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Preventing Drug Abuse Among Sexual Minority Youth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03954535
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Traci M. Schwinn, 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).

Condition or disease Intervention/treatment Phase
Substance Abuse Behavioral: Free2b Behavioral: Attention-Placebo Not Applicable

Detailed Description:

The randomized controlled trial will include 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 890 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Preventing Drug Abuse Among Sexual-Minority Youth
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of times youth drank alcohol in the past month [ Time Frame: an average of 5 months from study onset ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  2. Number of times youth drank alcohol in the past month [ Time Frame: 1-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  3. Number of times youth drank alcohol in the past month [ Time Frame: 2-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  4. Number of times youth drank alcohol in the past month [ Time Frame: 3-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  5. Number of times youth binge drank in the past month [ Time Frame: an average of 5 months from study onset ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  6. Number of times youth binge drank in the past month [ Time Frame: 1-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  7. Number of times youth binge drank in the past month [ Time Frame: 2-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  8. Number of times youth binge drank in the past month [ Time Frame: 3-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  9. Number of times youth smoked cigarettes in the past month [ Time Frame: an average of 5 months from study onset ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  10. Number of times youth smoked cigarettes in the past month [ Time Frame: 1-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  11. Number of times youth smoked cigarettes in the past month [ Time Frame: 2-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  12. Number of times youth smoked cigarettes in the past month [ Time Frame: 3-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  13. Number of times youth smoked marijuana in the past month [ Time Frame: an average of 5 months from study onset ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  14. Number of times youth smoked marijuana in the past month [ Time Frame: 1-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  15. Number of times youth smoked marijuana in the past month [ Time Frame: 2-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  16. Number of times youth smoked marijuana in the past month [ Time Frame: 3-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  17. Number of times youth vaped any substance in the past month [ Time Frame: an average of 5 months from study onset ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  18. Number of times youth vaped any substance in the past month [ Time Frame: 1-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  19. Number of times youth vaped any substance in the past month [ Time Frame: 2-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  20. Number of times youth vaped any substance in the past month [ Time Frame: 3-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  21. Number of times youth used hard drugs in the past month [ Time Frame: an average of 5 months from study onset ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  22. Number of times youth used hard drugs in the past month [ Time Frame: 1-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  23. Number of times youth used hard drugs in the past month [ Time Frame: 2-year follow-up ]
    Participants will be asked to report the numbers of times they have used the substance in the past month.

  24. Number of times youth used hard drugs in the past month [ Time Frame: 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 :
  1. Mean scores for Goal Setting [ Time Frame: an average of 5 months from study onset ]
    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. Mean scores for Goal Setting [ Time Frame: 1-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.

  3. Mean scores for Goal Setting [ Time Frame: 2-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.

  4. Mean scores for Goal Setting [ Time Frame: 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.

  5. Mean scores for Problem Solving [ Time Frame: an average of 5 months from study onset ]
    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.

  6. Mean scores for Problem Solving [ Time Frame: 1-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.

  7. Mean scores for Problem Solving [ Time Frame: 2-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.

  8. Mean scores for Problem Solving [ Time Frame: 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.

  9. Mean scores for Self-Esteem [ Time Frame: an average of 5 months from study onset ]
    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.

  10. Mean scores for Self-Esteem [ Time Frame: 1-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.

  11. Mean scores for Self-Esteem [ Time Frame: 2-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.

  12. Mean scores for Self-Esteem [ Time Frame: 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.

  13. Mean scores for Perceived Stress [ Time Frame: an average of 5 months from study onset ]
    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.

  14. Mean scores for Perceived Stress [ Time Frame: 1-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.

  15. Mean scores for Perceived Stress [ Time Frame: 2-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.

  16. Mean scores for Perceived Stress [ Time Frame: 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.

  17. Mean scores for Coping [ Time Frame: an average of 5 months from study onset ]
    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.

  18. Mean scores for Coping [ Time Frame: 1-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.

  19. Mean scores for Coping [ Time Frame: 2-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.

  20. Mean scores for Coping [ Time Frame: 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.

  21. Mean scores for Peer Drug use [ Time Frame: an average of 5 months from study onset ]
    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.

  22. Mean scores for Peer Drug use [ Time Frame: 1-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.

  23. Mean scores for Peer Drug use [ Time Frame: 2-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.

  24. Mean scores for Peer Drug use [ Time Frame: 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.

  25. Mean scores for Self-Efficacy [ Time Frame: an average of 5 months from study onset ]
    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.

  26. Mean scores for Self-Efficacy [ Time Frame: 1-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.

  27. Mean scores for Self-Efficacy [ Time Frame: 2-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.

  28. Mean scores for Self-Efficacy [ Time Frame: 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.

  29. Mean scores for Drug Refusal Skills [ Time Frame: an average of 5 months from study onset ]
    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.

  30. Mean scores for Drug Refusal Skills [ Time Frame: 1-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.

  31. Mean scores for Drug Refusal Skills [ Time Frame: 2-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.

  32. Mean scores for Drug Refusal Skills [ Time Frame: 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.

  33. Mean scores for Assertiveness [ Time Frame: an average of 5 months from study onset ]
    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.

  34. Mean scores for Assertiveness [ Time Frame: 1-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.

  35. Mean scores for Assertiveness [ Time Frame: 2-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.

  36. Mean scores for Assertiveness [ Time Frame: 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.

  37. Mean scores for Consequences of Substance Use [ Time Frame: an average of 5 months from study onset ]
    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.

  38. Mean scores for Consequences of Substance Use [ Time Frame: 1-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.

  39. Mean scores for Consequences of Substance Use [ Time Frame: 2-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.

  40. Mean scores for Consequences of Substance Use [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954535


Contacts
Layout table for location contacts
Contact: Traci M. Schwinn, PhD 212-851-2280 tms40@columbia.edu
Contact: Rachel Yamson 212-851-2266 rey2103@columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Traci M. Schwinn, PhD    212-851-2280    tms40@columbia.edu   
Sponsors and Collaborators
Columbia University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Traci M. Schwinn, PhD Columbia University

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Responsible Party: Traci M. Schwinn, Research Scientist in the Faculty of Social Work, Columbia University
ClinicalTrials.gov Identifier: NCT03954535    
Other Study ID Numbers: AAAR5072
R01DA043512 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Traci M. Schwinn, Columbia University:
sexual minorities
prevention
web-based intervention
substance use
longitudinal
randomized controlled trial
adolescence
Additional relevant MeSH terms:
Layout table for MeSH terms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders