SuicideNCT02228044
Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment
A study testing Prevention program in people with Suicide and Alcohol Abuse, run by George Mason University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Suicide, Alcohol Abuse, Drug Abuse
- What is being tested?
- Prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Active Alcohol or Marijuana Dependence Diagnosis
- HIV infection
- Pregnant
- Current psychosis
- Cognitively unable to give assent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alcohol, Suicide, and HIV Prevention for Teens in Mental Health Treatment
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.
Read the 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.
- Conditions
- Suicide, Alcohol Abuse, Drug Abuse, HIV
- Being tested
- Prevention program
- Keywords
- suicide, alcohol, marijuana, HIV, prevention, adolescent
- Medical subject headings
- Suicide, Alcoholism, Substance-Related Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Prevention program |
| Assessment Only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: change from baseline to 12 months (prior 3 months)
Secondary outcomes (21)
frequency of parental monitoring behavior
This was assessed with the Parental Monitoring Questionnaire
Measured: change from baseline to 1 month
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
Measured: change from baseline to 1 month
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
Measured: change from baseline to 1 month
adolescent perception of degree of interpersonal coping and stress management skills
This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version
Measured: change from baseline to 6 months
adolescent degree of perceived self-efficacy for condom use
This was assessed with the Self-Efficacy for Condom Use Scale
Measured: change from baseline to 1 month
adolescent degree of HIV related knowledge
This was assessed with the HIV Knowledge Scale
Measured: change from baseline to 1 month
adolescent perceptions of degree of peer substance use and tolerance of use
This was assessed with Peer Substance Use and Tolerance of Use scale
Measured: change from baseline to 6 months
adolescent perception of the degree of peer approval of sexual activity
This was assessed with the Peer Norms Scale for Sexual Activity scale
Measured: change from baseline to 6 months
adolescent degree of perceived self-efficacy for HIV prevention
This was assessed with the Self-Efficacy for HIV Prevention Scale
Measured: change from baseline to 1 month
frequency of positive and negative thoughts related to suicide
This was assessed with the Positive and Negative Suicide Ideation Inventory
Measured: change from baseline to 1 month
degree of adolescent positive/negative attitudes and beliefs about alcohol
This was assessed with the Youth Alcohol and Drug Survey
Measured: change from baseline to 1 month
degree of adolescent positive/negative attitudes and beliefs about marijuana use
This was assessed with the Youth Alcohol and Drug Survey
Measured: change from baseline to 1 month
frequency of parental monitoring behavior
This was assessed with the parental monitoring questionnaire
Measured: change from baseline to 6 months
frequency of parental monitoring behavior
This was assessed with the parental monitoring questionnaire
Measured: change from baseline to 12 months
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
Measured: change from baseline to 6 months
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
Measured: change from baseline to 12 months
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
Measured: change from baseline to 6 months
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
Measured: change from baseline to 12 months
adolescent perception of degree of interpersonal and stress management coping skills
This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version
Measured: change from baseline to 12 months
adolescent perceptions of degree of peer substance use and approval of use
This was assessed with Peer Substance Use and Tolerance of Use scale
Measured: change from baseline to 12 months
adolescent perception of the degree of peer approval of sexual activity
This was assessed with the Peer Norms Scale for Sexual Activity scale
Measured: change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startSep 2008
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Christianne Esposito-Smythers, Ph.D., Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228044
- Sponsor's protocol ID
- 5970
- Other IDs
- R01AA016854
- Status last verified
- Aug 2014
- First submitted
- 25 Aug 2014
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27883927
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol, Suicide, and HIV Prevention for Teens in Mental Health Treatment
- ClinicalTrials.gov ID
- NCT02228044
- Acronym / sponsor ID
- 5970
- Conditions
- Suicide, Alcohol Abuse, Drug Abuse, HIV
- Keywords
- suicide, alcohol, marijuana, HIV, prevention, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention Program | Experimental | Behavioral: Prevention programThis is a cognitive-behavioral substance abuse, suicide, and HIV prevention program delivered in a workshop format to adolescent participants and their parents/legal guardians. |
| Assessment Only | No intervention | – |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Active Alcohol or Marijuana Dependence Diagnosis
- HIV infection
- Pregnant
- Current psychosis
- Cognitively unable to give assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention program | Behavioural | Prevention Program |
Primary outcome
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
21 secondary outcomes
frequency of parental monitoring behavior
Time frame: change from baseline to 1 month
quality of parent-child communication around high risk behaviors
Time frame: change from baseline to 1 month
adolescent perceptions of parental degree of disapproval of high risk behavior
Time frame: change from baseline to 1 month
adolescent perception of degree of interpersonal coping and stress management skills
Time frame: change from baseline to 6 months
adolescent degree of perceived self-efficacy for condom use
Time frame: change from baseline to 1 month
adolescent degree of HIV related knowledge
Time frame: change from baseline to 1 month
adolescent perceptions of degree of peer substance use and tolerance of use
Time frame: change from baseline to 6 months
adolescent perception of the degree of peer approval of sexual activity
Time frame: change from baseline to 6 months
adolescent degree of perceived self-efficacy for HIV prevention
Time frame: change from baseline to 1 month
frequency of positive and negative thoughts related to suicide
Time frame: change from baseline to 1 month
degree of adolescent positive/negative attitudes and beliefs about alcohol
Time frame: change from baseline to 1 month
degree of adolescent positive/negative attitudes and beliefs about marijuana use
Time frame: change from baseline to 1 month
frequency of parental monitoring behavior
Time frame: change from baseline to 6 months
frequency of parental monitoring behavior
Time frame: change from baseline to 12 months
quality of parent-child communication around high risk behaviors
Time frame: change from baseline to 6 months
quality of parent-child communication around high risk behaviors
Time frame: change from baseline to 12 months
adolescent perceptions of parental degree of disapproval of high risk behavior
Time frame: change from baseline to 6 months
adolescent perceptions of parental degree of disapproval of high risk behavior
Time frame: change from baseline to 12 months
adolescent perception of degree of interpersonal and stress management coping skills
Time frame: change from baseline to 12 months
adolescent perceptions of degree of peer substance use and approval of use
Time frame: change from baseline to 12 months
adolescent perception of the degree of peer approval of sexual activity
Time frame: change from baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
- Derived from this study: PubMed 27883927Esposito-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christianne Esposito-Smythers, Ph.D. principal investigator
George Mason University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention program in people with Suicide and Alcohol Abuse, run by George Mason University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02228044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2014.