The Digital Wellbeing Project
Piloting a Web App for Sexual and Gender Minority Youth Mental Health
1 other identifier
interventional
270
1 country
1
Brief Summary
This goal of this randomized control trial is to test whether a web application that provides sexual and gender minority youth ages 13-19 (N=200) with tools for affirming their identities and coping with minority stress can affect key psychosocial outcomes, such as coping self-efficacy and symptoms of anxiety and depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2021
CompletedStudy Start
First participant enrolled
September 15, 2021
CompletedFirst Posted
Study publicly available on registry
September 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedResults Posted
Study results publicly available
June 5, 2023
CompletedJune 5, 2023
June 1, 2023
3 months
September 14, 2021
July 20, 2022
June 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Coping Self-efficacy
The Stress Appraisals Measure for Adolescents includes three subscales (Challenge subscale; Threat subscale; Resources subscale). Each of these subscales is answered on a 5-point scale (1=strongly disagree to 5=strongly agree). A mean score was computed for each subscale, with higher values indicating greater endorsement of each respective stress appraisal.
4-week follow-up
Secondary Outcomes (6)
Identity Affirmation
4-week follow-up
Internalization of Minority Stress
4-week follow-up
Sense of Belonging to the Queer Community
4-week follow-up
Anxiety Symptoms
4-week follow-up
Depression Symptoms
4-week follow-up
- +1 more secondary outcomes
Study Arms (2)
Online Resource website
ACTIVE COMPARATORThe comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.
immi
EXPERIMENTALThe intervention is a novel and scalable web application designed to provide sexual and gender minority youth with tools for affirming their identity and coping with minority stress.
Interventions
The intervention has four main content areas: 1) gender identity (the gender guide), 2) sexual orientation (the queerness guide), 3)stress and coping (the stress guide), and 4) internalized stigma (the internalized stigma guide).
The control will have access to resources on the website, but will not receive any engagement reminders, matching the conditions present in real world contexts in which web-based resource lists are available.
Eligibility Criteria
You may qualify if:
- Are between 13-19 years of age (inclusive)
- Self-identify as a sexual or gender minority
- Are English literate
- Reside within the United States
- Have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet
- Willingness to participate in study activities
You may not qualify if:
- Not between 13-19 years of age (inclusive)
- Does not self-identify as a sexual or gender minority
- Is not English literate
- Does not reside within the United States
- Does not have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet
- Unwilling to participate in study activities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- HopeLab Foundationcollaborator
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Bauermeister J, Choi SK, Bruehlman-Senecal E, Golinkoff J, Taboada A, Lavra J, Ramazzini L, Dillon F, Haritatos J. An Identity-Affirming Web Application to Help Sexual and Gender Minority Youth Cope With Minority Stress: Pilot Randomized Controlled Trial. J Med Internet Res. 2022 Aug 1;24(8):e39094. doi: 10.2196/39094.
PMID: 35916700DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jose Bauermeister
- Organization
- University of Pensylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Jose A Bauermeister, PhD
University of Pennsylvania
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
- SPONSOR
Study Record Dates
First Submitted
September 14, 2021
First Posted
September 30, 2021
Study Start
September 15, 2021
Primary Completion
December 23, 2021
Study Completion
July 1, 2022
Last Updated
June 5, 2023
Results First Posted
June 5, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset.
- Access Criteria
- The de-identified data from this project will be available through individual requests directed to the Principal Investigator.
Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset.