Overview

This trial is active, not recruiting.

Conditions risk reduction behavior, sexual behavior, health behavior, drinking behavior, adolescent behavior
Treatments sexual risk reduction + alcohol risk reduction, information-only sexual risk reduction
Sponsor University of New Mexico
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date October 2007
End date September 2012
Trial size 250 participants
Trial identifier NCT01169922, NIAAA RO1 AA017390-01

Summary

This research is examining how genetic and brain factors play a role in adolescents' health risk behavior as well as studying behaviors that young people engage in that may place them at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational program works best to reduce these risky behaviors.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Intervention contains information geared toward sexual risk reduction as well as alcohol risk reduction.
sexual risk reduction + alcohol risk reduction SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION (SRRI+ETOH)
2 hour 50 minute long intervention; includes presentation of STD/HIV facts, activities/games regarding safe sex, condom demonstration, video about sexual decision making, video about alcohol/sexual decision making, alcohol-related risk-reduction motivational interview, group discussion
(Active Comparator)
Intervention contains information geared toward sexual risk reduction only.
information-only sexual risk reduction INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)
1 hour 30 minute long intervention; includes presentation of STD/HIV facts, video about sexually transmitted diseases, review of STD/HIV facts

Primary Outcomes

Measure
Time-Line Follow-Back (TLFB)
time frame: 3-months post-intervention
Time-Line Follow-Back (TLFB)
time frame: 6-months post-intervention
Time-Line Follow-Back (TLFB)
time frame: 9-months post-intervention
Time-Line Follow-Back (TLFB)
time frame: 12-months post-intervention

Secondary Outcomes

Measure
Computer questionnaire
time frame: 3 months post-intervention
Computer questionnaire
time frame: 6 months post-intervention
Computer questionnaire
time frame: 9 months post-intervention
Computer questionnaire
time frame: 12 months post-intervention

Eligibility Criteria

Male or female participants from 14 years up to 18 years old.

Inclusion Criteria: - Adolescents age 14-18 - Involved in Juvenile Justice System OR enrolled in a private school Exclusion Criteria: - Currently taking anti-psychotics - Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)

Additional Information

Description A baseline assessment is conducted, including a computer questionnaire assessing personality characteristics, attitudes toward and experiences with sex, alcohol, drugs, and cigarettes, among other things. The participant also meets with a therapist to conduct a brief motivational interview at this time. A "Time-Line Follow-Back" is conducted; this notes incidences of sexual intercourse, alcohol use, marijuana use, and cigarette use in a 30-day period. An fMRI is conducted, and a saliva sample is gathered. During the second session of the study, participants are randomly assigned to either a sex and alcohol risk reduction intervention, or a sex risk reduction intervention. After the intervention, participants are contacted at 3 month intervals (3 months later, 6 months later, 9 months later, and 12 months later) to meet. At these "follow-up" meetings, another Time-Line Follow-Back is conducted, along with another computer questionnaire (again assessing attitudes toward and experiences with sex, alcohol, drugs, and cigarettes).
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by University of New Mexico.