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PTSDNCT02402205

TF-CBT for Adjudicated Youth in Residential Treatment

A study testing TF-CBT in people with PTSD, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
PTSD
What is being tested?
TF-CBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
No sites listed yet
Study dates
Jul 2011to Nov 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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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About this study

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").

Read the 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.

Conditions
PTSD
Being tested
TF-CBT
Keywords
Implementation; TF-CBT; adjudicated youth; RTF; trauma
Medical subject headings
Stress Disorders, Post-Traumatic, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TF-CBTBehavioural

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

Study groups in NCT02402205
Study groupRoleWhat they receive
Web Implementation of TF-CBTExperimentalWeb 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.
Receives: Behavioral: TF-CBT
Web + Live Implementation of TF-CBTExperimentalWeb + 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.
Receives: Behavioral: TF-CBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 1

  2. Number of youth starting TF-CBT

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

    Measured: Day 60

  3. Number of youth completing TF-CBT in each condition

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

    Measured: Day 240 (6 months post start of treatment)

  4. Fidelity of TF-CBT implementation

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

    Measured: Day 240

Secondary outcomes (6)

  1. 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

    Measured: Day 1; Day 900 (30 monhts later)

  2. Attitudes toward Computer Usage Scale

    Attitudes toward computer usage as a potential covariate of outcomes

    Measured: Day 1; Day 900

  3. TF-CBTWeb Knowledge Test

    Change in knowledge related to TF-CBT as a moderator of outcomes

    Measured: Day 1, Day 900

  4. Youth UCLA PTSD Reaction Index

    Change in youth PTSD scores across and between implementation conditions to be examined as a secondary outcome

    Measured: Day 1; Day 240 (post treatment_

  5. Mood and Feelings Questionnaire-Short Version

    Change in youth depression scores in youth across and between implementation conditions

    Measured: Day 1; Day 240 (post treatment)

  6. Youth Satisfaction Survey

    Youth satisfaction with therapy across and between implementation conditions

    Measured: Day 240 (post treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2015 (estimated)
  2. Study startJul 2011
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02402205
Sponsor's protocol ID
R01MH095208
Status last verified
Mar 2015
First submitted
25 Mar 2015
Last updated
30 Mar 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing TF-CBT in people with PTSD, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of youth screened for trauma exposure and PTSD symptoms (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02402205.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.

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