- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02228044
Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment
August 26, 2014 updated by: George Mason University
Alcohol, Suicide, and HIV Prevention for Teens in Mental Health Treatment
This study examines whether an integrated alcohol/substance abuse, suicide, and HIV prevention protocol is associated with lower onset and frequency of alcohol and other drug use, suicidal behavior, and high risk sexual behavior among adolescents receiving community based mental health care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to compare an integrated adolescent alcohol/drug, suicide, and HIV prevention program to an assessment only control condition in a randomized clinical trial.
This prevention protocol is designed as an "add-on" intervention to standard mental health care.
We will examine the extent to which the addition of this prevention protocol is associated with lower rates of alcohol use and drug use, suicidal behavior, and HIV related risk behaviors.
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Fairfax, Virginia, United States, 22030
- George Mason University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ages 13-18
- English speaking adolescent and at least one English speaking parent
- receiving mental health treatment
- living with a parent or guardian willing to participate
Exclusion Criteria:
- Active Alcohol or Marijuana Dependence Diagnosis
- HIV infection
- Pregnant
- Current psychosis
- Cognitively unable to give assent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Assessment Only
|
|
Experimental: Prevention Program
This is a cognitive-behavioral substance abuse, suicide, and HIV prevention program delivered in a workshop format to adolescent participants and their parents/legal guardians.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adolescent alcohol use and binge drinking (any, number of days, number of related problems)
Time Frame: change from baseline to 6 months (prior 3 months)
|
This was assessed using the Customary Drinking and Drug Use Record
|
change from baseline to 6 months (prior 3 months)
|
adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior)
Time Frame: change from baseline to 6 months (prior month to 6 months)
|
This was assessed using the Suicidal ideation Questionnaire and the Self-Injurious Thoughts and Behavior Interview
|
change from baseline to 6 months (prior month to 6 months)
|
adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts)
Time Frame: change from baseline to 6 months (prior 3 months)
|
This was assessed using the Adolescent Risk Behavior Assessment.
|
change from baseline to 6 months (prior 3 months)
|
adolescent marijuana use (any use, number of days, related problems)
Time Frame: change from baseline to 6 months (prior 3 months)
|
This was assessed with the Customary Drinking and Drug Use Measure
|
change from baseline to 6 months (prior 3 months)
|
adolescent alcohol use and binge drinking (any, number of days, number of related problems)
Time Frame: change from baseline to 12 months (prior 3 months)
|
This was assessed using the Customary Drinking and Drug Use Measure
|
change from baseline to 12 months (prior 3 months)
|
adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior)
Time Frame: change from baseline to 12 months (prior month to 6 months)
|
This was assessed with the Suicidal Ideation Questionnaire and the Self-Injurious Thoughts and Behavior Questionnaire
|
change from baseline to 12 months (prior month to 6 months)
|
adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts)
Time Frame: change from baseline to 12 months (prior 3 months)
|
This was assessed with the Adolescent Risk Behavior Assessment
|
change from baseline to 12 months (prior 3 months)
|
adolescent marijuana use (any use, number of days, related problems)
Time Frame: change from baseline to 12 months (prior 3 months)
|
This was assessed with the Customary Drinking and Drug Use Record
|
change from baseline to 12 months (prior 3 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
frequency of parental monitoring behavior
Time Frame: change from baseline to 1 month
|
This was assessed with the Parental Monitoring Questionnaire
|
change from baseline to 1 month
|
quality of parent-child communication around high risk behaviors
Time Frame: change from baseline to 1 month
|
This was assessed with the Parent-Adolescent Sexual Communication Scale and items adapted for alcohol/drug use and suicidal behavior
|
change from baseline to 1 month
|
adolescent perceptions of parental degree of disapproval of high risk behavior
Time Frame: change from baseline to 1 month
|
This was assessed with Parental Norms for Sexual Activity and Supervision Scale and items adapted for alcohol/drug use
|
change from baseline to 1 month
|
adolescent perception of degree of interpersonal coping and stress management skills
Time Frame: change from baseline to 6 months
|
This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version
|
change from baseline to 6 months
|
adolescent degree of perceived self-efficacy for condom use
Time Frame: change from baseline to 1 month
|
This was assessed with the Self-Efficacy for Condom Use Scale
|
change from baseline to 1 month
|
adolescent degree of HIV related knowledge
Time Frame: change from baseline to 1 month
|
This was assessed with the HIV Knowledge Scale
|
change from baseline to 1 month
|
adolescent perceptions of degree of peer substance use and tolerance of use
Time Frame: change from baseline to 6 months
|
This was assessed with Peer Substance Use and Tolerance of Use scale
|
change from baseline to 6 months
|
adolescent perception of the degree of peer approval of sexual activity
Time Frame: change from baseline to 6 months
|
This was assessed with the Peer Norms Scale for Sexual Activity scale
|
change from baseline to 6 months
|
adolescent degree of perceived self-efficacy for HIV prevention
Time Frame: change from baseline to 1 month
|
This was assessed with the Self-Efficacy for HIV Prevention Scale
|
change from baseline to 1 month
|
frequency of positive and negative thoughts related to suicide
Time Frame: change from baseline to 1 month
|
This was assessed with the Positive and Negative Suicide Ideation Inventory
|
change from baseline to 1 month
|
degree of adolescent positive/negative attitudes and beliefs about alcohol
Time Frame: change from baseline to 1 month
|
This was assessed with the Youth Alcohol and Drug Survey
|
change from baseline to 1 month
|
degree of adolescent positive/negative attitudes and beliefs about marijuana use
Time Frame: change from baseline to 1 month
|
This was assessed with the Youth Alcohol and Drug Survey
|
change from baseline to 1 month
|
frequency of parental monitoring behavior
Time Frame: change from baseline to 6 months
|
This was assessed with the parental monitoring questionnaire
|
change from baseline to 6 months
|
frequency of parental monitoring behavior
Time Frame: change from baseline to 12 months
|
This was assessed with the parental monitoring questionnaire
|
change from baseline to 12 months
|
quality of parent-child communication around high risk behaviors
Time Frame: change from baseline to 6 months
|
This was assessed with the Parent-Adolescent Sexual Communication Scale and items adapted for alcohol/drug use and suicidal behavior
|
change from baseline to 6 months
|
quality of parent-child communication around high risk behaviors
Time Frame: change from baseline to 12 months
|
This was assessed with the Parent-Adolescent Sexual Communication Scale and items adapted for alcohol/drug use and suicidal behavior
|
change from baseline to 12 months
|
adolescent perceptions of parental degree of disapproval of high risk behavior
Time Frame: change from baseline to 6 months
|
This was assessed with Parental Norms for Sexual Activity and Supervision Scale and items adapted for alcohol/drug use
|
change from baseline to 6 months
|
adolescent perceptions of parental degree of disapproval of high risk behavior
Time Frame: change from baseline to 12 months
|
This was assessed with Parental Norms for Sexual Activity and Supervision Scale and items adapted for alcohol/drug use
|
change from baseline to 12 months
|
adolescent perception of degree of interpersonal and stress management coping skills
Time Frame: change from baseline to 12 months
|
This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version
|
change from baseline to 12 months
|
adolescent perceptions of degree of peer substance use and approval of use
Time Frame: change from baseline to 12 months
|
This was assessed with Peer Substance Use and Tolerance of Use scale
|
change from baseline to 12 months
|
adolescent perception of the degree of peer approval of sexual activity
Time Frame: change from baseline to 12 months
|
This was assessed with the Peer Norms Scale for Sexual Activity scale
|
change from baseline to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christianne Esposito-Smythers, Ph.D., George Mason University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
August 25, 2014
First Submitted That Met QC Criteria
August 26, 2014
First Posted (Estimate)
August 28, 2014
Study Record Updates
Last Update Posted (Estimate)
August 28, 2014
Last Update Submitted That Met QC Criteria
August 26, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5970
- R01AA016854 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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