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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228044
• Other study ID #: 5970
• Secondary ID: R01AA016854
• Status: Completed
• Phase: N/A
• First received: August 25, 2014
• Last updated: August 26, 2014
• Start date: September 2008
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: George Mason University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: George Mason University Human Subjects Review BoardUnited States: National Institute on Alcohol Abuse and Alcoholism
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Abuse
• Drug Abuse
• HIV
• Suicide

Intervention

Behavioral:
• Prevention program

Locations

Country	Name	City	State
United States	George Mason University	Fairfax	Virginia

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change from baseline to 6 months (prior 3 months)	No
Primary	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	change from baseline to 6 months (prior month to 6 months)	Yes
Primary	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.	change from baseline to 6 months (prior 3 months)	No
Primary	adolescent marijuana use (any use, number of days, related problems)	This was assessed with the Customary Drinking and Drug Use Measure	change from baseline to 6 months (prior 3 months)	No
Primary	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	change from baseline to 12 months (prior 3 months)	No
Primary	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	change from baseline to 12 months (prior month to 6 months)	Yes
Primary	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	change from baseline to 12 months (prior 3 months)	No
Primary	adolescent marijuana use (any use, number of days, related problems)	This was assessed with the Customary Drinking and Drug Use Record	change from baseline to 12 months (prior 3 months)	No
Secondary	frequency of parental monitoring behavior	This was assessed with the Parental Monitoring Questionnaire	change from baseline to 1 month	No
Secondary	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	change from baseline to 1 month	No
Secondary	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	change from baseline to 1 month	No
Secondary	adolescent perception of degree of interpersonal coping and stress management skills	This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version	change from baseline to 6 months	No
Secondary	adolescent degree of perceived self-efficacy for condom use	This was assessed with the Self-Efficacy for Condom Use Scale	change from baseline to 1 month	No
Secondary	adolescent degree of HIV related knowledge	This was assessed with the HIV Knowledge Scale	change from baseline to 1 month	No
Secondary	adolescent perceptions of degree of peer substance use and tolerance of use	This was assessed with Peer Substance Use and Tolerance of Use scale	change from baseline to 6 months	No
Secondary	adolescent perception of the degree of peer approval of sexual activity	This was assessed with the Peer Norms Scale for Sexual Activity scale	change from baseline to 6 months	No
Secondary	adolescent degree of perceived self-efficacy for HIV prevention	This was assessed with the Self-Efficacy for HIV Prevention Scale	change from baseline to 1 month	No
Secondary	frequency of positive and negative thoughts related to suicide	This was assessed with the Positive and Negative Suicide Ideation Inventory	change from baseline to 1 month	Yes
Secondary	degree of adolescent positive/negative attitudes and beliefs about alcohol	This was assessed with the Youth Alcohol and Drug Survey	change from baseline to 1 month	No
Secondary	degree of adolescent positive/negative attitudes and beliefs about marijuana use	This was assessed with the Youth Alcohol and Drug Survey	change from baseline to 1 month	No
Secondary	frequency of parental monitoring behavior	This was assessed with the parental monitoring questionnaire	change from baseline to 6 months	No
Secondary	frequency of parental monitoring behavior	This was assessed with the parental monitoring questionnaire	change from baseline to 12 months	No
Secondary	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	change from baseline to 6 months	No
Secondary	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	change from baseline to 12 months	No
Secondary	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	change from baseline to 6 months	No
Secondary	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	change from baseline to 12 months	No
Secondary	adolescent perception of degree of interpersonal and stress management coping skills	This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version	change from baseline to 12 months	No
Secondary	adolescent perceptions of degree of peer substance use and approval of use	This was assessed with Peer Substance Use and Tolerance of Use scale	change from baseline to 12 months	No
Secondary	adolescent perception of the degree of peer approval of sexual activity	This was assessed with the Peer Norms Scale for Sexual Activity scale	change from baseline to 12 months	No