Therapeutic Schools: Affect Management and HIV Prevention | NCT00500487

Studies
Therapeutic Schools: Affect Management and HIV Prevention

NCT00500487

Sponsor

Rhode Island Hospital

Status

Completed

Last Update Posted

Jan 12, 2015Estimated

Enrollment

420Estimated

Phase

Phase 1

Conditions

HIV Infections

Interventions

Affect Management
HIV Prevention Skills
General Health Promotion

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

ID	Type	Description	Link
R01MH066641	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2009

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

Apr 2003

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jul 11, 2007

First Submission Date that Met QC Criteria

Jul 11, 2007

First Posted Date

Jul 12, 2007Estimated

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

Jan 9, 2015

Last Update Posted Date

Jan 12, 2015Estimated

Name	Class
University of Chicago	OTHER

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

Adolescents are at risk for HIV because of sexual and drug behavior intiated during this developmental period. Those with psychological distress are less likely than their peers to benefit from frequently used skills-based interventions. It appears that emotional lability during sexual situations disrupts skills learned. This project will implement and evaluate interventions for adolescents with psychiatric disorders who are in therapeutic school settings. Affect management and skills-based interventions will be compared to a didactic standard of care condition to determine which intervention best reduces risk behavior among adolescents with psychiatric disorders in therapeutic school settings.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

420Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Behavioral: Affect Management
2	Active Comparator	Behavioral: HIV Prevention Skills
3	Active Comparator	Behavioral: General Health Promotion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Affect Management	Behavioral	12-session group intervention including affect management training as well as sexual health skills training.	1

Measure	Description	Time Frame
Adolescent-reported condom use		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adolescent attending therapeutic school

Exclusion Criteria:

Adolescent is HIV positive
Adolescent is developmentally delayed
Adolescent is pregnant
Adolescent has a history of sexual crime

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Larry K Brown, MD	Rhode Island Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rhode Island Hospital		Providence	Rhode Island	02903	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28545758	Derived	Brown LK, Whiteley L, Houck CD, Craker LK, Lowery A, Beausoleil N, Donenberg G. The Role of Affect Management for HIV Risk Reduction for Youth in Alternative Schools. J Am Acad Child Adolesc Psychiatry. 2017 Jun;56(6):524-531. doi: 10.1016/j.jaac.2017.03.010. Epub 2017 Mar 31.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral