Substance-related DisordersPhase 1CHOICENCT02083523
Project CHOICE: Efficacy Testing of CHOICE and CHOICE+Normative Feedback Interventions
A Phase 1 study testing Motivational Interview with Normative Feedback and Motivational Interview in people with Substance-related Disorders, run by University of Illinois at Urbana-Champaign.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Substance-related Disorders
- What is being tested?
- Motivational Interview with Normative Feedback and Motivational Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Aug 2013
- Phase
- Phase 1
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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. -
Who cannot join
- Low cognitive functioning
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance-related Disorders
- Being tested
- Motivational Interview with Normative Feedback, Motivational Interview
- Keywords
- Motivational Interview, normative feedback, adolescents
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interview with Normative FeedbackBehavioural
Also called CHOICE + (MI + NF)
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.
Motivational InterviewBehavioural
Also called CHOICE
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interview | Active comparator | 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. Receives: Behavioral: Motivational Interview |
| MI with Normative Feedback | Active comparator | 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. Receives: Behavioral: Motivational Interview with Normative Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Readiness to Change
% Readiness to Change was measured immediately following receipt of the intervention session.
Measured: Day One
Secondary outcomes (1)
Days of Substance Use Treatment
Measured: 3 months post intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Smith, University of Illinois at Urbana-Champaign
- Investigators
- Douglas Smith, PhD, Principal investigator, University of Illinois Urbana Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083523
- Sponsor's protocol ID
- Smith13356
- Acronym
- CHOICE
- Status last verified
- Mar 2014
- First submitted
- 9 Jan 2014
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROJECT CHOICE: Efficacy Testing of Motivational Interviewing (MI) for Adolescents Referred for Substance Use Concerns
- ClinicalTrials.gov ID
- NCT02083523
- Acronym / sponsor ID
- CHOICE / Smith13356
- Conditions
- Substance-related Disorders
- Keywords
- Motivational Interview, normative feedback, adolescents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interview | Active comparator | Behavioral: Motivational InterviewThe 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. |
| MI with Normative Feedback | Active comparator | Behavioral: Motivational Interview with Normative FeedbackThe 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. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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. -
Key exclusion criteria (1 listed)
- Low cognitive functioning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interview with Normative FeedbackAlso: CHOICE + (MI + NF)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. | Behavioural | MI with Normative Feedback |
| Motivational InterviewAlso: CHOICEThe 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. | Behavioural | Motivational Interview |
Primary outcome
% Readiness to Change
Time frame: Day One
% Readiness to Change was measured immediately following receipt of the intervention session.
1 secondary outcome
Days of Substance Use Treatment
Time frame: 3 months post intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Smith, PhD principal investigator
University of Illinois Urbana Champaign
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Motivational Interview with Normative Feedback and Motivational Interview in people with Substance-related Disorders, run by University of Illinois at Urbana-Champaign.
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 3 inclusion and 1 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 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
% Readiness to Change (time frame: Day One). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2014.