Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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
See also
  Status Clinical Trial Phase
Completed NCT03165942 - Neuroendocrine Response to Oral Alcohol Administration Phase 1
Recruiting NCT05343039 - Technology Enhanced Adolescent Mental Health (TEAM) N/A
Active, not recruiting NCT04070521 - EEG Monitoring in the Emergency Department
Completed NCT03169244 - Buproprion for Binge Drinking Phase 2
Recruiting NCT05246202 - Personalized Feedback Intervention for Latinx Drinkers With Anxiety N/A
Completed NCT05036499 - PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain N/A
Recruiting NCT04368416 - Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
Not yet recruiting NCT04557631 - Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol
Terminated NCT00890149 - Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults Phase 2
Completed NCT02179749 - Mifepristone Treatment of Alcohol Use Disorder Phase 2
Completed NCT02681406 - Smartphone Based Continuing Care for Alcohol N/A
Completed NCT02448134 - A Community-Based Strategy for Preventing Underage Drinking N/A
Withdrawn NCT01847300 - cSBI-M for Young Military Personnel N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Withdrawn NCT01511679 - Brain-imaging and Adolescent Neuroscience Consortium N/A
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Withdrawn NCT01275391 - cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use Phase 1/Phase 2
Active, not recruiting NCT01539525 - Screening to Augment Referral to Treatment- Project START Phase 2
Completed NCT01207258 - Brief Intervention for Problem Drinking and Partner Violence Phase 2
Completed NCT00907309 - Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use Phase 1/Phase 2