Computerized Screening and Brief Physician Advice to Redu... | NCT00849589

Studies
Computerized Screening and Brief Physician Advice to Reduce Teen Drinking

NCT00849589

Sponsor

Boston Children's Hospital

Status

Withdrawn

Last Update Posted

Oct 7, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Alcohol Abuse
Risk Behavior

Interventions

Computerized screening and brief physician advice
Computerized SBA with technological extenders

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Withdrawn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

Jan 2010

Primary Completion Date

Jan 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Feb 23, 2009

First Submission Date that Met QC Criteria

Feb 23, 2009

First Posted Date

Feb 24, 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

Name	Class
Cambridge Health Alliance	OTHER
Dartmouth-Hitchcock Medical Center	OTHER
Fallon Clinic	INDUSTRY
Tufts Medical Center

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 this project is to adapt a computerized Screening and Brief Advice (SBA) protocol that has demonstrated efficacy in reducing underage drinking among adolescent primary care patients and then to test it in a multi-site randomized controlled trial (RCT).

Detailed Description

The specific aims of the proposed multisite RCT are:

To establish the efficacy of the computerized SBA protocol on alcohol use, on DWI/RWID, and other alcohol-related health risk behaviors;
To test the effect of Technological Extenders (TE) on prolonging the beneficial effects of the SBA protocol;
To identify moderators, mediators, and optimal responders to the SBA/TE interventions;
To examine the association between cessation of underage drinking and other health-risk behaviors in an adolescent primary care sample.

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

Not Applicable

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
1	No Intervention	Treatment as Usual (TAU)
2	Experimental	Computerized Screening and Brief Physician Advice (SBA)	Behavioral: Computerized screening and brief physician advice
3	Experimental	Computerized screening and brief physician advice with technological extenders (SBA/TE)	Behavioral: Computerized SBA with technological extenders

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computerized screening and brief physician advice	Behavioral	Participants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Initiation of underage drinking		Baseline, 3-months, 6-months, 12-months

Secondary Outcomes

Measure	Description	Time Frame
Cessation of underage drinking		Baseline, 3-months, 6-months, 12-months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

12-21 years old
patients arriving for routine medical care
provide informed assent (for those <18) or informed consent (for those 18-21)

Exclusion Criteria:

medically or psychologically unstable at time of visit
receiving behavioral health services
cannot read or understand English at a 6th grade reading level
unavailable for follow-up assessments

Accepts Healthy Volunteers

Yes

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

Label	URL
Center for Adolescent Substance Abuse Research	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism
D012309	Risk-Taking
D000066608	Underage Drinking

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008403	Mass Screening
D003419	Crisis Intervention

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D006306	Health Surveys
D011795	Surveys and Questionnaires

Browse Leaves

Not provided

Browse Branches

Not provided