The Digital Wellbeing Project

Piloting a Web App for Sexual and Gender Minority Youth Mental Health

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.

Study Overview

• Status: Completed
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: Control; Behavioral: immi

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Are between 13-19 years of age (inclusive)
2. Self-identify as a sexual or gender minority
3. Are English literate
4. Reside within the United States
5. Have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet
6. Willingness to participate in study activities

Exclusion Criteria:

1. Not between 13-19 years of age (inclusive)
2. Does not self-identify as a sexual or gender minority
3. Is not English literate
4. Does not reside within the United States
5. Does not have access to a device that has internet access, a web browser, and SMS capabilities, such as a smartphone, computer, or tablet
6. Unwilling to participate in study activities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Online Resource website; The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.	Behavioral: Control; 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.
Experimental: immi; The 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.	Behavioral: immi; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identity Affirmation	The Lesbian, Gay and Bisexual Positive Identity Measure-Authenticity Subscale has a scoring range from 1 to 7 (1=strongly disagree to 7=strongly agree). A mean score was computed, whereby greater values indicate greater feelings of authenticity.	4-week follow-up
Internalization of Minority Stress	The Coping with Discrimination Scale- Internalization Subscale has a scoring range from 1 to 6 (1=never to 6=always). We computed a mean score, where higher scores indicate greater internalization of blame for minority stress	4-week follow-up
Sense of Belonging to the Queer Community	The Thwarted Belongingness subscale of the Interpersonal Needs Questionnaire is a 5-item scale that is answered on a 7-point scale (1=not at all true" to 7=very true for me). We computed a sum score ranging from 5 to 35, where higher scores indicate a lack of sense of belonging	4-week follow-up
Anxiety Symptoms	The General Anxiety Disorder-7 scale has a range from 0 to 21. Scores were computed by summing the items. Higher scores indicate greater anxiety symptomatology.	4-week follow-up
Depression Symptoms	The Patient Health Questionnaire-8 inventory has a range from 0 to 24. A summed score was computed, where higher scores indicate greater depression symptomatology.	4-week follow-up
Cognitive and Behavioral Coping Skills	The Brief COPE inventory is comprised of 11 subscales: Self-distraction; Active coping; Emotional support; Instrumental support; Venting; Positive reframing; Planning; Acceptance; Self-blame; Substance use; and, Behavioral disengagement. Participants answered each subscale using a 4-point scale (1="I haven't been doing this at all" to 4="I've been doing this a lot"). A mean score was computed for each subscale, with higher values indicating greater use of that coping skill.	4-week follow-up

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: HopeLab Foundation
• Investigators: Principal Investigator: Jose A Bauermeister, PhD, University of Pennsylvania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): December 23, 2021
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Sexual and Gender Minorities
• Other Study ID Numbers: 849509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset.
• IPD Sharing 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.
• IPD Sharing Access Criteria: The de-identified data from this project will be available through individual requests directed to the Principal Investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No