Facilitating Adolescent Self-Change for Alcohol Problems | NCT01690026

Studies
Facilitating Adolescent Self-Change for Alcohol Problems

NCT01690026

Sponsor

University of California, San Diego

Status

Completed

Last Update Posted

Nov 6, 2017Actual

Enrollment

1,209Actual

Phase

Not Applicable

Conditions

Underage Drinking

Interventions

Motivation interviewing based brief intervention
Standard Intervention

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Mar 2017Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Sep 12, 2012

First Submission Date that Met QC Criteria

Sep 17, 2012

First Posted Date

Sep 21, 2012Estimated

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

Nov 1, 2017

Last Update Posted Date

Nov 6, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sandra Brown, Vice-Chancellor of Research, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

This present multi-site investigation compares a voluntary brief intervention for adolescent alcohol problems to an educational comparison condition. Measures are taken at intake and at 4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal change efforts and arrest progression of alcohol problems. This study tests cognitive mechanisms of change and treatment characteristics and processes associated with youth self-regulation to reduce or stop hazardous drinking.

Detailed Description

Not provided

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

1,209Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brief intervention	Other	Motivational intervention based brief intervention	Behavioral: Motivation interviewing based brief intervention
Standard intervention	Other	Standard intervention condition	Behavioral: Standard Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motivation interviewing based brief intervention	Behavioral		Brief intervention
Standard Intervention

Measure	Description	Time Frame
Alcohol use and problems		one year

Measure	Description	Time Frame
Cognitive mediators		one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All 9th-12th graders at six schools from 3 sites across the country are eligible to participate, regardless of alcohol experience

Exclusion Criteria:

exclusion prior to 9th grade and after 12th grade

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Drug Free Youth in Town		Miami	Florida	33157-3459	United States
University of Minnesota

Condition Browse Module

MeSH Terms

ID	Term
D000066608	Underage Drinking

Ancestor Terms

ID	Term
D000294	Adolescent Behavior
D001519	Behavior
D000428	Alcohol Drinking
D004327	Drinking Behavior

Browse Leaves

Not provided

Browse Branches

Not provided