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Signs and SymptomsPhase 2/3NCT01586676

Effectiveness of Motivational Interviewing Supervision in Community Programs

A Phase 2/3 study testing SAU and MIA: STEP in people with Signs and Symptoms and Clinical Supervision, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

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

The virtual requirement that substance abuse programs use evidence-based treatments (EBT) has prompted the development of dissemination strategies to promote EBT technology transfer. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Signs and Symptoms, Clinical Supervision
What is being tested?
SAU and MIA: STEP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteUnited States
Study dates
Jan 2009to May 2014
Phase
Phase 2/3
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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age 18 or older who work at one of the 12 participating programs
  • willing to serve as study clinicians and learn the MI assessment intake
  • working at least 20 hours per week at the program
  • are not intending to give notice to their employer that they intend to leave the agency or are not scheduled for medical or family leave during the study period
  • willing to record clinical sessions for review by the MI expert and/or independent raters
  • willing to have supervision sessions recorded if randomized to MIA: STEP condition
Show all 11Show fewer
  • deemed capable by program administrative leadership to manage the responsibilities of being a clinician in a randomized trial
  • English-speaking
  • seeking non-opiate replacement outpatient treatment for any substance use problem and have used primary substance (alcohol or illicit drug) at least once in the prior 28 days
  • 18 years of age or older
  • willing to participate in the protocol (randomization to clinicians contact for follow-up assessments, MI session recording for supervisor and independent review)

Who cannot join

  • served as MI therapists in prior clinical trial studies.
  • received formal supervision in MI based on direct observation, session ratings, and related feedback and coaching.
  • trained as MI trainers through the Motivational Interviewing Network of Trainers (MINT).
  • For Clients
  • insufficiently medically or psychiatrically stable to participate in outpatient treatment.
  • highly unlikely to be reached for follow-up due to residential instability or imminent incarceration.
  • seeking detoxification only, opiate replacement treatment, or residential inpatient treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Connecticut Healthcare System

    West Haven, Connecticut, 06516

Other trials in United States

About this study

The virtual requirement that substance abuse programs use evidence-based treatments (EBT) has prompted the development of dissemination strategies to promote EBT technology transfer. Implementation research, clinical trial training methods, and clinician training studies suggest that clinical supervision that involves direct observation, fidelity rating-based feedback, and coaching of therapeutic skills is a promising dissemination approach. However, clinical supervision delivered within substance abuse programs by on-site supervisors has never been directly tested in a randomized controlled trial to determine the impact of supervision on both clinician EBT skills and client treatment outcomes.

Recent results from two NIDA CTN protocols testing the effectiveness of Motivational Interviewing (MI) have shown that community program clinicians can learn to deliver MI with fidelity when receiving MI supervision from their program supervisors after workshop training and that their implementation of MI early in treatment improves client retention and primary substance use outcomes. A MI supervision manual called MIA: STEP (Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency) was developed from these protocols and has begun to be widely distributed by NIDA in partnership with SAMHSA for community program use. The effectiveness of the MIA: STEP supervision approach is unknown.

This study will directly test the effectiveness of MIA: STEP supervision on clinician MI fidelity and on client outcomes by randomly assigning 60 clinicians and 420 substance-using outpatients from 11 community programs within Connecticut to one of two conditions in which clinicians in both conditions will deliver a 1-session MI intervention to clients as the enter treatment. The conditions are: 1) workshop training plus MIA: STEP supervision, and 2) workshop training alone with supervision-as-usual practices used at each program. This project will be the first randomized trial to examine the impact of clinical supervision in an empirically based treatment on both clinician and client outcomes. Moreover, because it will provide workshop training and supervision completely within the context of community programs and utilize in-house program supervisors, it will provide a rigorous evaluation of a feasible model for disseminating EBTs such as MI.

