Substance AbuseNCT03954535
Preventing Drug Abuse Among Sexual Minority Youth
A study testing Free2b in people with Substance Abuse, run by Columbia University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Free2b
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,216 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 30 Mar 2024
- Phase
- Interventional
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 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Lives outside the United States of America
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Preventing Drug Abuse Among Sexual-Minority Youth
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).
Read the detailed description
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.
- Conditions
- Substance Abuse
- Being tested
- Free2b, Attention-Placebo
- Keywords
- sexual minorities, prevention, web-based intervention, substance use, longitudinal, randomized controlled trial, adolescence
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free2bBehavioural
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.
Attention-PlaceboBehavioural
Access to the website with entertainment features and resources - but no session content.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 9 sessions and website with entertainment features and resources Receives: Behavioral: Free2b |
| Control | Placebo comparator | website with entertainment features and resources Receives: Behavioral: Attention-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2-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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-year follow-up
Secondary outcomes (40)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start15 Jan 2020
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Traci M. Schwinn, Columbia University
- Investigators
- Traci M. Schwinn, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954535
- Sponsor's protocol ID
- AAAR5072
- Other IDs
- R01DA043512
- Status last verified
- Aug 2025
- First submitted
- 14 May 2019
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weisblum M, Trussell E, Schwinn T, Pacheco AR, Nurkin P. Screening and Retaining Adolescents Recruited Through Social Media: Secondary Analysis from a Longitudinal Clinical Trial. JMIR Pediatr Parent. 2024 Feb 28;7:e47984. doi: 10.2196/47984.
PubMed 38416559