- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01501318
Impact of Personalized Feedback Alone on Substance Use Behaviors
Brief Education to Reduce Health Care Consumers' Risky Substance Use Behaviors: How Brief is Brief?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Screening and brief intervention (SBIRT) generally involves universal screening for risky substance use behaviors in medical settings and the immediate provision of a 3-15 minute intervention to those found to be at risk. In this pilot study, the investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions in the field by comparing a brief coach directed intervention to a tailored report only group. The goal is to create a cost-effective and sustainable system that provides consumers with tailored information that will help them both initiate and sustain the lifestyle changes necessary for improving their overall health.
Hypothesis 1: In a medical setting, personalized feedback alone will be associated with a reduction in risky substance use behaviors.
Hypothesis 2: In a medical setting, personalized feedback alone will have the same impact on behavior as that information plus a brief coach education session on risky substance use behaviors..
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri Hospital ER
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Low level risky substance use
Exclusion Criteria:
- high substance use risk levels
- potential alcohol or drug addiction or dependence
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Personalized feedback plus education
Participants receive the personalized feedback report plus education.
This is the currently implemented service approach.Treatment as usual with participants receiving a personalized feedback report about the risks associated with their current substance use behaviors and a brief (5-15 minute) motivational interviewing based education session provided by a trained health coach.
|
Participants receive the personalized feedback report plus education.
This is the currently implemented service approach.
|
|
EXPERIMENTAL: Personalized feedback report alone
Provision of the personalized feedback report alone.
|
Participants receive the personalized feedback report but no additional education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Substance use behaviors and consequences
Time Frame: 1 month follow-up
|
Interview questionnaire includes items concerning substance use behaviors (e.g., the number of drinks in the last 7 days) and consequences {e.g., ''During the past month, how often have you failed to do what was normally expected of you because of your use of alcohol?'
|
1 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Substance use behavioral intentions
Time Frame: 1 month follow-up
|
Interview questionnaire that asks participants about their memory of the materials provided in the intervention, their motivation toward change, and their self-reported change efforts.
|
1 month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthew G Hile, PhD, Missouri Institute of Mental Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1200450
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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