Preventing Drug Abuse Among Sexual Minority Youth

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Substance Abuse
• Intervention / Treatment: Behavioral: Free2b; Behavioral: Attention-Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 1216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 9 sessions and website with entertainment features and resources	Behavioral: Free2b; 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.
Placebo Comparator: Control; website with entertainment features and resources	Behavioral: Attention-Placebo; Access to the website with entertainment features and resources - but no session content.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Traci M. Schwinn, PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; prevention; adolescence; substance use; longitudinal; web-based intervention; sexual minorities
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: AAAR5072; R01DA043512 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No