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Primary Care iSBIRT to Reduce Serious Teen Health Risks

Primary Purpose

Substance-related Disorders, Depression, High-risk Sex

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
iSBIRT
iSBIRT/TE
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Substance-related Disorders focused on measuring tobacco, alcohol, marijuana, drug use, seat-belt, weapons, depression, suicidality, sexual risk behaviors

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 12-21 years old
  • arriving for non-urgent care
  • provide informed assent/consent

Exclusion Criteria:

  • less than 6th grade reading level
  • unavailable for follow-up questionnaires

Sites / Locations

  • Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

iSBIRT

iSBIRT/TE

TAU

Arm Description

Participants will complete the iSBIRT system.

Participants will receive the internet/intranet screening, brief intervention, and referral to treatment system and technological extenders

Participants will receive Treatment as Usual from their primary care provider.

Outcomes

Primary Outcome Measures

frequency of substance use and other risk behaviors

Secondary Outcome Measures

Full Information

First Posted
April 30, 2009
Last Updated
October 6, 2016
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00891631
Brief Title
Primary Care iSBIRT to Reduce Serious Teen Health Risks
Official Title
Primary Care Internet/Intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) System to Reduce Serious Teen Health Risks
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Grant application was not funded
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (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 the project is to develop and test an internet/intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) system for adolescents that targets a broad range of serious health-risks and problem behaviors.
Detailed Description
We have previously developed and tested a computerized substance use screening and feedback program for adolescents. We will expand this program to include other serious health risks, enhance the feedback and health risk information adolescents will receive on the computer, develop Technological Extenders to extend the effect of the intervention, develop a training video and protocol for providers, and pilot test the system among adolescents coming for non-urgent care at a variety of primary care sites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-related Disorders, Depression, High-risk Sex
Keywords
tobacco, alcohol, marijuana, drug use, seat-belt, weapons, depression, suicidality, sexual risk behaviors

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iSBIRT
Arm Type
Experimental
Arm Description
Participants will complete the iSBIRT system.
Arm Title
iSBIRT/TE
Arm Type
Experimental
Arm Description
Participants will receive the internet/intranet screening, brief intervention, and referral to treatment system and technological extenders
Arm Title
TAU
Arm Type
No Intervention
Arm Description
Participants will receive Treatment as Usual from their primary care provider.
Intervention Type
Behavioral
Intervention Name(s)
iSBIRT
Other Intervention Name(s)
SBIRT
Intervention Description
Participants will receive the internet/intranet based screening, brief intervention, and referral to treatment program.
Intervention Type
Behavioral
Intervention Name(s)
iSBIRT/TE
Other Intervention Name(s)
SBIRT
Intervention Description
Participants will receive the internet/intranet screening, brief intervention, and referral to treatment system along with technological extenders
Primary Outcome Measure Information:
Title
frequency of substance use and other risk behaviors
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 12-21 years old arriving for non-urgent care provide informed assent/consent Exclusion Criteria: less than 6th grade reading level unavailable for follow-up questionnaires
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

Plan to Share IPD
No
Links:
URL
http://www.ceasar.org
Description
Web site of the Center for Adolescent Substance Abuse Research at Children's Hospital Boston

Learn more about this trial

Primary Care iSBIRT to Reduce Serious Teen Health Risks

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