Clinical trial NCT02402205: TF-CBT for Adjudicated Youth in Residential Treatment
Official title: TF-CBT for Adjudicated Youth in Residential Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Implementation; TF-CBT; adjudicated youth; RTF; trauma
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
Collaborators: name: Dartmouth-Hitchcock Medical Center
First posted: 2015-03-30
Enrollment: 210
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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").

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.

Eligibility criteria: 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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Primary outcomes:
measure: Number of youth screened for trauma exposure and PTSD symptoms
timeFrame: Day 1
measure: Number of youth starting TF-CBT
timeFrame: Day 60
measure: Number of youth completing TF-CBT in each condition
timeFrame: Day 240 (6 months post start of treatment)
measure: Fidelity of TF-CBT implementation
timeFrame: Day 240
Secondary outcomes:
measure: Therapy Procedures Checklist
timeFrame: Day 1; Day 900 (30 monhts later)
measure: Attitudes toward Computer Usage Scale
timeFrame: Day 1; Day 900
measure: TF-CBTWeb Knowledge Test
timeFrame: Day 1, Day 900
measure: Youth UCLA PTSD Reaction Index
timeFrame: Day 1; Day 240 (post treatment_
measure: Mood and Feelings Questionnaire-Short Version
timeFrame: Day 1; Day 240 (post treatment)
measure: Youth Satisfaction Survey
timeFrame: Day 240 (post treatment)
Other outcomes:
Locations:
Study officials:
affiliation: West Penn Allegheny Health System
name: Judith A Cohen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: