CClinicalTrials.gg
WithdrawnNCT00891631Updated Oct 7, 2016

Primary Care iSBIRT to Reduce Serious Teen Health Risks

A Phase 1/2 interventional study of iSBIRT and iSBIRT/TE in Substance-related Disorders, Depression and High-risk Sex, sponsored by Boston Children's Hospital. Withdrawn at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2016-10-07.

Sponsored by Boston Children's Hospital · Phase 1/2, Interventional, and Screening

Why this study was withdrawn
Grant application was not funded
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
12 Years to 21 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Substance-related Disorders
  • Depression
  • High-risk Sex

Keywords

  • tobacco
  • alcohol
  • marijuana
  • drug use
  • seat-belt
  • weapons
  • depression
  • suicidality
  • sexual risk behaviors
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

Browse Substance-Related Disorders studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • less than 6th grade reading level
  • unavailable for follow-up questionnaires
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    iSBIRT

    Participants will complete the iSBIRT system.

    Behavioral: iSBIRT

  • Experimental
    iSBIRT/TE

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

    Behavioral: iSBIRT/TE

  • No intervention
    TAU

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

Interventions

  • BehavioraliSBIRT

    Participants will receive the internet/intranet based screening, brief intervention, and referral to treatment program.

    Also known as: SBIRT

  • BehavioraliSBIRT/TE

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

    Also known as: SBIRT

06

What researchers measure

Primary outcomes

  1. frequency of substance use and other risk behaviors

    Time frame: 3 months

07

Study locations

1 site
  • Children's Hospital Boston
    Boston, Massachusetts 02115, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00891631
Lead sponsor
Boston Children's Hospital
Responsible party
John R Knight, MD (Associate Professor of Pediatrics, Harvard Medical School; Senior Associate in Medicine; Associate in Psychiatry, Director, Center for Adolescent Substance Abuse Research, Boston Children's Hospital, Boston Children's Hospital) — Principal investigator
First posted
May 1, 2009
Start date
Sep 2009
Primary completion
Sep 2011 (estimated)
Completion
Sep 2011 (estimated)
Last update
Oct 7, 2016

Study contacts

John R Knight, MD
principal investigator · Boston Children's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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