Back to resultsReducing Problematic Substance Use in Youth With Chronic Medical Conditions
Primary Purpose
Alcohol Abuse, Drug Abuse
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Abuse focused on measuring Alcohol abuse, Drug abuse, Diabetes Mellitus, Persistent Asthma, Juvenile Arthritis, Ulcerative Colitis
Eligibility 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
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment as Usual
Brief Intervention
Arm Description
Those in the Treatment as Usual group will not receive the brief intervention for substance use but will receive a brief health education brochure.
Those in the Brief Intervention group will receive a brief motivational intervention aimed at encouraging the participant to decrease their substance use.
Outcomes
Primary Outcome Measures
Percent days abstinent
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
We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline
Full Information
NCT ID
NCT01709201
First Posted
October 15, 2012
Last Updated
June 19, 2017
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01709201
Brief Title
Reducing Problematic Substance Use in Youth With Chronic Medical Conditions
Official Title
Reducing Problematic Substance Use in Youth With Chronic Medical Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study did not receive funding and was administratively withdrawn.
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Drug Abuse
Keywords
Alcohol abuse, Drug abuse, Diabetes Mellitus, Persistent Asthma, Juvenile Arthritis, Ulcerative Colitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Those in the Treatment as Usual group will not receive the brief intervention for substance use but will receive a brief health education brochure.
Arm Title
Brief Intervention
Arm Type
Experimental
Arm Description
Those in the Brief Intervention group will receive a brief motivational intervention aimed at encouraging the participant to decrease their substance use.
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention
Intervention Description
Those in the intervention arm will undergo a 10-minute discussion with a trained interventionist aimed at encouraging decreased substance use.
Primary Outcome Measure Information:
Title
Percent days abstinent
Description
We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 30 days post baseline
Time Frame
30 days post baseline
Secondary Outcome Measure Information:
Title
Medical complications
Description
We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline
Time Frame
30 days post baseline
Other Pre-specified Outcome Measures:
Title
Percent Days Abstinent 90 days post baseline
Description
We will compare the percent days abstinent from substances between the Treatment as Usual and Intervention groups 90 days post baseline
Time Frame
90 days post baseline
Title
Medical complications 90 days post baseline
Description
We will evaluate the incidents of disease complications between the Treatment as Usual and Intervention groups 30 days post baseline
Time Frame
90 days post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Levy, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elissa Weitzman, ScD, MSc
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
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Reducing Problematic Substance Use in Youth With Chronic Medical Conditions
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