NCT01922947

Brief Summary

The purpose of this research is to test the feasibility and efficacy of a brief (one session) preventative intervention using motivational interviewing integrated with social network counseling for substance use among adolescent patients in a primary care setting. One hundred participants will be randomly assigned to either motivational interviewing integrated with social network counseling or attention control conditions. The motivational interviewing integrated with social network counseling condition is expected to show improvement when compared to the attention control condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration 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

Study Start

First participant enrolled

August 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2014

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

2.3 years

First QC Date

July 23, 2013

Last Update Submit

June 9, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effects of counseling on substance use factors in teens

    To assess the efficacy of motivational interviewing integrated with social network counseling compared to an attention control condition on substance use factors in teens assessed via self-report questionnaires at baseline, 1, 3, and 6 months.

    Feb. 2015

Study Arms (2)

Motivational Interviewing w/Social Network Counseling

ACTIVE COMPARATOR

Motivational Interviewing integrated with Social Network Counseling, 20-minute session.

Behavioral: Active Control Condition

Health Counseling

SHAM COMPARATOR
Behavioral: Motivational Interviewing w/Social Network Counseling

Interventions

This is the active arm of the study.

Health Counseling

20-minute health counseling

Motivational Interviewing w/Social Network Counseling

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old
  • Resident of Richmond VA or greater Richmond area
  • Patient at Virginia Commonwealth University or Richmond City Department of Health

You may not qualify if:

  • Ward of the state
  • Not fluent in English
  • Incapable of providing consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Michael P Mason, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2013

First Posted

August 14, 2013

Study Start

August 1, 2012

Primary Completion

November 30, 2014

Study Completion

November 30, 2014

Last Updated

June 12, 2017

Record last verified: 2017-06

Locations