Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01881841
Other study ID # JRKnightR34PA-13-078
Secondary ID
Status Recruiting
Phase N/A
First received June 18, 2013
Last updated April 18, 2017
Start date January 2015
Est. completion date August 2017

Study information

Verified date April 2017
Source Boston Children’s Hospital
Contact John R Knight, MD
Phone 617-355-5433
Email john.knight@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The study aims are to:

1. Assess cMET feasibility and acceptability and estimate its effect size on underage drinking. Hypothesis: Among 14- to 20-yr-old primary care patients, those receiving cMET will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, than those receiving treatment as usual.

2. Estimate effect sizes for tobacco, cannabis, and other drug use, and other substance-related risks and outcomes including substance-related driving/riding, and experience of substance-related problems.

3. Identify potential moderators and mediators of cMET's effect.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 14 Years to 20 Years
Eligibility Inclusion Criteria:

- 14- 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.

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 the time of the visit.

Study Design


Intervention

Behavioral:
cMET
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.

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 Heavy episodic drinking The study investigators will measure the occurrences of heavy episodic drinking in the past 90 days at 3-, 6-, and 9-months follow-up. up to 9-months follow-up
Primary 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 Drinks per drinking day The study investigators will measure the number of drinks per drinking day in the past 90 days at 3-, 6-, and 9-months follow-up up to 9-months follow-up
See also
  Status Clinical Trial Phase
Withdrawn NCT02432066 - Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions Phase 2
Completed NCT03960138 - Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Completed NCT04646668 - Comparative Abuse Liability Among African American and White Smokers N/A
Completed NCT02560324 - Effect of Ramelteon on Smoking Abstinence Phase 2
Completed NCT02347605 - Medicinal Nicotine for Preventing Cue Induced Craving N/A
Completed NCT01625767 - Tobacco Approach Avoidance Training for Adolescent Smokers-1 Phase 2
Completed NCT01570595 - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV Phase 1/Phase 2
Completed NCT01442753 - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth N/A
Completed NCT01428310 - Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke Phase 1
Terminated NCT01800500 - Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers N/A
Active, not recruiting NCT01539525 - Screening to Augment Referral to Treatment- Project START Phase 2
Completed NCT01337817 - A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers Phase 1
Completed NCT00967005 - N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers Phase 2
Active, not recruiting NCT00751660 - Screening Methods in Finding Lung Cancer Early in Current or Former Smokers N/A
Completed NCT00790569 - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking N/A
Completed NCT00664261 - Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking N/A
Completed NCT00158145 - Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2 Phase 2
Completed NCT00158158 - Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2 Phase 2/Phase 3
Completed NCT00218179 - Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1 N/A