NCT02228044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

5.5 years

First QC Date

August 25, 2014

Last Update Submit

August 26, 2014

Conditions

Keywords

suicidealcoholmarijuanaHIVpreventionadolescent

Outcome Measures

Primary Outcomes (8)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Secondary Outcomes (21)

  • frequency of parental monitoring behavior

    change from baseline to 1 month

  • quality of parent-child communication around high risk behaviors

    change from baseline to 1 month

  • adolescent perceptions of parental degree of disapproval of high risk behavior

    change from baseline to 1 month

  • adolescent perception of degree of interpersonal coping and stress management skills

    change from baseline to 6 months

  • adolescent degree of perceived self-efficacy for condom use

    change from baseline to 1 month

  • +16 more secondary outcomes

Study Arms (2)

Prevention Program

EXPERIMENTAL

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

Assessment Only

NO INTERVENTION

Interventions

Prevention Program

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Active Alcohol or Marijuana Dependence Diagnosis
  • HIV infection
  • Pregnant
  • Current psychosis
  • Cognitively unable to give assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Mason University

Fairfax, Virginia, 22030, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SuicideAlcoholismSubstance-Related DisordersMarijuana Abuse

Interventions

National Program of Cancer Registries

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorAlcohol-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Centers for Disease Control and Prevention, U.S.United States Public Health ServiceUnited States Dept. of Health and Human ServicesUnited States Government AgenciesFederal GovernmentGovernmentOrganizationsHealth Care Economics and Organizations

Study Officials

  • Christianne Esposito-Smythers, Ph.D.

    George Mason University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

August 28, 2014

Study Start

September 1, 2008

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations