Primary Care iSBIRT to Reduce Serious Teen Health Risks | NCT00891631

Studies
Primary Care iSBIRT to Reduce Serious Teen Health Risks

NCT00891631

Sponsor

Boston Children's Hospital

Status

Withdrawn

Last Update Posted

Oct 7, 2016Estimated

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Substance-related Disorders
Depression
High-risk Sex

Interventions

iSBIRT
iSBIRT/TE

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Grant application was not funded

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Sep 2011Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Apr 30, 2009

First Submission Date that Met QC Criteria

Apr 30, 2009

First Posted Date

May 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2016

Last Update Posted Date

Oct 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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 HospitalPrincipal Investigator

Lead Sponsor

Boston Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iSBIRT	Experimental	Participants will complete the iSBIRT system.	Behavioral: iSBIRT
iSBIRT/TE	Experimental	Participants will receive the internet/intranet screening, brief intervention, and referral to treatment system and technological extenders	Behavioral: iSBIRT/TE
TAU	No Intervention	Participants will receive Treatment as Usual from their primary care provider.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iSBIRT	Behavioral	Participants will receive the internet/intranet based screening, brief intervention, and referral to treatment program.	iSBIRT

Measure	Description	Time Frame
frequency of substance use and other risk behaviors		3 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John R Knight, MD	Boston Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Boston		Boston	Massachusetts	02115	United States

References Module

Citations

Not provided

ID	Term
D019966	Substance-Related Disorders
D003863	Depression
D047568	Unsafe Sex
D002189	Marijuana Abuse
D059020	Suicidal Ideation

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior