Adolescent Safer Sex Social Network Intervention

NCT00107562 | Completed

• 1 other identifier: ATN 032
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Social networks are thought to hold the potential for shaping behavior on the grounds that social and situational factors more strongly influence behavior than do personality variables. This is a behavioral intervention study that will test a 6-session, small-group, peer-network intervention among adolescent males and females and their friends. The intervention primarily focuses on reducing risky sexual behavior and increasing condom use among adolescent males and females, aged 16-19. The concurrent use of alcohol and marijuana during sex is also a focus as these two substances are widely used among adolescents and fuel risky sexual behavior.

Conditions

Sexual Behavior; Alcohol Drinking; Marijuana Smoking

Keywords

risk behavior; social networks; behavior

Outcome Measures

Primary Outcomes (1)

• Test the feasibility, acceptability and preliminary effectiveness intervention

  The objective of this Phase II study is to test the feasibility, acceptability and preliminary effectiveness of a 6-session, small-group, peer-network intervention among adolescent males and females and their friendship networks. The ultimate goal is to test the intervention in a randomized, attention-controlled, Phase III trial.

  6 Months

Study Arms (1)

Intervention

EXPERIMENTAL

The cohort will be comprised of up to 4 index participants and from 1-4 of their network members for a possible range of 8-16 subjects in each cohort (average of 12 per cohort). The vast majority of the intervention will be delivered to both females and males together, but it would be beneficial, and appropriate for this adolescent population, to deliver certain exercises with the two genders separated.

Behavioral: Adolescent Safer Sex Social Network Intervention

Interventions

Adolescent Safer Sex Social Network Intervention BEHAVIORAL

Intervention

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Self-identifies as all or part "Latino"
• Age is between 16 years and 0 days and 19 years and 364 days at the time of study enrollment
• In the past 3 months, reports engaging in any type of heterosexual sex (vaginal, oral or anal) with an opposite-sex partner
• In the past 3 months, reports any of the following:
• alcohol use at least once;
• marijuana use at least once;
• having sex while drunk or high.
• Must understand spoken and written English sufficiently to provide consent/assent and be interviewed and attend intervention workshops delivered in English
• Must live in the Boston or Tampa area, and plan to be available for study appointments (vacation allowed if not interfering with the planned intervention or follow up dates)
• Age is between 16 years and 0 days to 19 years and 364 days at the time of study enrollment
• In the past 3 months, reports engaging in any type of heterosexual sex (vaginal, oral or anal) with an opposite-sex partner
• Must understand spoken and written English sufficiently to provide consent/assent and be interviewed and attend intervention workshops delivered in English
• Must live in the Boston or Tampa area, and plan to be available for study appointments (vacation allowed if not interfering with the planned intervention or follow up dates)
• Must be reported by an index as a friend who:
• has been known for at least 6 months;

You may not qualify if:

• Reports only same sex behavior
• Reports being HIV positive, as measured by self-report
• Reports having engaged in behaviors in the past year that are defined as "severe" physical abuse of others on the Conflict Tactics Scale
• In the past year, reports having made someone engage in sexual things that he or she did not want to do either by holding the partner down, hurting or by threatening them in some way
• Unable to nominate at least one eligible friend to participate in the intervention
• Reports having ever used heroin, crack, cocaine, or metamphetamines
• Reports alcohol dependence as measured by affirmative answers to 3 or more out of 7 questions on the Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) based criteria of substance dependence
• Reports marijuana dependence as measured by affirmative answers to 3 or more out of 7 questions on the DSM-IV based criteria of substance dependence
• Reports being an active member of a gang
• Reports or is known by staff to be currently participating in any other bio-medical or Adolescent Trial Network (ATN)-related intervention study or trial
• If female, reports being currently pregnant
• Unwilling to be screened for sexually transmitted infections (STIs)
• Prior participation in this study intervention as either an index or a network member as determined by review of study logs
• Is currently romantically involved with the index who named him/her
• Has ever had vaginal, oral or anal sex with the index

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

University of South Florida College of Medicine

Tampa, Florida, 33606, United States

Location

Children's Hospital of Boston

Boston, Massachusetts, 02115, United States

Location

Related Links

• description of the Adolescent Trials Network and contact information

MeSH Terms

Conditions

Sexual Behavior; Alcohol Drinking; Marijuana Smoking; Risk-Taking; Behavior

Condition Hierarchy (Ancestors)

Drinking Behavior; Marijuana Use; Smoking, Non-Tobacco Products; Smoking

Study Officials

• Mary Latka, PhD

  New York Academy of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2005
• First Posted: April 6, 2005
• Study Start: February 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: February 28, 2017

Record last verified: 2016-02

Locations

US (2)