NCT00735956

Brief Summary

Purpose of the study: This is a pilot randomized controlled trial to identify methods of involving underage youth in interventions to reduce alcohol use through the primary health care system. The trial will compare the effectiveness of using an onsite behavioral health specialist for screening, intervention and referral with basic written information and staff recommendations typically provided in primary care offices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

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

August 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 23, 2010

Status Verified

August 1, 2010

Enrollment Period

5 months

First QC Date

August 13, 2008

Last Update Submit

August 19, 2010

Conditions

Alcohol Abuse

Keywords

ScreeningBrief Intervention

Outcome Measures

Primary Outcomes (1)

  • The trial will compare the effectiveness of using an onsite behavioral health specialist for screening, intervention and referral with basic written information and staff recommendations typically provided in primary care offices.

    Same day

Secondary Outcomes (1)

  • Assessments and early intervention of identifying alcohol abuse in minors.

    Same day

Interventions

CounselingBEHAVIORAL

Handouts, referrals and brief counseling sessions are given after determination of early alcohol abuse has been assessed.

Also known as: CRAFFT, Other Shared Items Proposal

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 12 through 20.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Counseling

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Robert L Hubbard, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 15, 2008

Study Start

September 1, 2008

Primary Completion

February 1, 2009

Study Completion

August 1, 2009

Last Updated

August 23, 2010

Record last verified: 2010-08

Locations

US(1)