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Clinical Trials

MainTitle

Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment

This study has been completed
Sponsor
George Mason University

Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information provided by (Responsible Party)
George Mason University
ClinicalTrials.gov Identifier
NCT02228044

First received: August 25, 2014
Last updated: August 26, 2014
Last Verified: August 2014
History of Changes
Purpose

Purpose

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.

Condition Intervention
Suicide
Alcohol Abuse
Drug Abuse
HIV

Behavioral : Prevention program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Alcohol, Suicide, and HIV Prevention for Teens in Mental Health Treatment

Further study details as provided by George Mason University:

Primary Outcome Measures

  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
Secondary Outcome Measures:
  • frequency of parental monitoring behavior [ Time Frame: change from baseline to 1 month ]
    This was assessed with the Parental Monitoring Questionnaire
  • 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
  • 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
  • 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
  • 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
  • adolescent degree of HIV related knowledge [ Time Frame: change from baseline to 1 month ]
    This was assessed with the HIV Knowledge Scale
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • frequency of parental monitoring behavior [ Time Frame: change from baseline to 6 months ]
    This was assessed with the parental monitoring questionnaire
  • frequency of parental monitoring behavior [ Time Frame: change from baseline to 12 months ]
    This was assessed with the parental monitoring questionnaire
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Enrollment: 81
Study Start Date: September 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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
No Intervention: Assessment Only

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.

Eligibility

Eligibility

Ages Eligible for Study: 13 Years to 18 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02228044

Locations

United States, Virginia
George Mason University
Fairfax, Virginia, United States, 22030

Sponsors and Collaborators

George Mason University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator: Christianne Esposito-Smythers, Ph.D. George Mason University
More Information

More Information


Responsible Party: George Mason University  
ClinicalTrials.gov Identifier: NCT02228044   History of Changes  
Other Study ID Numbers: 5970  
  R01AA016854  
Study First Received: August 25, 2014  
Last Updated: August 26, 2014  

Keywords provided by George Mason University:

suicide
alcohol
marijuana
HIV
prevention
adolescent

Additional relevant MeSH terms:
Suicide
Alcoholism
Substance-Related Disorders
Ethanol

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.