- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01800266
Randomized Controlled Trial of Supervision Strategies to Improve Clinician Fidelity to Trauma-focused CBT (STEPS)
Improving Practice in Community-based Settings: A Randomized Trial of Supervision Strategies
The primary goal of this study is to examine the impact of varying supervision strategies on clinician fidelity and client outcomes in a community-based setting. Prior research has established that training approaches that do not include a period of intervention-specific supervision or consultation are ineffective and that implementation efforts that include only an initial period of supervision show an eventual attenuation of gains in knowledge and fidelity in practice. Ongoing supervision may be required for effective and sustained implementation of evidence-based practices (EBPs) in community-based settings. However, supervision is one of the least investigated aspects of training. "Gold standard" elements of supervision from efficacy trials include review of sessions, standardized procedures for monitoring client outcomes and model fidelity, and ongoing skill-building (e.g., behavioral rehearsal). The degree (e.g., frequency, intensity) to which these strategies are used in community-based settings is unknown.
There are a growing number of national and statewide efforts to increase the reach of EBPs through dissemination and implementation initiatives. There are 18 statewide initiatives to implement Trauma-focused Cognitive Behavioral Therapy (TF-CBT), an EBP for child trauma exposure and sequelae. Many of the community based TF-CBT implementation efforts, and those for other EBPs, include a specific focus on supervisors. However, the limited scientific literature provides very little guidance for these efforts. Aims of the current trial include 1) studying supervision with existing implementation supports; particularly presence of gold standard elements; 2) evaluating the effects of varying supervision strategies on fidelity and client outcomes; and 3) testing the mediating effect of treatment fidelity on the relationship between supervision type and client outcomes. We propose a two-phased, within-subjects and between subjects design. In Phase I (9 months), we examined supervision with implementation support. In Phase II (30 months), we will examine two specific supervision conditions, each including varying EBP supervision elements.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98195
- Recruiting
- University of Washington Department of Psychology
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Contact:
- Kelly Thompson, MSW
- Phone Number: 206.616.5768
- Email: kelly3@u.washington.edu
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Contact:
- Shannon Dorsey, PhD
- Phone Number: 206-543-4527
- Email: dorsey2@u.washington.edu
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Principal Investigator:
- Shannon Dorsey, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children between the ages of 6-17 who are starting Trauma-focused Cognitive Behavioral Therapy (TF-CBT) with one of our enrolled clinicians.They must also have significant Post Traumatic Stress symptoms as measured by a score of 21 or higher on the UCLA PTSD-RI, and live with a parent or guardian who is willing to participate in the study.
- Community-based mental health clinicians who are employed in Regional Support Network agencies (state Medicaid clinics) who have participated in the Washington State Initiative for TF-CBT and are supervised by a participating supervisor, or have completed the TF-CBT web training and been supervised on a case.
- Community-based mental health supervisors trained in the WA State Initiative in TF-CBT and employed at participating clinics in WA.
Exclusion Criteria:
- Non-English speaking child.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Symptom and Fidelity Monitoring (SFM)
Half of the study clinicians will be randomized to this supervision condition of TF-CBT.
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Supervisors will be trained in one of two supervision strategies: Symptom and Fidelity Monitoring (SFM) or Symptom and Fidelity Monitoring + Behavioral Rehearsal (SFM + BR)
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EXPERIMENTAL: SFM + Behavioral Rehearsal
Half of the study clinicians will be randomized to this supervision condition of TF-CBT.
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Supervisors will be trained in one of two supervision strategies: Symptom and Fidelity Monitoring (SFM) or Symptom and Fidelity Monitoring + Behavioral Rehearsal (SFM + BR)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Coding Therapy Sessions to Assess Clinician Fidelity to TF-CBT Strategy.
Time Frame: 2 years
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Evidence-Based Practices such as Trauma-focused Cognitive Behavioral Therapy (TF-CBT) usually include ongoing supervision to assess how true (e.g. fidelity) clinicians stay to their training in the specific treatment. We will be coding therapy audio recordings using an adapted TF-CBT Therapy Process Observational Coding System for Children (TF-CBT TPOCS-S) scoring manual. We will also use clinician self-report of fidelity using the Washington State Evidence Based Practice (EBP) Toolkit, and supervisor-report of fidelity in the EBP Toolkit. We will ultimately be assessing how fidelity serves as a mediator for the relationship between supervision condition and client outcomes. |
2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Client outcomes for Post-Traumatic Stress and overall functioning
Time Frame: 6 months
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We will complete phone interviews with children and guardians to assess the client outcomes at baseline, 3 months post-baseline, and 6 months post-baseline.
We will use the UCLA Post Traumatic Stress Disorder Reaction Index (PTSD RI) to assess trauma exposure and post-traumatic stress symptoms.
We will use the Strengths and Difficulties Questionnaire (SDQ), a short behavioral screening survey, to assess overall functioning.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Kelly Thompson, MSW, University of Washington
Publications and helpful links
General Publications
- Dorsey S, Kerns SEU, Lucid L, Pullmann MD, Harrison JP, Berliner L, Thompson K, Deblinger E. Objective coding of content and techniques in workplace-based supervision of an EBT in public mental health. Implement Sci. 2018 Jan 24;13(1):19. doi: 10.1186/s13012-017-0708-3.
- Dorsey S, Pullmann MD, Deblinger E, Berliner L, Kerns SE, Thompson K, Unutzer J, Weisz JR, Garland AF. Improving practice in community-based settings: a randomized trial of supervision - study protocol. Implement Sci. 2013 Aug 10;8:89. doi: 10.1186/1748-5908-8-89.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- A64442
- R01MH095749 (NIH)
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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