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Reducing Problematic Substance Use in Youth With Chronic Medical Conditions

This study has been withdrawn prior to enrollment.
(Study did not receive funding and was administratively withdrawn.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01709201
First Posted: October 18, 2012
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sharon Levy, Boston Children's Hospital
  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: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing Problematic Substance Use in Youth With Chronic Medical Conditions

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

Primary Outcome Measures:
  • Percent days abstinent [ Time Frame: 30 days post baseline ]
    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 ]
    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 ]
    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 ]
    We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline


Enrollment: 0
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709201


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

Responsible Party: Sharon Levy, Assistant Professor of Pediatrics, Harvard Medical School, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT01709201     History of Changes
Other Study ID Numbers: FP01009751
First Submitted: October 15, 2012
First Posted: October 18, 2012
Last Update Posted: June 21, 2017
Last Verified: June 2017

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

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