- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07262372
Supervision in Substance Use Disorder Treatment Programs
December 4, 2025 updated by: University of Arkansas
Supervision Strategy for Substance Use Disorder Treatment Programs: A Pilot Study
Substance use disorders such as opioid addiction affect millions of adults in the United States each year, but the delivery of high-quality, effective addiction services is disrupted by organizational issues such as counselor burnout and turnover.
Clinical supervisors are essential for supporting counselors in specialty addiction treatment programs, but few supervisors receive supervision-focused training.
This project seeks to develop and pilot an evidence-based supervision strategy that has a high potential to enhance supervision and result in improved counselors' well-being and performance and, in turn, to improve client outcomes.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Substance use disorders (SUDs) such as addiction to opioids, methamphetamines and alcohol are a significant burden in the US, affecting almost 50 million individuals annually.
Community specialty SUD treatment programs ("SUD programs") are a key type of SUD providers and while effective treatments for SUD exist, significant issues in the organization and delivery of SUD programs (e.g., burnout, turnover) undermine the delivery of high-quality services.
Clinical supervisors are centrally positioned to support SUD counselors (frontline clinical providers) and ensure high service quality.
For clinical supervisors to effectively support counselors, they need evidence-based supervision strategies.
Currently, supervisors in community SUD programs receive very little training, support, and direction for supervision, and thus their supervision practices are highly variable, raising concern about the effectiveness of clinical supervision as currently provided in these programs.
Evidence-based supervision strategies can help fill the gap, and evidence from child welfare settings shows they improve leadership, climate, and client outcomes.
Based on our preliminary formative work with SUD providers in Arkansas, a reinforcement-based supervision strategy developed for counselors was deemed acceptable and feasible in SUD programs, and had high perceived potential to improve supervision quality, counselor well-being and performance, and client outcomes.
Participants thought the structure and content of the strategy were a good fit for SUD settings.
However, for a supervision strategy to be supportive of the work they do, it needs to be developed to reflect the language, case examples, and organizational factors relevant to the SUD settings.
The goals of our study are to iteratively develop and refine a supervision strategy for SUD settings, and to pilot it in residential treatment programs using quality improvement and implementation science tools and approaches.
Aim 1 involves leveraging previous experience developing supervision strategies and partnering with SUD providers to develop and refine the supervision strategy for SUD.
Using the Evidence-Based Quality Improvement (EBQI) process, we will engage SUD partners in a series of collaborative meetings to review and discuss the supervision strategy and related study materials, and to make key decisions.
The output of this work will be a refined and optimized SUD supervision strategy.
Aim 2 involves conducting two pilot cycles with supervisors and counselors in a sample of SUD residential treatment programs to assess the feasibility and acceptability of the supervision strategy, examine its impact on key organizational, counselor, and client outcomes, and to document barriers and facilitators for its implementation and sustained use in routine practice.
This study will provide key information to inform planning and design of a future fully powered study to assess the effectiveness of the new supervision strategy in a large sample of SUD programs.
Study Type
Interventional
Enrollment (Estimated)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jure Baloh, PhD
- Phone Number: 501 526 6604
- Email: jbaloh@uams.edu
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- University of Arkansas for Medical Sciences
-
Contact:
- Jure Baloh, PhD
- Phone Number: 501-526-6604
- Email: jbaloh@uams.edu
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Serves as a supervisor (i.e., oversee work of counselors) or counselor (i.e., directly work with clients) at a substance use treatment facility/program
- Program/facility provides residential services
Exclusion Criteria:
- Supervisors contracted (not employed) by the facility
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
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supervision arm
Supervisors will be trained and coached in a new supervision strategy (FOCUS)
|
The FOCUS supervision strategy provides a strenghts-based model for supervision.
It is built around three core components: (1) Five pillars for effective supervision interactions, (2) practical skills that operationalize these principles, and (3) a set of experiential activities that provide foundational learnings for staff to practice the skills around real-life situations (from which future client-specific interventions can be built).
In this study, FOCUS is being tailored for SUD treatment settings.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Counselor self-efficacy
Time Frame: Every 6 months for 2 years
|
Self-reported survey response at the counselor level (Efficacy subscale on TCU ORC; 1-5 Likert scale, higher scores are better; Lehman WEK, Greener JM, Simpson DD.
Assessing organizational readiness for change.
J Subst Abuse Treat.
2002;22(4):197-209.
doi: 10.1016/S0740-5472(02)00233-7.)
|
Every 6 months for 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Supervisor fidelity to FOCUS
Time Frame: Monthly, 2 years
|
Expert rated fidelity to FOCUS at the supervisor level (measure to be developed as part of the study)
|
Monthly, 2 years
|
|
Counselor performance
Time Frame: Every 6 months, for 2 years
|
Supervisor ratings of counselor performance (based on annual performance evaluations in use at the facilities)
|
Every 6 months, for 2 years
|
|
Organizational performance/outcomes - turnover
Time Frame: Every 6 months, for 2 years
|
Objective measures of employee turnover rate (at program level)
|
Every 6 months, for 2 years
|
|
Organizational performance/outcomes - client treatment completion
Time Frame: Every 6 months, for 2 years
|
Objective measures of client treatment completion rate (at program level)
|
Every 6 months, for 2 years
|
|
Organizational performance/outcomes - client satisfaction
Time Frame: Every 6 months, for 2 years
|
Client-reported satisfaction levels (at program level; as routinely collected by programs)
|
Every 6 months, for 2 years
|
|
FOCUS acceptability
Time Frame: Every 6 months, for 2 years
|
Supervisor perceptions of acceptability (satisfaction, appeal) of FOCUS and related materials (Acceptability of Intervention Measure [AIM], 1-5 Likert scale, higher scores are better; Weiner BJ, Lewis CC, Stanick C, et al.
