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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,216
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.
Access to the website with entertainment features and resources - but no session content.
Columbia University Irving Medical Center
New York, New York, United States
Average 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.
Time frame: an average of 5 months from study onset
Average 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.
Time frame: 1-year follow-up
Average 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.
Time frame: 2-year follow-up
Average 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.
Time frame: 3-year follow-up
Average 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.
Time frame: an average of 5 months from study onset
Average 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.
Time frame: 1-year follow-up
Average 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.
Time frame: 2-year follow-up
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Average 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.
Time frame: 3-year follow-up
Average 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.
Time frame: an average of 5 months from study onset
Average 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.
Time frame: 1-year follow-up
Average 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.
Time frame: 2-year follow-up
Average 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.
Time frame: 3-year follow-up
Average 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.
Time frame: an average of 5 months from study onset
Average 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.
Time frame: 1-year follow-up
Average 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.
Time frame: 2-year follow-up
Average 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.
Time frame: 3-year follow-up
Average 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.
Time frame: an average of 5 months from study onset
Average 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.
Time frame: 1-year follow-up
Average 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.
Time frame: 2-year follow-up
Average 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.
Time frame: 3-year follow-up
Average 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.
Time frame: an average of 5 months from study onset
Average 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.
Time frame: 1-year follow-up
Average 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.
Time frame: 2-year follow-up
Average 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.
Time frame: 3-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. All items are averaged to yield a total score that ranges from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = low goal setting to 3 = higher goal setting; higher scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = high problem solving to 4 = low problem solving; lower scores indicate a better outcome. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = higher self-esteem to 4 = lower self-esteem; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = low perceived stress to 5 = high perceived stress; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = low perceived stress to 5 = high perceived stress; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = low perceived stress to 5 = high perceived stress; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = low perceived stress to 5 = high perceived stress; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = high coping skills to 3 = poor coping skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = no peer use to 3 = all peers use; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = high self-efficacy to 4 = low self-efficacy; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = high refusal skills to 5 = poor refusal skills; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 3-year follow-up
Mean Scores for Assertiveness
The assertiveness scale is a 3-item measure assessing how well youth believe they assert themselves. All items are averaged to yield a total score that ranges from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 1-year follow-up
Mean Scores for Assertiveness
The assertiveness scale is a 3-item measure assessing how well youth believe they assert themselves. All items are averaged to yield a total score that ranges from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 2-year follow-up
Mean Scores for Assertiveness
The assertiveness scale is a 3-item measure assessing how well youth believe they assert themselves. All items are averaged to yield a total score that ranges from 1 = low assertiveness to 5 = high assertiveness; higher scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 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. All items are averaged to yield a total score that ranges from 0 = zero times to 10 = ten or more times; lower scores indicate better outcomes. The mean total score for all participants in each arm will be calculated and reported.
Time frame: 3-year follow-up