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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Prevention program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
George Mason University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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