NCT01169922

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

Same day

First QC Date

July 23, 2010

Last Update Submit

January 8, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Time-Line Follow-Back (TLFB)

    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.

    3-months post-intervention

  • Time-Line Follow-Back (TLFB)

    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.

    6-months post-intervention

  • Time-Line Follow-Back (TLFB)

    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.

    9-months post-intervention

  • Time-Line Follow-Back (TLFB)

    A Time-Line Follow-Back is a review of a recent 30-day period of the participant's life, wherein they note which days they engaged in any of the following activities: sexual intercourse, alcohol use, marijuana use, cigarette use. Further details are also provided, such as whether a condom was used, how many alcoholic drinks were consumed, etc.

    12-months post-intervention

Secondary Outcomes (4)

  • Computer questionnaire

    3 months post-intervention

  • Computer questionnaire

    6 months post-intervention

  • Computer questionnaire

    9 months post-intervention

  • Computer questionnaire

    12 months post-intervention

Study Arms (2)

SEXUAL PLUS ALCOHOL RISK REDUCTION

EXPERIMENTAL

Intervention contains information geared toward sexual risk reduction as well as alcohol risk reduction.

Behavioral: SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION

INFORMATION-ONLY SEXUAL RISK REDUCTION

ACTIVE COMPARATOR

Intervention contains information geared toward sexual risk reduction only.

Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION

Interventions

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

Also known as: SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION (SRRI+ETOH)
SEXUAL PLUS ALCOHOL RISK REDUCTION

1 hour 30 minute long intervention; includes presentation of STD/HIV facts, video about sexually transmitted diseases, review of STD/HIV facts

Also known as: INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)
INFORMATION-ONLY SEXUAL RISK REDUCTION

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents age 14-18
  • Involved in Juvenile Justice System OR enrolled in a private school

You may not qualify if:

  • Currently taking anti-psychotics
  • Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Diversion Meetings (Youth Services Center)

Albuquerque, New Mexico, 87107, United States

Location

Youth Reporting Center (Youth Services Center)

Albuquerque, New Mexico, 87107, United States

Location

Albuquerque Academy

Albuquerque, New Mexico, 87109, United States

Location

Sandia Preparatory School

Albuquerque, New Mexico, 87113, United States

Location

MeSH Terms

Conditions

Risk Reduction BehaviorSexual BehaviorHealth BehaviorDrinking BehaviorAdolescent Behavior

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Angela D Bryan, PhD

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 26, 2010

Study Start

October 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations