Reducing Problematic Substance Use in Youth With Chronic Medical Conditions

June 19, 2017 updated by: Sharon Levy, Boston Children's Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days post baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
90 days post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimate)

October 18, 2012

Study Record Updates

Last Update Posted (Actual)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP01009751

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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