NCT03954535

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 26, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

4.2 years

First QC Date

May 14, 2019

Results QC Date

July 25, 2025

Last Update Submit

August 22, 2025

Conditions

Substance Abuse

Keywords

sexual minoritiespreventionweb-based interventionsubstance uselongitudinalrandomized controlled trialadolescence

Outcome Measures

Primary Outcomes (24)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    3-year follow-up

Secondary Outcomes (40)

  • Mean Scores for Goal Setting

    an average of 5 months from study onset

  • Mean Scores for Goal Setting

    1-year follow-up

  • Mean Scores for Goal Setting

    2-year follow-up

  • Mean Scores for Goal Setting

    3-year follow-up

  • Mean Scores for Problem Solving

    an average of 5 months from study onset

  • +35 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

9 sessions and website with entertainment features and resources

Behavioral: Free2b

Control

PLACEBO COMPARATOR

website with entertainment features and resources

Behavioral: Attention-Placebo

Interventions

Free2bBEHAVIORAL

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.

Intervention
Attention-PlaceboBEHAVIORAL

Access to the website with entertainment features and resources - but no session content.

Control

Eligibility Criteria

Age15 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • \- Lives outside the United States of America

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 38416559DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Traci Schwinn
Organization
Columbia University School of Social Work
tms40@columbia.edu
212-851-2280

Study Officials

  • Traci M. Schwinn, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist in the Faculty of Social Work

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 17, 2019

Study Start

January 15, 2020

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

August 26, 2025

Results First Posted

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)