Preventing Drug Abuse Among Sexual Minority Youth

Study Overview
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Brief Summary
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The planned randomized clinical trial will longitudinally test a tailored, web-based drug abuse prevention program with a nationwide sample of 15- to 17-year-old sexual minority youth (youth who identify as gay, lesbian, bisexual, or unsure of their sexual orientation).

Detailed Description
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The randomized controlled trial will include at least 890 sexual-minority youth from the United States. Study participants will be 15- to 17-year-old youth recruited from Facebook/Instagram. All youth will complete pretest measures online. Intervention-arm youth will then interact with the 9-session program; youth in the control arm will have access to an attention-placebo website. All youth will then complete posttest measures (immediately following intervention completion and estimated to be approximately 5 months after study onset) and 1-, 2-, and 3-year follow-up measures. Across posttest and annual follow-up measurement occasions, data analyses will examine rates of 30-day drug use between study arms. The investigators will also examine intervention effects on mediator variables associated with drug use and assess the extent to which changes in mediator variables explain differences in drug use between arms. Youth assigned to the intervention arm will have access to 9 intervention sessions delivered online. The sessions will be housed on a website with entertainment features youth seek: life hacks, features on LGBTQ leaders, fortunes, horoscopes, inspiring quotes, and health-related resources. To ensure that youths' expectations for study participation are equivalent across arms and to account for the non-active components of the experimental intervention, the investigators designed the attention-placebo arm. Youth assigned to the attention-placebo arm will have access to the website with entertainment features: life hacks, features on LGBTQ leaders, fortunes, horoscopes, inspiring quotes, and health-related resources.

Official Title
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Preventing Drug Abuse Among Sexual-Minority Youth

Conditions
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Substance Abuse

Intervention / Treatment
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* Behavioral: Free2b
* Behavioral: Attention-Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: teenagers between the ages of 15-17 years old identify as lesbian, gay, bisexual, or unsure of sexual orientation speak and read English access to a private desktop, laptop, or tablet with broadband internet access Exclusion: - Lives outside the United States of America

