-CBT implementation or Web + Live TF-CBT implementation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute	Dartmouth-Hitchcock Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Number of youth starting TF-CBT	Number of youth who begin TF-CBT treatment in W vs W+L implementation condition	Day 60	No
Primary	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)	No
Primary	Fidelity of TF-CBT implementation	Therapist fidelity implementing TF-CBT across and between implementation conditions using TF-CBT Fidelity Checklist (online version)	Day 240	No
Secondary	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)	No
Secondary	Attitudes toward Computer Usage Scale	Attitudes toward computer usage as a potential covariate of outcomes	Day 1; Day 900	No
Secondary	TF-CBTWeb Knowledge Test	Change in knowledge related to TF-CBT as a moderator of outcomes	Day 1, Day 900	No
Secondary	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_	No
Secondary	Mood and Feelings Questionnaire-Short Version	Change in youth depression scores in youth across and between implementation conditions	Day 1; Day 240 (post treatment)	No
Secondary	Youth Satisfaction Survey	Youth satisfaction with therapy across and between implementation conditions	Day 240 (post treatment)	No