Primary Care iSBIRT to Reduce Serious Teen Health Risks

This study has been withdrawn prior to enrollment.
(Grant application was not funded)
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00891631
First received: April 30, 2009
Last updated: March 7, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Tobacco, Alcohol and Drug Use
Seat-belt and Bicycle/Sports Helmet Use
Weapon Carrying and Associating With Peers Who Carry Weapons
Depression and Suicidality
High Risk Sexual Behaviors
Behavioral: iSBIRT
Behavioral: iSBIRT/TE
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Primary Care Internet/Intranet-based Screening, Brief Intervention, and Referral to Treatment (iSBIRT) System to Reduce Serious Teen Health Risks

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • frequency of substance use and other risk behaviors [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 699
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: iSBIRT
Participants will complete the iSBIRT system.
Behavioral: iSBIRT
Participants will receive the internet/intranet based screening, brief intervention, and referral to treatment program.
Other Name: SBIRT
Experimental: iSBIRT/TE
Participants will receive the internet/intranet screening, brief intervention, and referral to treatment system and technological extenders
Behavioral: iSBIRT/TE
Participants will receive the internet/intranet screening, brief intervention, and referral to treatment system along with technological extenders
Other Name: SBIRT
No Intervention: TAU
Participants will receive Treatment as Usual from their primary care provider.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891631

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: John R Knight, MD Children's Hospital Boston
  More Information

Additional Information:
No publications provided

Responsible Party: John R. Knight, MD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00891631     History of Changes
Other Study ID Numbers: iSBIRT RFA-od-09-003
Study First Received: April 30, 2009
Last Updated: March 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
tobacco
alcohol
marijuana
drug use
seat-belt
weapons
depression
suicidality
sexual risk behaviors

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014