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>9 sessions and website with entertainment features and resources | Behavioral: Free2b<br>* The intervention will consist of a website and 9 sessions. The intervention sessions will facilitate youths' acquisition of personal and social cognitive-behavioral skills. The intervention will focus on goal setting, decision making, enhancing self-worth, coping with stress, combating distorted thinking, communication skills, using alcohol and other drugs and a review session. Each session will require approximately 20 minutes and must be finished in a single sitting. Sessions will be delivered on a weekly basis. The website will include entertainment features and resources.<br>|
| Placebo Comparator: Control<br>website with entertainment features and resources | Behavioral: Attention-Placebo<br>* Access to the website with entertainment features and resources - but no session content.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of times youth drank alcohol in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | an average of 5 months from study onset | 
| Number of times youth drank alcohol in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 1-year follow-up | 
| Number of times youth drank alcohol in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 2-year follow-up | 
| Number of times youth drank alcohol in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 3-year follow-up | 
| Number of times youth binge drank in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | an average of 5 months from study onset | 
| Number of times youth binge drank in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 1-year follow-up | 
| Number of times youth binge drank in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 2-year follow-up | 
| Number of times youth binge drank in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 3-year follow-up | 
| Number of times youth smoked cigarettes in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | an average of 5 months from study onset | 
| Number of times youth smoked cigarettes in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 1-year follow-up | 
| Number of times youth smoked cigarettes in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 2-year follow-up | 
| Number of times youth smoked cigarettes in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 3-year follow-up | 
| Number of times youth smoked marijuana in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | an average of 5 months from study onset | 
| Number of times youth smoked marijuana in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 1-year follow-up | 
| Number of times youth smoked marijuana in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 2-year follow-up | 
| Number of times youth smoked marijuana in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 3-year follow-up | 
| Number of times youth vaped any substance in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | an average of 5 months from study onset | 
| Number of times youth vaped any substance in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 1-year follow-up | 
| Number of times youth vaped any substance in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 2-year follow-up | 
| Number of times youth vaped any substance in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 3-year follow-up | 
| Number of times youth used hard drugs in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | an average of 5 months from study onset | 
| Number of times youth used hard drugs in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 1-year follow-up | 
| Number of times youth used hard drugs in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 2-year follow-up | 
| Number of times youth used hard drugs in the past month | Participants will be asked to report the numbers of times they have used the substance in the past month. | 3-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean scores for Goal Setting | The goal setting scale is a 5-item measure assessing the degree to which youth set and work on goals. The mean score will be calculated. Index scores range from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. | an average of 5 months from study onset | 
| Mean scores for Goal Setting | The goal setting scale is a 5-item measure assessing the degree to which youth set and work on goals. The mean score will be calculated. Index scores range from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. | 1-year follow-up | 
| Mean scores for Goal Setting | The goal setting scale is a 5-item measure assessing the degree to which youth set and work on goals. The mean score will be calculated. Index scores range from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. | 2-year follow-up | 
| Mean scores for Goal Setting | The goal setting scale is a 5-item measure assessing the degree to which youth set and work on goals. The mean score will be calculated. Index scores range from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. | 3-year follow-up | 
| Mean scores for Problem Solving | The problem solving scale is an 8-item measure assessing the degree to which youth employ skills to solve problems. The mean score will be calculated. Index scores range from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. | an average of 5 months from study onset | 
| Mean scores for Problem Solving | The problem solving scale is an 8-item measure assessing the degree to which youth employ skills to solve problems. The mean score will be calculated. Index scores range from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. | 1-year follow-up | 
| Mean scores for Problem Solving | The problem solving scale is an 8-item measure assessing the degree to which youth employ skills to solve problems. The mean score will be calculated. Index scores range from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. | 2-year follow-up | 
| Mean scores for Problem Solving | The problem solving scale is an 8-item measure assessing the degree to which youth employ skills to solve problems. The mean score will be calculated. Index scores range from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. | 3-year follow-up | 
| Mean scores for Self-Esteem | The self-esteem scale is a 10-item measure assessing youths' feelings of self-worth and value. Means scores will be calculated. Index scores ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. | an average of 5 months from study onset | 
| Mean scores for Self-Esteem | The self-esteem scale is a 10-item measure assessing youths' feelings of self-worth and value. Means scores will be calculated. Index scores ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. | 1-year follow-up | 
| Mean scores for Self-Esteem | The self-esteem scale is a 10-item measure assessing youths' feelings of self-worth and value. Means scores will be calculated. Index scores ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. | 2-year follow-up | 
| Mean scores for Self-Esteem | The self-esteem scale is a 10-item measure assessing youths' feelings of self-worth and value. Means scores will be calculated. Index scores ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. | 3-year follow-up | 
| Mean scores for Perceived Stress | The perceived stress scale is an 8-item measure assessing the degree to which youth feel overwhelmed by stress. Mean scores will be calculated. Index score range from 0 = low perceived stress to 3 = high perceived stress; lower scores indicate better outcomes. | an average of 5 months from study onset | 
| Mean scores for Perceived Stress | The perceived stress scale is an 8-item measure assessing the degree to which youth feel overwhelmed by stress. Mean scores will be calculated. Index score range from 0 = low perceived stress to 3 = high perceived stress; lower scores indicate better outcomes. | 1-year follow-up | 