Psychometric assessment of three newly developed implementation outcome measures.
Implementation Science.
2017;12:1-12.
doi: 10.1186/s13012-017-0635-3.)
|
Every 6 months, for 2 years
|
|
FOCUS feasibility
Time Frame: Every 6 months, for 2 years
|
Supervisor perceptions of feasibility (ease of use, "do-ability") of FOCUS and related materials (Feasibility of Intervention Measure [FIM], 1-5 Likert scale, higher scores are better; Weiner BJ, Lewis CC, Stanick C, et al.
Psychometric assessment of three newly developed implementation outcome measures.
Implementation Science.
2017;12:1-12.
doi: 10.1186/s13012-017-0635-3.)
|
Every 6 months, for 2 years
|
|
Leadership - implementation leadership
Time Frame: Every 6 months, for 2 years
|
Counselor perceptions of supervisors' support for ESTs (Implementation Leadership Scale [ILS], 1-5 Likert scale, higher scores are better; Aarons GA, Ehrhart MG, Torres EM, Finn NK, Roesch SC.
Validation of the implementation leadership scale (ILS) in substance use disorder treatment organizations.
J Subst Abuse Treat.
2016;68:31-35.
doi: 10.1016/j.jsat.2016.05.004.)
|
Every 6 months, for 2 years
|
|
Leadership - clinical supervision
Time Frame: Every 6 months, for 2 years
|
Counselor perceptions of supervisor instrumental assistance (Clinical Supervision, 1-5 Likert scale, higher scores are better; Knudsen HK, Ducharme LJ, Roman PM.
Clinical supervision, emotional exhaustion, and turnover intention: A study of substance abuse treatment counselors in the clinical trials network of the national institute on drug abuse.
J Subst Abuse Treat.
2008;35(4):387-395.
doi: 10.1016/j.jsat.2008.02.003.)
|
Every 6 months, for 2 years
|
|
Organizational Social Context - implementation climate
Time Frame: Every 6 months, for 2 years
|
Supervisor and counselor shared perceptions of organizational expectations of, and support and reward for EST use (Implementation Climate Scale [ICS], 1-5 Likert scale, higher scores are better; Ehrhart MG, Torres EM, Hwang J, Sklar M, Aarons GA.
Validation of the implementation climate scale (ICS) in substance use disorder treatment organizations.
Substance abuse treatment, prevention, and policy.
2019;14(1):1-10.
doi: 10.1186/s13011-019-0222-5.)
|
Every 6 months, for 2 years
|
|
Organizational Social Context - organizational climate
Time Frame: Every 6 months, for 2 years
|
Supervisor and counselor shared perceptions of organizational environment (Mission, Cohesion, and Stress subscales from TCU ORC; and Effort subscale from the Patterson Organizational Climate Measure; 1-5 Likert scale, higher scores are better; responses will be aggregated across subscales for primary analyses; Lehman WEK, Greener JM, Simpson DD.
Assessing organizational readiness for change.
J Subst Abuse Treat.
2002;22(4):197-209.
and Patterson MG, West MA, Shackleton VJ, et al.
Validating the organizational climate measure: Links to managerial practices, productivity and innovation.
J Organ Behav.
2005;26(4):379-408.
doi: 10.1002/job.312.)
|
Every 6 months, for 2 years
|
|
Counselor functioning - burnout
Time Frame: Every 6 months, for 2 years
|
Counselor perceptions of being overextended and depleted of emotional and physical resources (Emotional Exhaustion on Maslach Burnout Inventory; 1-5 Likert scale, lower scores are better; Maslach C, Jackson SE.
The measurement of experienced burnout.
J Organ Behav.
1981;2(2):99-113.
doi: 10.1002/job.4030020205.)
|
Every 6 months, for 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
July 21, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
June 30, 2027
Study Registration Dates
First Submitted
November 12, 2025
First Submitted That Met QC Criteria
November 21, 2025
First Posted (Estimated)
December 3, 2025
Study Record Updates
Last Update Posted (Actual)
December 11, 2025
Last Update Submitted That Met QC Criteria
December 4, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 297361
- R34DA060419 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual data will include observational data on supervisor fidelity (expert ratings); survey data on leadership, organizational social context, and counselor functioning (self-reported by counselors and/or supervisors); and interview data with leadership, supervisors, and counselors based on semi-structured interview guides informed by the study conceptual model and implementation science framework.
IPD Sharing Time Frame
Estimated in 2027 (at study conclusion and submission of manuscripts); We will archive our data in NAHDAP (https://www.icpsr.umich.edu/web/pages/NAHDAP/)
following the Restricted-Use Data Deposit and Dissemination Procedures.
IPD Sharing Access Criteria
We will archive our data in NAHDAP following Restricted-Use Data Deposit and Dissemination Procedures.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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