- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02083523
Project CHOICE: Efficacy Testing of CHOICE and CHOICE+Normative Feedback Interventions (CHOICE)
March 10, 2014 updated by: Douglas Smith, University of Illinois at Urbana-Champaign
PROJECT CHOICE: Efficacy Testing of Motivational Interviewing (MI) for Adolescents Referred for Substance Use Concerns
This study will use a pilot test format to examine the efficacy of a brief Motivational Interviewing (MI) intervention developed by the investigator Dr. Douglas Smith called CHOICE (Compassionate Helpers Openly Inviting Client Empowerment)with youth referred for substance abuse assessments to substance abuse treatment agencies in Chicago and Urbana, IL.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will use a pilot test format to examine the efficacy of a brief Motivational Interviewing (MI) intervention developed by the investigator Dr. Douglas Smith called CHOICE (Compassionate Helpers Openly Inviting Client Empowerment)with youth referred for substance abuse assessments to substance abuse treatment agencies in Chicago and Urbana, IL.
The study will have two arms: one group will receive the standard CHOICE Motivational Interview (MI) while the second group will receive the CHOICE Motivational Interview with a Normative Feedback component, called CHOICE+ (CHOICE Plus).
The hypothesis is that there will be no difference in outcomes between those that receive the standard CHOICE and those that receive the CHOICE+ MI.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
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
13 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Youth 13-19 years of age (and their parents or legal guardians if their youth has been referred for an assessment with the Prairie Center counseling staff.)
- referred for an assessment to see if they need substance use disorder treatment
- have used substances on 13 or more days out of the past 90 days or scored higher than 2 on the CRAFT assessment. -
Exclusion Criteria:
- Low cognitive functioning
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Motivational Interview
The Motivational Interview, or MI, (15-30 minutes) was provided after initial substance use disorder assessments but prior to treatment admission.
I twas facilitated by a computer generated report and included: an orientation to the session, discussion of the participants' strengths, an agenda setting procedure, a review of concerns, and a session summary.
Therapists conveyed empathy, used reflective listening, tried to elicit and reinforce change talk elements, and elicited action steps from the participants.
|
The Motivational Interview (MI) addresses ambivalence about change.
It's effects are mediated by how well counselors evoke change talk, or in-session client utterances about the: need for; commitment to; ability to; or steps needed, to change.
Other Names:
|
|
Active Comparator: MI with Normative Feedback
The Motivational Interview with Normative Feedback, or MI + NF, condition/intervention included all procedures described for the MI condition.
Additionally, in the MI + NF condition/intervention, the participants' days of marijuana and alcohol use were compared to two sets of norms ( age specific or level of care specific) available for treatment attending youth.
Therapists used whichever norm provided a greater contrast with participants' use.
|
NOrmative Feedback (NF) contrasts and individual's substance use to available norms for one's reference group (i.e., descriptive norms.)
Essentially, NF highlights how an individual's behavior is non-normative, which in turn, is thought to lead to reduced substance use.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
% Readiness to Change
Time Frame: Day One
|
% Readiness to Change was measured immediately following receipt of the intervention session.
|
Day One
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Days of Substance Use Treatment
Time Frame: 3 months post intake
|
3 months post intake
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Substance Use Frequency
Time Frame: 3 months post intake
|
3 months post intake
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Douglas Smith, PhD, University of Illinois Urbana Champaign
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
March 1, 2013
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
January 9, 2014
First Submitted That Met QC Criteria
March 10, 2014
First Posted (Estimate)
March 11, 2014
Study Record Updates
Last Update Posted (Estimate)
March 11, 2014
Last Update Submitted That Met QC Criteria
March 10, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Smith13356
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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