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Reducing Problematic Substance Use in Youth With Chronic Medical Conditions

This study is not yet open for participant recruitment.
Verified January 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01709201
First received: October 15, 2012
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

The investigators goal is to pilot a substance use-related brief intervention (BI) for youth with chronic medical conditions, obtaining preliminary evidence of feasibility, acceptability and impacts of the approach for reducing substance use among this group.


Condition Intervention
Alcohol Abuse
Drug Abuse
 Behavioral: Brief Intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing Problematic Substance Use in Youth With Chronic Medical Conditions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Percent days abstinent [ Time Frame: 30 days post baseline ] [ Designated as safety issue: No ]
    We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 30 days post baseline


Secondary Outcome Measures:
  • Medical complications [ Time Frame: 30 days post baseline ] [ Designated as safety issue: No ]
    We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline


Other Outcome Measures:
  • Percent Days Abstinent 90 days post baseline [ Time Frame: 90 days post baseline ] [ Designated as safety issue: No ]
    We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 90 days post baseline

  • Medical complications 90 days post baseline [ Time Frame: 90 days post baseline ] [ Designated as safety issue: No ]
    We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline


Estimated Enrollment: 52
Study Start Date: July 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment as Usual
Those in the Treatment as Usual group will not receive the brief intervention for substance use but will receive a brief health education brochure.
Experimental: Brief Intervention
Those in the Brief Intervention group will receive a brief motivational intervention aimed at encouraging the participant to decrease their substance use.
 Behavioral: Brief Intervention
Those in the intervention arm will undergo a 10-minute discussion with a trained interventionist aimed at encouraging decreased substance use.

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 14-18 years old
  • Currently being treated for diabetes, rheumatologic disorders, asthma, or ulcerative colitis (UC) at Boston Children's Hospital with a duration of chronic illness of at least one year
  • Previous participation in the screening validation study
  • Evidence of problems related to substance use

Exclusion Criteria:

  • Medically or emotionally unstable or otherwise unable to provide assent/consent
  • Unable to speak/read English
  • Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709201

Contacts
Contact: Sharon Levy, MD 617-355-5433 sharon.levy@childrens.harvard.edu
Contact: Shari Van Hook, MPH 617-355-5433 shari.vanhook@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Sharon Levy, MD, MPH Boston Children's Hospital
Principal Investigator: Elissa Weitzman, ScD, MSc Boston Children's Hospital
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01709201     History of Changes
Other Study ID Numbers: FP01009751
Study First Received: October 15, 2012
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Alcohol abuse
Drug abuse
Diabetes Mellitus
 Persistent Asthma
Juvenile Arthritis
Ulcerative Colitis

Additional relevant MeSH terms:
Substance-Related Disorders
Alcoholism
Mental Disorders
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on May 16, 2013