Being tested
SAU, MIA: STEP
Keywords
supervision, motivational interviewing, substance abuse, dissemination
Medical subject headings
Signs and Symptoms, Substance-Related Disorders

What participants receive

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

  • SAUBehavioural

    Supervision-as-usual

  • MIA: STEPBehavioural

    Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA: STEP

Study groups in NCT01586676
Study groupRoleWhat they receive
MIA: STEPExperimentalMotivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA: STEP)
Receives: Behavioral: MIA: STEP
Supervision-as-usualActive comparatorSupervision-as-usual consists of the typical clinical supervision services provided to clinicians by their supervisors in their community programs.
Receives: Behavioral: SAU

What is being measured

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

  1. client retention

    The main outcome for the client participant trial is program retention at 4-week and 12-week followups after having received a 1-session intake. Program retention is defined as the the percent days of program attendances (days attended/# days scheduled) and percent sessions attended (sessions attended/# sessions scheduled) verified by administrative record and interview with clinical staff

    Measured: 4-week and 12-week follow-up

Secondary outcomes (1)

  1. motivational interviewing adherence and competence

    Change in clinician participant motivational interviewing (MI) adherence and competence will be measured from baseline to a post-trial point and from baseline to a 16-week post-trial follow-up point. The timeframe for the trial phase for each clinician participant will vary depending on how long it takes to be assigned and deliver the MI-base intake to 7 client participants.

    Measured: baseline, post-trial and 16-weeks post-trial

Timeline

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

  1. First posted27 Apr 2012 (estimated)
  2. Study startJan 2009
  3. Primary completionSep 2013
  4. Study completionMay 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 2/3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01586676
Sponsor's protocol ID
DESPR DA023230
Other IDs
R01DA023230
Status last verified
Oct 2015
First submitted
25 Apr 2012
Last updated
11 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Martino S. Strategies for training counselors in evidence-based treatments. Addict Sci Clin Pract. 2010 Dec;5(2):30-9.

    PubMed 22002451

  • Olmstead TA, Abraham AJ, Martino S, Roman PM. Counselor training in several evidence-based psychosocial addiction treatments in private US substance abuse treatment centers. Drug Alcohol Depend. 2012 Jan 1;120(1-3):149-54. doi: 10.1016/j.drugalcdep.2011.07.017. Epub 2011 Aug 9.

    PubMed 21831536

  • Olmstead T, Carroll KM, Canning-Ball M, Martino S. Cost and cost-effectiveness of three strategies for training clinicians in motivational interviewing. Drug Alcohol Depend. 2011 Jul 1;116(1-3):195-202. doi: 10.1016/j.drugalcdep.2010.12.015. Epub 2011 Jan 31.

    PubMed 21277713

  • Martino S, Ball SA, Nich C, Canning-Ball M, Rounsaville BJ, Carroll KM. Teaching community program clinicians motivational interviewing using expert and train-the-trainer strategies. Addiction. 2011 Feb;106(2):428-41. doi: 10.1111/j.1360-0443.2010.03135.x. Epub 2010 Oct 6.

    PubMed 20925684

  • Martino S, Brigham GS, Higgins C, Gallon S, Freese TE, Albright LM, Hulsey EG, Krom L, Storti SA, Perl H, Nugent CD, Pintello D, Condon TP. Partnerships and pathways of dissemination: the National Institute on Drug Abuse-Substance Abuse and Mental Health Services Administration Blending Initiative in the Clinical Trials Network. J Subst Abuse Treat. 2010 Jun;38 Suppl 1(Suppl 1):S31-43. doi: 10.1016/j.jsat.2009.12.013.

    PubMed 20307793

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SAU and MIA: STEP in people with Signs and Symptoms and Clinical Supervision, run by National Institute on Drug Abuse (NIDA) 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 11 inclusion and 7 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: finished, as of the sponsor's last update on 11 Jan 2017. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

client retention (time frame: 4-week and 12-week follow-up). 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 NCT01586676, which also lists 5 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 11 Jan 2017.

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