NCT01501318

Brief Summary

The investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions for risky substance use behaviors by comparing a brief coach directed intervention to a tailored report only group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

December 23, 2011

Last Update Submit

September 29, 2016

Conditions

Keywords

SBIRTbrief interventionalcoholdrug abuse

Outcome Measures

Primary Outcomes (1)

  • Substance use behaviors and consequences

    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 Outcomes (1)

  • Substance use behavioral intentions

    1 month follow-up

Study Arms (2)

Personalized feedback plus education

ACTIVE COMPARATOR

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.

Behavioral: Personalized feedback report plus education

Personalized feedback report alone

EXPERIMENTAL

Provision of the personalized feedback report alone.

Behavioral: Personalized feedback report

Interventions

Participants receive the personalized feedback report but no additional education.

Personalized feedback report alone

Participants receive the personalized feedback report plus education. This is the currently implemented service approach.

Personalized feedback plus education

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low level risky substance use

You may not qualify if:

  • high substance use risk levels
  • potential alcohol or drug addiction or dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri Hospital ER

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Matthew G Hile, PhD

    Missouri Institute of Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2011

First Posted

December 29, 2011

Study Start

February 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

September 30, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations