- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01454206
Integration of (iSBIRT) for Teen Drug Use Into a Pediatric Network
October 6, 2016 updated by: John R Knight, MD, Boston Children's Hospital
Integration of Internet-facilitated Screening, Brief Intervention, Referral to Treatment (iSBIRT) for Teen Drug Use Into a Pediatric Network
The Goal of this project is to integrate a previously-tested internet-facilitated Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescent substance use into a large network of primary care offices, the Pediatric Practices of Children's Hospital Boston (PPOC).
Study Overview
Study Type
Interventional
Phase
- Phase 2
- Phase 3
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
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
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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
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 12-18 year olds
- Coming for non-emergent care
- Access to a private computer
- Have email address
Exclusion Criteria:
- Not available for follow-up questionnaires
- Unable to read or understand English at a 6th grade reading level
- Medically or emotionally unstable on the day of the visit
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Treatment as Usual
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Experimental: iSBIRT
Participants will receive the internet-facilitated screening, brief intervention and referral to treatment (iSBIRT intervention)
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Participants will be screened for substance use, view information about the health effects of substance use on the computer, and receive advice from the primary care provider regarding the health effects of substance use.
Those found to be at "high risk" will complete an internet-based program encouraging them to change their substance use.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Provider attitude toward iSBIRT
Time Frame: 12 months post baseline
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We will evaluate providers' acceptance of and attitude toward integrating iSBIRT into their practices.
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12 months post baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Youth connectedness to provider
Time Frame: Baseline
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We will measure adolescents' attitudes toward their providers' advice regarding the health effects of substance use given during the visit
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Baseline
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iSBIRT sustainability
Time Frame: 12 months post
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We will measure rates of continued use of iSBIRT by practices 12 months after iSBIRT recruitment and implementation ends
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12 months post
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Change in rates of adolescent substance use
Time Frame: 3 months post baseline
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We will measure the change in rates of adolescent substance use from baseline to 3 months post study visit.
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3 months post baseline
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Change in rates of adolescent substance use
Time Frame: 6 months post baseline
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We will measure the change in rates of adolescent substance use from baseline to 6 months post study visit.
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6 months post baseline
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Change in rates of adolescent substance use
Time Frame: 12 months post baseline
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We will measure the change in rates of adolescent substance use from baseline to 12 months post study visit.
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12 months post baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John R Knight, MD, Boston Children's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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, 2012
Primary Completion (Anticipated)
October 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
October 5, 2011
First Submitted That Met QC Criteria
October 14, 2011
First Posted (Estimate)
October 18, 2011
Study Record Updates
Last Update Posted (Estimate)
October 7, 2016
Last Update Submitted That Met QC Criteria
October 6, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CeASAR app RFADA12008
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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