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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01796158
Other study ID # JKR34_PA-13-078
Secondary ID
Status Withdrawn
Phase N/A
First received February 20, 2013
Last updated October 6, 2016
Start date September 2013
Est. completion date March 2016

Study information

Verified date October 2016
Source Boston Children’s Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

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. The investigators hypothesize that 1) cMET, when added to Computerized Alcohol Screening and Brief Intervention (cASBI), (cASBI+cMET) will be feasible and acceptable when used in primary care; and 2) 12- to 18-yr old patients receiving cASBI+cMET will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, than cASBI alone.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria:

- any alcohol use days in the past 90 days

- have an email address and internet access at home, school, or library

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
cASBI+cMET
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
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.

Locations

Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Alcohol use The investigators will measure rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking in the cASBI+cMET group vs the cASBI group. 9 months No
Primary cMET completion The investigators will measure the percentages of completed cMET sessions by those referred to cMET. Baseline No
Secondary cMET satisfaction The investigators will measure patient satisfaction with the cMET program. 9 months No
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