Clinical trial NCT03954535: Preventing Drug Abuse Among Sexual Minority Youth
Official title: Preventing Drug Abuse Among Sexual-Minority Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Keywords: sexual minorities
prevention
web-based intervention
substance use
longitudinal
randomized controlled trial
adolescence
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-05-17
Enrollment: 1216
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of times youth drank alcohol in the past month
timeFrame: an average of 5 months from study onset
measure: Number of times youth drank alcohol in the past month
timeFrame: 1-year follow-up
measure: Number of times youth drank alcohol in the past month
timeFrame: 2-year follow-up
measure: Number of times youth drank alcohol in the past month
timeFrame: 3-year follow-up
measure: Number of times youth binge drank in the past month
timeFrame: an average of 5 months from study onset
measure: Number of times youth binge drank in the past month
timeFrame: 1-year follow-up
measure: Number of times youth binge drank in the past month
timeFrame: 2-year follow-up
measure: Number of times youth binge drank in the past month
timeFrame: 3-year follow-up
measure: Number of times youth smoked cigarettes in the past month
timeFrame: an average of 5 months from study onset
measure: Number of times youth smoked cigarettes in the past month
timeFrame: 1-year follow-up
measure: Number of times youth smoked cigarettes in the past month
timeFrame: 2-year follow-up
measure: Number of times youth smoked cigarettes in the past month
timeFrame: 3-year follow-up
measure: Number of times youth smoked marijuana in the past month
timeFrame: an average of 5 months from study onset
measure: Number of times youth smoked marijuana in the past month
timeFrame: 1-year follow-up
measure: Number of times youth smoked marijuana in the past month
timeFrame: 2-year follow-up
measure: Number of times youth smoked marijuana in the past month
timeFrame: 3-year follow-up
measure: Number of times youth vaped any substance in the past month
timeFrame: an average of 5 months from study onset
measure: Number of times youth vaped any substance in the past month
timeFrame: 1-year follow-up
measure: Number of times youth vaped any substance in the past month
timeFrame: 2-year follow-up
measure: Number of times youth vaped any substance in the past month
timeFrame: 3-year follow-up
measure: Number of times youth used hard drugs in the past month
timeFrame: an average of 5 months from study onset
measure: Number of times youth used hard drugs in the past month
timeFrame: 1-year follow-up
measure: Number of times youth used hard drugs in the past month
timeFrame: 2-year follow-up
measure: Number of times youth used hard drugs in the past month
timeFrame: 3-year follow-up
Secondary outcomes:
measure: Mean scores for Goal Setting
timeFrame: an average of 5 months from study onset
measure: Mean scores for Goal Setting
timeFrame: 1-year follow-up
measure: Mean scores for Goal Setting
timeFrame: 2-year follow-up
measure: Mean scores for Goal Setting
timeFrame: 3-year follow-up
measure: Mean scores for Problem Solving
timeFrame: an average of 5 months from study onset
measure: Mean scores for Problem Solving
timeFrame: 1-year follow-up
measure: Mean scores for Problem Solving
timeFrame: 2-year follow-up
measure: Mean scores for Problem Solving
timeFrame: 3-year follow-up
measure: Mean scores for Self-Esteem
timeFrame: an average of 5 months from study onset
measure: Mean scores for Self-Esteem
timeFrame: 1-year follow-up
measure: Mean scores for Self-Esteem
timeFrame: 2-year follow-up
measure: Mean scores for Self-Esteem
timeFrame: 3-year follow-up
measure: Mean scores for Perceived Stress
timeFrame: an average of 5 months from study onset
measure: Mean scores for Perceived Stress
timeFrame: 1-year follow-up
measure: Mean scores for Perceived Stress
timeFrame: 2-year follow-up
measure: Mean scores for Perceived Stress
timeFrame: 3-year follow-up
measure: Mean scores for Coping
timeFrame: an average of 5 months from study onset
measure: Mean scores for Coping
timeFrame: 1-year follow-up
measure: Mean scores for Coping
timeFrame: 2-year follow-up
measure: Mean scores for Coping
timeFrame: 3-year follow-up
measure: Mean scores for Peer Drug use
timeFrame: an average of 5 months from study onset
measure: Mean scores for Peer Drug use
timeFrame: 1-year follow-up
measure: Mean scores for Peer Drug use
timeFrame: 2-year follow-up
measure: Mean scores for Peer Drug use
timeFrame: 3-year follow-up
measure: Mean scores for Self-Efficacy
timeFrame: an average of 5 months from study onset
measure: Mean scores for Self-Efficacy
timeFrame: 1-year follow-up
measure: Mean scores for Self-Efficacy
timeFrame: 2-year follow-up
measure: Mean scores for Self-Efficacy
timeFrame: 3-year follow-up
measure: Mean scores for Drug Refusal Skills
timeFrame: an average of 5 months from study onset
measure: Mean scores for Drug Refusal Skills
timeFrame: 1-year follow-up
measure: Mean scores for Drug Refusal Skills
timeFrame: 2-year follow-up
measure: Mean scores for Drug Refusal Skills
timeFrame: 3-year follow-up
measure: Mean scores for Assertiveness
timeFrame: an average of 5 months from study onset
measure: Mean scores for Assertiveness
timeFrame: 1-year follow-up
measure: Mean scores for Assertiveness
timeFrame: 2-year follow-up
measure: Mean scores for Assertiveness
timeFrame: 3-year follow-up
measure: Mean scores for Consequences of Substance Use
timeFrame: an average of 5 months from study onset
measure: Mean scores for Consequences of Substance Use
timeFrame: 1-year follow-up
measure: Mean scores for Consequences of Substance Use
timeFrame: 2-year follow-up
measure: Mean scores for Consequences of Substance Use
timeFrame: 3-year follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Traci M. Schwinn, PhD
role: PRINCIPAL_INVESTIGATOR
References: