- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05489068
Motivational Interviewing at Intake vs Intake as Usual on Client Engagement in Addiction Treatment
May 8, 2023 updated by: University of New Mexico
Adapting Intake Procedures to Improve Treatment Delivery in Addiction Treatment
This K23 study is an effectiveness-implementation hybrid type I design to determine the effectiveness of Motivational Interviewing at Intake (MII), relative to intake-as-usual on client engagement and mechanisms of engagement among adults seeking outpatient addiction treatment.
We also will obtain personnel feedback on the feasibility of implementing MII into standard practice by having personnel from the addiction treatment study sites complete implementation climate measures before Motivational Interviewing (MI) training and post-clinical trial, as well as an individual interview on implementation feasibility post-trial.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
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: Margo Hurlocker, PhD
- Phone Number: (505) 596-0578
- Email: mhurlocker@unm.edu
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87111
- Recruiting
- Turning Point Recovery Center
-
Contact:
- Alaina Geoff
- Phone Number: 505-217-1717
- Email: alaina@turningpointrc.com
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria (client participants):
- English-speaking adults seeking treatment for alcohol or other drug use at one of two outpatient addiction treatment programs
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures
- Physically withdrawn from alcohol or other drugs
Inclusion Criteria (personnel participants):
- English-speaking adults currently employed at one of the two outpatient addiction treatment programs
- Provision of electronic informed consent
Exclusion Criteria (client participants):
- Experiencing severe withdrawal symptoms
- Actively psychotic, manic, and/or suicidal
Exclusion Criteria (personnel participants):
- current position: facility owner or clinical director
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motivational Interviewing at Intake (MII)
Clients allocated to the MII condition will receive a 90-minute pure Motivational Interviewing (MI) session.
|
The MII will involve a goal-oriented and collaborative conversation about why the client wants treatment now, and how treatment might fit with his/her most important values.
The provider will use open questions, reflective listening and autonomy support in a flexible, non-authoritative manner.
Rather than asking specific questions in different life domains, the provider will explore with the client their desires, abilities, reasons, and needs for treatment, how treatment fits with their values, and what successful treatment looks like to them.
The client's language about change will be strategically reinforced to increase its frequency and strength across the session.
|
Active Comparator: Intake as Usual (IAU)
Clients allocated to the IAU condition will receive the 90-minute standard assessment that is delivered to all clients entering intensive outpatient program (IOP)/outpatient program (OP).
|
In line with the American Society of Addiction Medicine (ASAM) guidelines, the IAU condition involves a semi-structured interview of the client's psychosocial history and clients answer a series of questions in the following domains: support system, living situation, educational, occupational, family, and medical history.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who attended the first outpatient treatment program session based on electronic medical record review
Time Frame: up to 36 weeks
|
Treatment entry is determined by review of electronic medical record of whether clients attended their first scheduled treatment session
|
up to 36 weeks
|
Number of treatment sessions attended during the three-month outpatient treatment program based on electronic medical record review
Time Frame: up to 36 weeks
|
Number of treatment sessions that clients attend is determined by review of electronic medical record and calculating number of treatment sessions attended.
|
up to 36 weeks
|
Number of participants who completed the three-month outpatient treatment program based on electronic medical record review
Time Frame: up to 36 weeks
|
Completion of the three-month outpatient treatment program is determined by review of electronic medical record
|
up to 36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in client readiness to enter treatment on the University of Rhode Island Change Assessment Scale (URICA) at 1 hour post-intake
Time Frame: baseline and 1 hour post-intake
|
The URICA is a validated, self-report measure of client readiness for treatment engagement.
Possible scores range from 32 to 160 with higher scores indicative greater readiness to enter treatment.
Change = (Hour 1 score - Baseline Score).
|
baseline and 1 hour post-intake
|
Score on therapeutic alliance on the Working Alliance Inventory (WAI) at 1-hour post-intake
Time Frame: 1 hour post-intake
|
The WAI is a validated, self-report measure of client perceptions of the therapeutic process by assessing three sub scales: Goals, Bond, and Tasks.
Possible scores on sub scales range from 12 to 84 with higher scores indicative of better therapeutic alliance.
|
1 hour post-intake
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in organizational readiness to change on the Texas Christian University-Organizational Readiness to Change (TCU-ORC) at 1 year
Time Frame: baseline and 1 year
|
The TCU-ORC is a validated, self-report measure of personnel perceptions of their organization's readiness and willingness to make changes.
Possible scores range from 125 to 625 with higher scores indicative of more readiness to change.
Change = (Year 1 score - Baseline Score).
|
baseline and 1 year
|
Change from baseline in organizational readiness to change on the Readiness for Organizational Change (ROC) at 1 year
Time Frame: baseline and 1 year
|
The ROC is a validated, self-report measure of personnel perceptions of their organization's readiness to change.
Possible scores range from 25 to 155 with higher scores indicative of more readiness to change.
Change = (Year 1 score - Baseline Score).
|
baseline and 1 year
|
Change from baseline in organizational capability to change on the Change Process Capability Questionnaire (CPCQ) at Year 1
Time Frame: baseline and 1 year
|
The CPCQ is a validated, self-report measure of personnel perceptions of of their organization's capability to change.
Possible scores range from 1 to 132 with higher scores indicative of more capability to make changes in the organization.
Change = (Year 1 score - Baseline Score).
|
baseline and 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Margo Hurlocker, PhD, University of New Mexico
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)
March 16, 2022
Primary Completion (Anticipated)
October 1, 2024
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
July 26, 2022
First Submitted That Met QC Criteria
August 2, 2022
First Posted (Actual)
August 5, 2022
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A22-0014
- K23DA052646 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie results reported in a peer-reviewed publication, after deidentification (text, tables, figures, and appendices).
Session audio recordings will not be shared.
IPD Sharing Time Frame
Data will become available starting in January 2025
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal will have access to the data.
A data use agreement will be required, signed by the requesting investigator and their Authorized Organization Representation (AOR)/Signing Official (SO)
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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