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| Sponsored by: |
Rhode Island Hospital |
|---|---|
| Information provided by: | Rhode Island Hospital |
| ClinicalTrials.gov Identifier: | NCT00741975 |
Purpose
Adolescents are at risk for HIV because of sexual and drug use behavior initiated during early adolescence, and those with mental health problems appear to be particularly susceptible. Problems with managing emotions may make it difficult for early adolescents to make good decisions about sexual and substance use behaviors. This project will develop and evaluate interventions for early adolescents with mental health issues. An intervention focused on teaching affect management skills will be compared to an intervention addressing a variety of health topics to determine which intervention best reduces risk behavior among this at-risk population.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Behavioral: Affect Management Behavioral: General Health Promotion |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Affect Management Intervention for Early Adolescents With Mental Health Problems |
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Affect Management
|
Behavioral: Affect Management
12-session group intervention including affect management training as well as sexual health skills training
|
|
2: Active Comparator
General Health Promotion
|
Behavioral: General Health Promotion
12-session group intervention including health information on a variety of developmentally relevant health topics
|
Eligibility| Ages Eligible for Study: | 12 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christopher D Houck, PhD | 401-444-8539 | chouck@lifespan.org |
| Contact: Wendy Hadley, PhD | 401-44-8539 | whadley@lifespan.org |
| United States, Rhode Island | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Christopher D Houck, PhD 401-444-8539 chouck@lifespan.org | |
| Principal Investigator: | Christopher D Houck, Phd | Rhode Island Hospital |
More Information
| Responsible Party: | Rhode Island Hospital ( Christopher D. Houck/Principal Investigator ) |
| Study ID Numbers: | R34 MH 78750, R34 MH 78750 |
| Study First Received: | August 25, 2008 |
| Last Updated: | August 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00741975 |
| Health Authority: | United States: Institutional Review Board |
|
HIV prevention |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |
