Clinical trial NCT02228044: 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
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Alcohol Abuse
Drug Abuse
HIV
Keywords: suicide
alcohol
marijuana
HIV
prevention
adolescent
Lead sponsor: George Mason University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-08-28
Enrollment: 81
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: adolescent alcohol use and binge drinking (any, number of days, number of related problems)
timeFrame: change from baseline to 6 months (prior 3 months)
measure: adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior)
timeFrame: change from baseline to 6 months (prior month to 6 months)
measure: adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts)
timeFrame: change from baseline to 6 months (prior 3 months)
measure: adolescent marijuana use (any use, number of days, related problems)
timeFrame: change from baseline to 6 months (prior 3 months)
measure: adolescent alcohol use and binge drinking (any, number of days, number of related problems)
timeFrame: change from baseline to 12 months (prior 3 months)
measure: adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior)
timeFrame: change from baseline to 12 months (prior month to 6 months)
measure: adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts)
timeFrame: change from baseline to 12 months (prior 3 months)
measure: adolescent marijuana use (any use, number of days, related problems)
timeFrame: change from baseline to 12 months (prior 3 months)
Secondary outcomes:
measure: frequency of parental monitoring behavior
timeFrame: change from baseline to 1 month
measure: quality of parent-child communication around high risk behaviors
timeFrame: change from baseline to 1 month
measure: adolescent perceptions of parental degree of disapproval of high risk behavior
timeFrame: change from baseline to 1 month
measure: adolescent perception of degree of interpersonal coping and stress management skills
timeFrame: change from baseline to 6 months
measure: adolescent degree of perceived self-efficacy for condom use
timeFrame: change from baseline to 1 month
measure: adolescent degree of HIV related knowledge
timeFrame: change from baseline to 1 month
measure: adolescent perceptions of degree of peer substance use and tolerance of use
timeFrame: change from baseline to 6 months
measure: adolescent perception of the degree of peer approval of sexual activity
timeFrame: change from baseline to 6 months
measure: adolescent degree of perceived self-efficacy for HIV prevention
timeFrame: change from baseline to 1 month
measure: frequency of positive and negative thoughts related to suicide
timeFrame: change from baseline to 1 month
measure: degree of adolescent positive/negative attitudes and beliefs about alcohol
timeFrame: change from baseline to 1 month
measure: degree of adolescent positive/negative attitudes and beliefs about marijuana use
timeFrame: change from baseline to 1 month
measure: frequency of parental monitoring behavior
timeFrame: change from baseline to 6 months
measure: frequency of parental monitoring behavior
timeFrame: change from baseline to 12 months
measure: quality of parent-child communication around high risk behaviors
timeFrame: change from baseline to 6 months
measure: quality of parent-child communication around high risk behaviors
timeFrame: change from baseline to 12 months
measure: adolescent perceptions of parental degree of disapproval of high risk behavior
timeFrame: change from baseline to 6 months
measure: adolescent perceptions of parental degree of disapproval of high risk behavior
timeFrame: change from baseline to 12 months
measure: adolescent perception of degree of interpersonal and stress management coping skills
timeFrame: change from baseline to 12 months
measure: adolescent perceptions of degree of peer substance use and approval of use
timeFrame: change from baseline to 12 months
measure: adolescent perception of the degree of peer approval of sexual activity
timeFrame: change from baseline to 12 months
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: George Mason University
state: Virginia
Study officials:
affiliation: George Mason University
name: Christianne Esposito-Smythers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.