Back to resultsIntegration of (iSBIRT) for Teen Drug Use Into a Pediatric Network
Primary Purpose
Substance Use
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
iSBIRT
Sponsored by
About this trial
This is an interventional prevention trial for Substance Use focused on measuring cannabis abuse, alcohol abuse, substance abuse
Eligibility Criteria
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
Sites / Locations
- Children's Hospital Boston
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment as Usual
iSBIRT
Arm Description
Participants will receive the internet-facilitated screening, brief intervention and referral to treatment (iSBIRT intervention)
Outcomes
Primary Outcome Measures
Provider attitude toward iSBIRT
We will evaluate providers' acceptance of and attitude toward integrating iSBIRT into their practices.
Secondary Outcome Measures
Youth connectedness to provider
We will measure adolescents' attitudes toward their providers' advice regarding the health effects of substance use given during the visit
iSBIRT sustainability
We will measure rates of continued use of iSBIRT by practices 12 months after iSBIRT recruitment and implementation ends
Change in rates of adolescent substance use
We will measure the change in rates of adolescent substance use from baseline to 3 months post study visit.
Change in rates of adolescent substance use
We will measure the change in rates of adolescent substance use from baseline to 6 months post study visit.
Change in rates of adolescent substance use
We will measure the change in rates of adolescent substance use from baseline to 12 months post study visit.
Full Information
NCT ID
NCT01454206
First Posted
October 5, 2011
Last Updated
October 6, 2016
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01454206
Brief Title
Integration of (iSBIRT) for Teen Drug Use Into a Pediatric Network
Official Title
Integration of Internet-facilitated Screening, Brief Intervention, Referral to Treatment (iSBIRT) for Teen Drug Use Into a Pediatric Network
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The project was not funded
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
cannabis abuse, alcohol abuse, substance abuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Title
iSBIRT
Arm Type
Experimental
Arm Description
Participants will receive the internet-facilitated screening, brief intervention and referral to treatment (iSBIRT intervention)
Intervention Type
Behavioral
Intervention Name(s)
iSBIRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Provider attitude toward iSBIRT
Description
We will evaluate providers' acceptance of and attitude toward integrating iSBIRT into their practices.
Time Frame
12 months post baseline
Secondary Outcome Measure Information:
Title
Youth connectedness to provider
Description
We will measure adolescents' attitudes toward their providers' advice regarding the health effects of substance use given during the visit
Time Frame
Baseline
Title
iSBIRT sustainability
Description
We will measure rates of continued use of iSBIRT by practices 12 months after iSBIRT recruitment and implementation ends
Time Frame
12 months post
Title
Change in rates of adolescent substance use
Description
We will measure the change in rates of adolescent substance use from baseline to 3 months post study visit.
Time Frame
3 months post baseline
Title
Change in rates of adolescent substance use
Description
We will measure the change in rates of adolescent substance use from baseline to 6 months post study visit.
Time Frame
6 months post baseline
Title
Change in rates of adolescent substance use
Description
We will measure the change in rates of adolescent substance use from baseline to 12 months post study visit.
Time Frame
12 months post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Knight, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ceasar.org
Description
Center for Adolescent Substance Abuse Research at Children's Hospital Boston
Learn more about this trial
Integration of (iSBIRT) for Teen Drug Use Into a Pediatric Network
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