Affect Management for Early Adolescents

HIV Infections Clinical Trial

Official title:

Affect Management Intervention for Early Adolescents With Mental Health Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197404
• Other study ID #: R01NR011906
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2010
• Last updated: March 2, 2016
• Start date: August 2009
• Est. completion date: November 2014

Study information

• Verified date: March 2016
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 14 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Affect Management
12-session group intervention including affect management training as well as sexual health skills training.
• General Health Promotion
12-session group intervention including health information on a variety of developmentally relevant health topics.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adolescent-reported sexual activity		30 Months	No
Secondary	Adolescent-reported condom use		30 Months	No