TF-CBT for Adjudicated Youth in Residential Treatment

March 27, 2015 updated by: Judith Cohen, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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).

-

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of youth screened for trauma exposure and PTSD symptoms
Time Frame: Day 1
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
Time Frame: Day 60
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
Time Frame: Day 240 (6 months post start of treatment)
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
Time Frame: Day 240
Therapist fidelity implementing TF-CBT across and between implementation conditions using TF-CBT Fidelity Checklist (online version)
Day 240

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Therapy Procedures Checklist
Time Frame: Day 1; Day 900 (30 monhts later)
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
Time Frame: Day 1; Day 900
Attitudes toward computer usage as a potential covariate of outcomes
Day 1; Day 900
TF-CBTWeb Knowledge Test
Time Frame: Day 1, Day 900
Change in knowledge related to TF-CBT as a moderator of outcomes
Day 1, Day 900
Youth UCLA PTSD Reaction Index
Time Frame: Day 1; Day 240 (post treatment_
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
Time Frame: Day 1; Day 240 (post treatment)
Change in youth depression scores in youth across and between implementation conditions
Day 1; Day 240 (post treatment)
Youth Satisfaction Survey
Time Frame: Day 240 (post treatment)
Youth satisfaction with therapy across and between implementation conditions
Day 240 (post treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dartmouth-Hitchcock Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Judith A Cohen, M.D., West Penn Allegheny Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH095208 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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