| Mean scores for Perceived Stress | The perceived stress scale is an 8-item measure assessing the degree to which youth feel overwhelmed by stress. Mean scores will be calculated. Index score range from 0 = low perceived stress to 3 = high perceived stress; lower scores indicate better outcomes. | 2-year follow-up | 
| Mean scores for Perceived Stress | The perceived stress scale is an 8-item measure assessing the degree to which youth feel overwhelmed by stress. Mean scores will be calculated. Index score range from 0 = low perceived stress to 3 = high perceived stress; lower scores indicate better outcomes. | 3-year follow-up | 
| Mean scores for Coping | The coping scale is a 6-item measure assessing the degree to which youth feel they can manage the difficulties in their life. Mean scores will be calculated. Index score range from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. | an average of 5 months from study onset | 
| Mean scores for Coping | The coping scale is a 6-item measure assessing the degree to which youth feel they can manage the difficulties in their life. Mean scores will be calculated. Index score range from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. | 1-year follow-up | 
| Mean scores for Coping | The coping scale is a 6-item measure assessing the degree to which youth feel they can manage the difficulties in their life. Mean scores will be calculated. Index score range from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. | 2-year follow-up | 
| Mean scores for Coping | The coping scale is a 6-item measure assessing the degree to which youth feel they can manage the difficulties in their life. Mean scores will be calculated. Index score range from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. | 3-year follow-up | 
| Mean scores for Peer Drug use | The peer drug use scale is a 7-item measuring that asks youth to indicate the number of close friends who have used various substances in the past month. Mean scores will be calculate. Index score range from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. | an average of 5 months from study onset | 
| Mean scores for Peer Drug use | The peer drug use scale is a 7-item measuring that asks youth to indicate the number of close friends who have used various substances in the past month. Mean scores will be calculate. Index score range from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. | 1-year follow-up | 
| Mean scores for Peer Drug use | The peer drug use scale is a 7-item measuring that asks youth to indicate the number of close friends who have used various substances in the past month. Mean scores will be calculate. Index score range from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. | 2-year follow-up | 
| Mean scores for Peer Drug use | The peer drug use scale is a 7-item measuring that asks youth to indicate the number of close friends who have used various substances in the past month. Mean scores will be calculate. Index score range from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. | 3-year follow-up | 
| Mean scores for Self-Efficacy | The self-efficacy scale is a 7-item measuring youths' perceived ability to handle difficult life situations. Mean scores will be calculated. Index score range from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. | an average of 5 months from study onset | 
| Mean scores for Self-Efficacy | The self-efficacy scale is a 7-item measuring youths' perceived ability to handle difficult life situations. Mean scores will be calculated. Index score range from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. | 1-year follow-up | 
| Mean scores for Self-Efficacy | The self-efficacy scale is a 7-item measuring youths' perceived ability to handle difficult life situations. Mean scores will be calculated. Index score range from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. | 2-year follow-up | 
| Mean scores for Self-Efficacy | The self-efficacy scale is a 7-item measuring youths' perceived ability to handle difficult life situations. Mean scores will be calculated. Index score range from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. | 3-year follow-up | 
| Mean scores for Drug Refusal Skills | The drug refusal scale is a 15-item measure assessing the likelihood of youth using various refusal strategies when offered to use alcohol, cigarettes, or marijuana. Means scores will be calculated. Index score range from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. | an average of 5 months from study onset | 
| Mean scores for Drug Refusal Skills | The drug refusal scale is a 15-item measure assessing the likelihood of youth using various refusal strategies when offered to use alcohol, cigarettes, or marijuana. Means scores will be calculated. Index score range from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. | 1-year follow-up | 
| Mean scores for Drug Refusal Skills | The drug refusal scale is a 15-item measure assessing the likelihood of youth using various refusal strategies when offered to use alcohol, cigarettes, or marijuana. Means scores will be calculated. Index score range from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. | 2-year follow-up | 
| Mean scores for Drug Refusal Skills | The drug refusal scale is a 15-item measure assessing the likelihood of youth using various refusal strategies when offered to use alcohol, cigarettes, or marijuana. Means scores will be calculated. Index score range from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. | 3-year follow-up | 
| Mean scores for Assertiveness | The assertiveness scale is a 3-item measure assessing how well youth believe they assert themselves. Mean scores will be calculated. Index score range from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. | an average of 5 months from study onset | 
| Mean scores for Assertiveness | The assertiveness scale is a 3-item measure assessing how well youth believe they assert themselves. Mean scores will be calculated. Index score range from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. | 1-year follow-up | 
| Mean scores for Assertiveness | The assertiveness scale is a 3-item measure assessing how well youth believe they assert themselves. Mean scores will be calculated. Index score range from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. | 2-year follow-up | 
| Mean scores for Assertiveness | The assertiveness scale is a 3-item measure assessing how well youth believe they assert themselves. Mean scores will be calculated. Index score range from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. | 3-year follow-up | 
| Mean scores for Consequences of Substance Use | The consequences of substance use scale is a 13-item measure assessing how often youths' substance use has caused them trouble with the law, family, friends, and academics. Mean scores will be calculated. Index score range from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. | an average of 5 months from study onset | 
| Mean scores for Consequences of Substance Use | The consequences of substance use scale is a 13-item measure assessing how often youths' substance use has caused them trouble with the law, family, friends, and academics. Mean scores will be calculated. Index score range from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. | 1-year follow-up | 
| Mean scores for Consequences of Substance Use | The consequences of substance use scale is a 13-item measure assessing how often youths' substance use has caused them trouble with the law, family, friends, and academics. Mean scores will be calculated. Index score range from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. | 2-year follow-up | 
| Mean scores for Consequences of Substance Use | The consequences of substance use scale is a 13-item measure assessing how often youths' substance use has caused them trouble with the law, family, friends, and academics. Mean scores will be calculated. Index score range from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. | 3-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sexual minorities, prevention, web-based intervention, substance use, longitudinal, randomized controlled trial, adolescence