NCT01796158

Brief Summary

The goal of this project is to conduct a pilot study evaluating feasibility, acceptability, and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescent primary care patients.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 20, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

2.5 years

First QC Date

February 20, 2013

Last Update Submit

October 6, 2016

Conditions

Keywords

adolescentsalcohol abusedrug abusesubstance use

Outcome Measures

Primary Outcomes (1)

  • cMET completion

    The investigators will measure the percentages of completed cMET sessions by those referred to cMET.

    Baseline

Secondary Outcomes (1)

  • cMET satisfaction

    9 months

Other Outcomes (1)

  • Alcohol use

    9 months

Study Arms (2)

cASBI+cMET

EXPERIMENTAL

Participants will complete the computerized alcohol screening and brief intervention (cASBI)protocol at the time of an office visit and also complete the 2-session computerized Motivational Enhancement Therapy intervention (cMET).

Behavioral: cASBI+cMETBehavioral: cASBI

cASBI

ACTIVE COMPARATOR

Participants will complete the computerized screening and brief intervention protocol at the time of a primary care office visit.

Behavioral: cASBI

Interventions

cASBI+cMETBEHAVIORAL

In the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit. The cMET protocol is a 2 session intervention composed of 8 exercises designed to encourage adolescents their alcohol and other substance use and develop a plan to stop or reduce their use.

cASBI+cMET
cASBIBEHAVIORAL

In the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit.

cASBIcASBI+cMET

Eligibility Criteria

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

You may qualify if:

  • any alcohol use days in the past 90 days
  • have an email address and internet access at home, school, or library

You may not qualify if:

  • unable to read or understand English
  • living away at college at the time of the recruitment visit
  • not available for computer/telephone follow-ups
  • judged by the provider to be medically or emotionally unstable at time of visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 21, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 7, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations