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Affect Management for Early Adolescents
This study has been completed.
Sponsor:
Rhode Island Hospital
Information provided by (Responsible Party):
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01197404
First received: September 7, 2010
Last updated: March 2, 2016
Last verified: March 2016
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Affect Management Intervention for Early Adolescents With Mental Health Problems |
Resource links provided by NLM:
Further study details as provided by Rhode Island Hospital:
Primary Outcome Measures:
- Adolescent-reported sexual activity [ Time Frame: 30 Months ]
Secondary Outcome Measures:
- Adolescent-reported condom use [ Time Frame: 30 Months ]
| Enrollment: | 420 |
| Study Start Date: | August 2009 |
| Study Completion Date: | November 2014 |
| Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: General Health Promotion |
Behavioral: General Health Promotion
12-session group intervention including health information on a variety of developmentally relevant health topics.
|
| Experimental: Affect Management |
Behavioral: Affect Management
12-session group intervention including affect management training as well as sexual health skills training.
|
Eligibility| Ages Eligible for Study: | 12 Years to 14 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Seventh graders identified by counselors at participating public school.
Exclusion Criteria:
- Adolescent is HIV positive.
- Adolescent is developmentally delayed.
- Adolescent is pregnant.
- Adolescent has a history of sexual crime.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197404
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197404
Locations
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States | |
Sponsors and Collaborators
Rhode Island Hospital
Investigators
| Principal Investigator: | Christopher D Houck, PhD | Rhode Island Hospital |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rhode Island Hospital |
| ClinicalTrials.gov Identifier: | NCT01197404 History of Changes |
| Other Study ID Numbers: |
R01NR011906 ( U.S. NIH Grant/Contract ) |
| Study First Received: | September 7, 2010 |
| Last Updated: | March 2, 2016 |
Keywords provided by Rhode Island Hospital:
|
HIV Prevention |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on July 21, 2017