Back to resultsAffect Management for Early Adolescents
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Affect Management
General Health Promotion
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Prevention
Eligibility 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.
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
General Health Promotion
Affect Management
Arm Description
Outcomes
Primary Outcome Measures
Adolescent-reported sexual activity
Secondary Outcome Measures
Adolescent-reported condom use
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01197404
Brief Title
Affect Management for Early Adolescents
Official Title
Affect Management Intervention for Early Adolescents With Mental Health Problems
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General Health Promotion
Arm Type
Active Comparator
Arm Title
Affect Management
Arm Type
Experimental
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)
General Health Promotion
Intervention Description
12-session group intervention including health information on a variety of developmentally relevant health topics.
Primary Outcome Measure Information:
Title
Adolescent-reported sexual activity
Time Frame
30 Months
Secondary Outcome Measure Information:
Title
Adolescent-reported condom use
Time Frame
30 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Houck, PhD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26297499
Citation
Houck CD, Hadley W, Barker D, Brown LK, Hancock E, Almy B. An Emotion Regulation Intervention to Reduce Risk Behaviors Among at-Risk Early Adolescents. Prev Sci. 2016 Jan;17(1):71-82. doi: 10.1007/s11121-015-0597-0.
Results Reference
result
PubMed Identifier
29748192
Citation
Houck CD, Barker DH, Hadley W, Menefee M, Brown LK. Sexual Risk Outcomes of an Emotion Regulation Intervention for At-Risk Early Adolescents. Pediatrics. 2018 Jun;141(6):e20172525. doi: 10.1542/peds.2017-2525. Epub 2018 May 10.
Results Reference
derived
PubMed Identifier
24394678
Citation
Houck CD, Barker D, Rizzo C, Hancock E, Norton A, Brown LK. Sexting and sexual behavior in at-risk adolescents. Pediatrics. 2014 Feb;133(2):e276-82. doi: 10.1542/peds.2013-1157. Epub 2014 Jan 6.
Results Reference
derived
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Affect Management for Early Adolescents
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