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

Primary Purpose

Suicide, Alcohol Abuse, Drug Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevention program
Sponsored by
George Mason University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring suicide, alcohol, marijuana, HIV, prevention, adolescent

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • George Mason University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prevention Program

Assessment Only

Arm Description

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.

Outcomes

Primary Outcome Measures

adolescent alcohol use and binge drinking (any, number of days, number of related problems)
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)
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)
This was assessed using the Adolescent Risk Behavior Assessment.
adolescent marijuana use (any use, number of days, related problems)
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)
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)
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)
This was assessed with the Adolescent Risk Behavior Assessment
adolescent marijuana use (any use, number of days, related problems)
This was assessed with the Customary Drinking and Drug Use Record

Secondary Outcome Measures

frequency of parental monitoring behavior
This was assessed with the Parental Monitoring Questionnaire
quality of parent-child communication around high risk behaviors
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
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
This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version
adolescent degree of perceived self-efficacy for condom use
This was assessed with the Self-Efficacy for Condom Use Scale
adolescent degree of HIV related knowledge
This was assessed with the HIV Knowledge Scale
adolescent perceptions of degree of peer substance use and tolerance of use
This was assessed with Peer Substance Use and Tolerance of Use scale
adolescent perception of the degree of peer approval of sexual activity
This was assessed with the Peer Norms Scale for Sexual Activity scale
adolescent degree of perceived self-efficacy for HIV prevention
This was assessed with the Self-Efficacy for HIV Prevention Scale
frequency of positive and negative thoughts related to suicide
This was assessed with the Positive and Negative Suicide Ideation Inventory
degree of adolescent positive/negative attitudes and beliefs about alcohol
This was assessed with the Youth Alcohol and Drug Survey
degree of adolescent positive/negative attitudes and beliefs about marijuana use
This was assessed with the Youth Alcohol and Drug Survey
frequency of parental monitoring behavior
This was assessed with the parental monitoring questionnaire
frequency of parental monitoring behavior
This was assessed with the parental monitoring questionnaire
quality of parent-child communication around high risk behaviors
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
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
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
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
This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version
adolescent perceptions of degree of peer substance use and approval of use
This was assessed with Peer Substance Use and Tolerance of Use scale
adolescent perception of the degree of peer approval of sexual activity
This was assessed with the Peer Norms Scale for Sexual Activity scale

Full Information

First Posted
August 25, 2014
Last Updated
August 26, 2014
Sponsor
George Mason University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02228044
Brief Title
Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment
Official Title
Alcohol, Suicide, and HIV Prevention for Teens in Mental Health Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
George Mason University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Alcohol Abuse, Drug Abuse, HIV
Keywords
suicide, alcohol, marijuana, HIV, prevention, adolescent

