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Motivational Interviewing at Intake vs Intake as Usual on Client Engagement in Addiction Treatment

Primary Purpose

Substance-Related Disorders, Treatment Adherence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing at Intake (MII)
Intake as Usual (IAU)
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance-Related Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Physically withdrawn from alcohol or other drugs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

Sites / Locations

  • Turning Point Recovery CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational Interviewing at Intake (MII)

Intake as Usual (IAU)

Arm Description

Clients allocated to the MII condition will receive a 90-minute pure Motivational Interviewing (MI) session.

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).

Outcomes

Primary Outcome Measures

Number of participants who attended the first outpatient treatment program session based on electronic medical record review
Treatment entry is determined by review of electronic medical record of whether clients attended their first scheduled treatment session
Number of treatment sessions attended during the three-month outpatient treatment program based on electronic medical record review
Number of treatment sessions that clients attend is determined by review of electronic medical record and calculating number of treatment sessions attended.
Number of participants who completed the three-month outpatient treatment program based on electronic medical record review
Completion of the three-month outpatient treatment program is determined by review of electronic medical record

Secondary Outcome Measures

Change from baseline in client readiness to enter treatment on the University of Rhode Island Change Assessment Scale (URICA) at 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).
Score on therapeutic alliance on the Working Alliance Inventory (WAI) at 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.

Full Information

First Posted
July 26, 2022
Last Updated
May 8, 2023
Sponsor
University of New Mexico
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05489068
Brief Title
Motivational Interviewing at Intake vs Intake as Usual on Client Engagement in Addiction Treatment
Official Title
Adapting Intake Procedures to Improve Treatment Delivery in Addiction Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Treatment Adherence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Effectiveness-Implementation Hybrid Type 1 Design
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interviewing at Intake (MII)
Arm Type
Experimental
Arm Description
Clients allocated to the MII condition will receive a 90-minute pure Motivational Interviewing (MI) session.
Arm Title
Intake as Usual (IAU)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing at Intake (MII)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intake as Usual (IAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants who attended the first outpatient treatment program session based on electronic medical record review
Description
Treatment entry is determined by review of electronic medical record of whether clients attended their first scheduled treatment session
Time Frame
up to 36 weeks
Title
Number of treatment sessions attended during the three-month outpatient treatment program based on electronic medical record review
Description
Number of treatment sessions that clients attend is determined by review of electronic medical record and calculating number of treatment sessions attended.
Time Frame
up to 36 weeks
Title
Number of participants who completed the three-month outpatient treatment program based on electronic medical record review
Description
Completion of the three-month outpatient treatment program is determined by review of electronic medical record
Time Frame
up to 36 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in client readiness to enter treatment on the University of Rhode Island Change Assessment Scale (URICA) at 1 hour post-intake
Description
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).
Time Frame
baseline and 1 hour post-intake
Title
Score on therapeutic alliance on the Working Alliance Inventory (WAI) at 1-hour post-intake
Description
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.
Time Frame
1 hour post-intake
Other Pre-specified Outcome Measures:
Title
Change from baseline in organizational readiness to change on the Texas Christian University-Organizational Readiness to Change (TCU-ORC) at 1 year
Description
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).
Time Frame
baseline and 1 year
Title
Change from baseline in organizational readiness to change on the Readiness for Organizational Change (ROC) at 1 year
Description
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).
Time Frame
baseline and 1 year
Title
Change from baseline in organizational capability to change on the Change Process Capability Questionnaire (CPCQ) at Year 1
Description
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).
Time Frame
baseline and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margo Hurlocker, PhD
Phone
(505) 596-0578
Email
mhurlocker@unm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margo Hurlocker, PhD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turning Point Recovery Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaina Geoff
Phone
505-217-1717
Email
alaina@turningpointrc.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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)

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Motivational Interviewing at Intake vs Intake as Usual on Client Engagement in Addiction Treatment

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