Preventing Drug Abuse Among Sexual Minority Youth

Not Applicable

Completed

• Conditions: Substance Abuse
• Interventions: Behavioral: Attention-Placebo; Behavioral: Free2b

• Registration Number: NCT03954535
• Lead Sponsor: Columbia University

Brief 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).

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Study Start: 2020-01-15
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1216

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Attention-Placebo	website with entertainment features and resources
Intervention	Free2b	9 sessions and website with entertainment features and resources

Primary Outcome Measures

Name	Time	Method
Number of times youth binge drank in the past month	3-year follow-up	Participants will be asked to report the numbers of times they have used the substance in the past month.
Number of times youth vaped any substance in the past month	3-year follow-up	Participants will be asked to report the numbers of times they have used the substance in the past month.
Number of times youth used hard drugs in the past month	3-year follow-up	Participants will be asked to report the numbers of times they have used the substance in the past month.
Number of times youth smoked cigarettes in the past month	3-year follow-up	Participants will be asked to report the numbers of times they have used the substance in the past month.
Number of times youth drank alcohol in the past month	3-year follow-up	Participants will be asked to report the numbers of times they have used the substance in the past month.
Number of times youth smoked marijuana in the past month	3-year follow-up	Participants will be asked to report the numbers of times they have used the substance in the past month.

Secondary Outcome Measures

Name	Time	Method
Mean scores for Problem Solving	3-year follow-up	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.
Mean scores for Self-Esteem	3-year follow-up	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.
Mean scores for Self-Efficacy	3-year follow-up	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.
Mean scores for Drug Refusal Skills	3-year follow-up	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.
Mean scores for Consequences of Substance Use	3-year follow-up	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.
Mean scores for Goal Setting	3-year follow-up	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.
Mean scores for Peer Drug use	3-year follow-up	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.
Mean scores for Assertiveness	3-year follow-up	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.
Mean scores for Perceived Stress	3-year follow-up	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.
Mean scores for Coping	3-year follow-up	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.

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States