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevention Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Assessment Only
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Prevention program
Primary Outcome Measure Information:
Title
adolescent alcohol use and binge drinking (any, number of days, number of related problems)
Description
This was assessed using the Customary Drinking and Drug Use Record
Time Frame
change from baseline to 6 months (prior 3 months)
Title
adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior)
Description
This was assessed using the Suicidal ideation Questionnaire and the Self-Injurious Thoughts and Behavior Interview
Time Frame
change from baseline to 6 months (prior month to 6 months)
Title
adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts)
Description
This was assessed using the Adolescent Risk Behavior Assessment.
Time Frame
change from baseline to 6 months (prior 3 months)
Title
adolescent marijuana use (any use, number of days, related problems)
Description
This was assessed with the Customary Drinking and Drug Use Measure
Time Frame
change from baseline to 6 months (prior 3 months)
Title
adolescent alcohol use and binge drinking (any, number of days, number of related problems)
Description
This was assessed using the Customary Drinking and Drug Use Measure
Time Frame
change from baseline to 12 months (prior 3 months)
Title
adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior)
Description
This was assessed with the Suicidal Ideation Questionnaire and the Self-Injurious Thoughts and Behavior Questionnaire
Time Frame
change from baseline to 12 months (prior month to 6 months)
Title
adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts)
Description
This was assessed with the Adolescent Risk Behavior Assessment
Time Frame
change from baseline to 12 months (prior 3 months)
Title
adolescent marijuana use (any use, number of days, related problems)
Description
This was assessed with the Customary Drinking and Drug Use Record
Time Frame
change from baseline to 12 months (prior 3 months)
Secondary Outcome Measure Information:
Title
frequency of parental monitoring behavior
Description
This was assessed with the Parental Monitoring Questionnaire
Time Frame
change from baseline to 1 month
Title
quality of parent-child communication around high risk behaviors
Description
This was assessed with the Parent-Adolescent Sexual Communication Scale and items adapted for alcohol/drug use and suicidal behavior
Time Frame
change from baseline to 1 month
Title
adolescent perceptions of parental degree of disapproval of high risk behavior
Description
This was assessed with Parental Norms for Sexual Activity and Supervision Scale and items adapted for alcohol/drug use
Time Frame
change from baseline to 1 month
Title
adolescent perception of degree of interpersonal coping and stress management skills
Description
This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version
Time Frame
change from baseline to 6 months
Title
adolescent degree of perceived self-efficacy for condom use
Description
This was assessed with the Self-Efficacy for Condom Use Scale
Time Frame
change from baseline to 1 month
Title
adolescent degree of HIV related knowledge
Description
This was assessed with the HIV Knowledge Scale
Time Frame
change from baseline to 1 month
Title
adolescent perceptions of degree of peer substance use and tolerance of use
Description
This was assessed with Peer Substance Use and Tolerance of Use scale
Time Frame
change from baseline to 6 months
Title
adolescent perception of the degree of peer approval of sexual activity
Description
This was assessed with the Peer Norms Scale for Sexual Activity scale
Time Frame
change from baseline to 6 months
Title
adolescent degree of perceived self-efficacy for HIV prevention
Description
This was assessed with the Self-Efficacy for HIV Prevention Scale
Time Frame
change from baseline to 1 month
Title
frequency of positive and negative thoughts related to suicide
Description
This was assessed with the Positive and Negative Suicide Ideation Inventory
Time Frame
change from baseline to 1 month
Title
degree of adolescent positive/negative attitudes and beliefs about alcohol
Description
This was assessed with the Youth Alcohol and Drug Survey
Time Frame
change from baseline to 1 month
Title
degree of adolescent positive/negative attitudes and beliefs about marijuana use
Description
This was assessed with the Youth Alcohol and Drug Survey
Time Frame
change from baseline to 1 month
Title
frequency of parental monitoring behavior
Description
This was assessed with the parental monitoring questionnaire
Time Frame
change from baseline to 6 months
Title
frequency of parental monitoring behavior
Description
This was assessed with the parental monitoring questionnaire
Time Frame
change from baseline to 12 months
Title
quality of parent-child communication around high risk behaviors
Description
This was assessed with the Parent-Adolescent Sexual Communication Scale and items adapted for alcohol/drug use and suicidal behavior
Time Frame
change from baseline to 6 months
Title
quality of parent-child communication around high risk behaviors
Description
This was assessed with the Parent-Adolescent Sexual Communication Scale and items adapted for alcohol/drug use and suicidal behavior
Time Frame
change from baseline to 12 months
Title
adolescent perceptions of parental degree of disapproval of high risk behavior
Description
This was assessed with Parental Norms for Sexual Activity and Supervision Scale and items adapted for alcohol/drug use
Time Frame
change from baseline to 6 months
Title
adolescent perceptions of parental degree of disapproval of high risk behavior
Description
This was assessed with Parental Norms for Sexual Activity and Supervision Scale and items adapted for alcohol/drug use
Time Frame
change from baseline to 12 months
Title
adolescent perception of degree of interpersonal and stress management coping skills
Description
This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version
Time Frame
change from baseline to 12 months
Title
adolescent perceptions of degree of peer substance use and approval of use
Description
This was assessed with Peer Substance Use and Tolerance of Use scale
Time Frame
change from baseline to 12 months
Title
adolescent perception of the degree of peer approval of sexual activity
Description
This was assessed with the Peer Norms Scale for Sexual Activity scale
Time Frame
change from baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christianne Esposito-Smythers, Ph.D.
Organizational Affiliation
George Mason University
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Mason University
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27883927
Citation
Esposito-Smythers C, Hadley W, Curby TW, Brown LK. Randomized pilot trial of a cognitive-behavioral alcohol, self-harm, and HIV prevention program for teens in mental health treatment. Behav Res Ther. 2017 Feb;89:49-56. doi: 10.1016/j.brat.2016.11.005. Epub 2016 Nov 12.
Results Reference
derived

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

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