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Therapeutic Schools: Affect Management and HIV Prevention

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Affect Management

HIV Prevention Skills

General Health Promotion

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV prevention, HIV seronegativity

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Adolescent-reported condom use

Secondary Outcome Measures

Full Information

NCT ID

NCT00500487

First Posted

July 11, 2007

Last Updated

January 9, 2015

Sponsor

Rhode Island Hospital

Collaborators

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT00500487

Brief Title

Therapeutic Schools: Affect Management and HIV Prevention

Official Title

Therapeutic Schools: Affect Management and HIV Prevention

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rhode Island Hospital

Collaborators

University of Chicago

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV prevention, HIV seronegativity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Affect Management

Intervention Description

12-session group intervention including affect management training as well as sexual health skills training.

Intervention Type

Behavioral

Intervention Name(s)

HIV Prevention Skills

Intervention Description

12-session group intervention including sexual health skills training.

Intervention Type

Behavioral

Intervention Name(s)

General Health Promotion

Intervention Description

12-session group intervention including health information on a variety of health topics.

Primary Outcome Measure Information:

Title

Adolescent-reported condom use

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Larry K Brown, MD

Organizational Affiliation

Rhode Island Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28545758

Citation

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.

Results Reference

derived

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Therapeutic Schools: Affect Management and HIV Prevention

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