Therapeutic Schools: Affect Management and HIV Prevention

NCT ID: NCT00500487

Last Updated: 2015-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

Affect Management

Intervention Type BEHAVIORAL

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

2

Group Type ACTIVE_COMPARATOR

HIV Prevention Skills

Intervention Type BEHAVIORAL

12-session group intervention including sexual health skills training.

3

Group Type ACTIVE_COMPARATOR

General Health Promotion

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Affect Management

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

Intervention Type BEHAVIORAL

HIV Prevention Skills

12-session group intervention including sexual health skills training.

Intervention Type BEHAVIORAL

General Health Promotion

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Chicago

OTHER

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Larry K Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28545758 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH066641

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01MH066641

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.