NCT01881841

Brief Summary

The goal of this project is to evaluate the feasibility, acceptability, and effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescents in primary care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

2.6 years

First QC Date

June 18, 2013

Last Update Submit

April 18, 2017

Conditions

Keywords

Alcohol abuseSubstance useTobacco use disorderMotivational Enhancement TherapyAdolescents

Outcome Measures

Primary Outcomes (1)

  • Alcohol use

    The study investigators will measure the past 90 day alcohol use at 3-, 6-, and 9-months follow-up.

    up to 9-months follow-up

Secondary Outcomes (1)

  • Drinks per drinking day

    up to 9-months follow-up

Other Outcomes (1)

  • Heavy episodic drinking

    up to 9-months follow-up

Study Arms (2)

Treatment As Usual

NO INTERVENTION

Those randomized to Treatment as Usual (TAU) will not complete cMET but will receive standard treatment from the doctor.

cMET

EXPERIMENTAL

Those randomized to cMET will complete a 2-session computerized Motivational Enhancement Therapy (cMET) intervention.

Behavioral: cMET

Interventions

cMETBEHAVIORAL

Those in cMET complete the 2-session self-administered computerized intervention which includes 8 exercises designed to encourage adolescents to evaluate the impact of alcohol and other substance use on their health and well-being and consider changing their use.

Also known as: Computerized Motivational Enhancement Therapy intervention
cMET

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 20- yr-olds
  • arriving for routine care to one of our participating pediatric practices (Lexington Pediatrics, Lexington, MA; East Boston Community Health Center, Longwood Pediatrics, Tufts Medical Center Adolescent Clinic, Boston, MA; Cambridge Health Alliance Dept. of Pediatrics, Cambridge, MA)
  • any alcohol use days in the past 90 days,
  • have an email address and internet access at home, school, or library
  • provide informed assent/consent.

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 the time of the visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Links

MeSH Terms

Conditions

AlcoholismTobacco Use DisorderSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • John R Knight, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
  • Sion K Harris, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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
Assistant Professor of Pediatrics, Harvard Medical School; Co-Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 20, 2013

Study Start

January 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

April 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations