Post Traumatic StressSTEPSNCT01800266
Randomized Controlled Trial of Supervision Strategies to Improve Clinician Fidelity to Trauma-focused CBT
A study testing Supervision Practices of TF-CBT in people with Post Traumatic Stress and Overall Functioning, run by University of Washington at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Post Traumatic Stress, Overall Functioning, Clinician Fidelity
- What is being tested?
- Supervision Practices of TF-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,280 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Mar 2017
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Non-English speaking child.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington Department of Psychology
Seattle, Washington, 98195
Shannon Dorsey, PhD, 206-543-4527, dorsey2@u.washington.edu
Kelly Thompson, MSW, 206.616.5768, kelly3@u.washington.edu
About this study
Official title: 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.
- Being tested
- Supervision Practices of TF-CBT
- Keywords
- Supervision, Implementation, Community Based Mental Health Services, Trauma Focused Cognitive Behavioral Therapy, Skill Building and Behavioral Rehearsal, Symptom and Fidelity Monitoring, Children, Adolescents
- Medical subject headings
- Assessment of Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervision Practices of TF-CBTBehavioural
Supervisors will be trained in one of two supervision strategies: Symptom and Fidelity Monitoring (SFM) or Symptom and Fidelity Monitoring + Behavioral Rehearsal (SFM + BR)
| Study group | Role | What they receive |
|---|---|---|
| Symptom and Fidelity Monitoring (SFM) | Experimental | Half of the study clinicians will be randomized to this supervision condition of TF-CBT. Receives: Behavioral: Supervision Practices of TF-CBT |
| SFM + Behavioral Rehearsal | Experimental | Half of the study clinicians will be randomized to this supervision condition of TF-CBT. Receives: Behavioral: Supervision Practices of TF-CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coding Therapy Sessions to Assess Clinician Fidelity to TF-CBT Strategy.
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.
Measured: 2 years
Secondary outcomes (1)
Client outcomes for Post-Traumatic Stress and overall functioning
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startJul 2012
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic StressStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Medicine and Dentistry of New Jersey
- Responsible party
- Principal investigator, Shannon Dorsey, University of Washington
- Investigators
- Shannon Dorsey, PhD, Principal investigator, University of WashingtonKelly Thompson, MSW, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800266
- Sponsor's protocol ID
- A64442
- Other IDs
- R01MH095749
- Acronym
- STEPS
- Status last verified
- Apr 2015
- First submitted
- 22 Feb 2013
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dorsey S, AlRasheed R, Kerns SE, Meza RD, Triplett N, Deblinger E, Jungbluth N, Berliner L, Naithani L, Pullmann MD. A randomized controlled trial testing supervision strategies in community mental health. Implement Res Pract. 2025 May 23;6:26334895251330523. doi: 10.1177/26334895251330523. eCollection 2025 Jan-Dec.
PubMed 40416801Dorsey 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.
PubMed 29368656Dorsey 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.
PubMed 23937766
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Practice in Community-based Settings: A Randomized Trial of Supervision Strategies
- ClinicalTrials.gov ID
- NCT01800266
- Acronym / sponsor ID
- STEPS / A64442
- Keywords
- Supervision, Implementation, Community Based Mental Health Services, Trauma Focused Cognitive Behavioral Therapy, Skill Building and Behavioral Rehearsal, Symptom and Fidelity Monitoring, Children, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,280 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Medicine and Dentistry of New Jersey
- Study start
- Jul 2012
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptom and Fidelity Monitoring (SFM) | Experimental | Behavioral: Supervision Practices of TF-CBTHalf of the study clinicians will be randomized to this supervision condition of TF-CBT. |
| SFM + Behavioral Rehearsal | Experimental | Behavioral: Supervision Practices of TF-CBTHalf of the study clinicians will be randomized to this supervision condition of TF-CBT. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Non-English speaking child.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervision Practices of TF-CBTSupervisors will be trained in one of two supervision strategies: Symptom and Fidelity Monitoring (SFM) or Symptom and Fidelity Monitoring + Behavioral Rehearsal (SFM + BR) | Behavioural | SFM + Behavioral Rehearsal, Symptom and Fidelity Monitoring (SFM) |
Primary outcome
Coding Therapy Sessions to Assess Clinician Fidelity to TF-CBT Strategy.
Time frame: 2 years
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.
1 secondary outcome
Client outcomes for Post-Traumatic Stress and overall functioning
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
- Derived from this study: PubMed 40416801Dorsey S, AlRasheed R, Kerns SE, Meza RD, Triplett N, Deblinger E, Jungbluth N, Berliner L, Naithani L, Pullmann MD. A randomized controlled trial testing supervision strategies in community mental health. Implement Res Pract. 2025 May 23;6:26334895251330523. doi: 10.1177/26334895251330523. eCollection 2025 Jan-Dec.
- Derived from this study: PubMed 29368656Dorsey 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.
- Derived from this study: PubMed 23937766Dorsey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Dorsey, PhD principal investigator
University of Washington
Kelly Thompson, MSW study director
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervision Practices of TF-CBT in people with Post Traumatic Stress and Overall Functioning, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shannon Dorsey, PhD (206.543.4527, dorsey2@u.washington.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coding Therapy Sessions to Assess Clinician Fidelity to TF-CBT Strategy. (time frame: 2 years). 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 NCT01800266, which also lists 3 linked publications.
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 1 May 2015.