The Digital Wellbeing Project

Sponsor
University of Pennsylvania (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05061966
Collaborator
HopeLab Foundation (Other)
300
1
2
9.5
31.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: immi
  • Behavioral: Control
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Piloting a Web App for Sexual and Gender Minority Youth Mental Health
Actual Study Start Date :
Sep 15, 2021
Actual Primary Completion Date :
Dec 23, 2021
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Coping self-efficacy [Changes between baseline and 4-week follow-up]

    The Stress Appraisals Measure for Adolescents includes three subscales answered on a 5-point scale. The Challenges subscale has scores ranging from 3 to 15, where higher scores indicate greater perceptions of stress as a surmountable challenge. The Threat subscale has scores ranging from 7 to 35, where higher scores indicate perceiving stress as more threatening. The Resources subscale has scores ranging from 3 to 15, with higher scores indicating greater perception of having the resources to cope with stress.

Secondary Outcome Measures

  1. Identity Affirmation [Changes between baseline and 4-week follow-up]

    The Lesbian, Gay and Bisexual Positive Identity Measure-Authenticity Subscale has a scoring range from 1 to 7, whereby greater values indicate greater feelings of authenticity.

  2. Internalization of minority stress [Changes between baseline and 4-week follow-up]

    The Coping with Discrimination Scale- Internalization Subscale has a scoring range from 1 to 6; higher scores indicate greater internalization of minority stress.

  3. Sense of belonging to the queer community [Changes between baseline and 4-week follow-up]

    The Lesbian, Gay and Bisexual Positive Identity Measure-Community Subscale has a scoring range from 1 to 7, where higher scores indicate greater feelings of connection to the LGBTQ community.

  4. Anxiety symptoms [Changes between baseline and 4-week follow-up]

    The General Anxiety Disorder-7 scale has a range from 0 to 21, where higher scores indicate greater anxiety symptomatology.

  5. Depression symptoms [Changes between baseline and 4-week follow-up]

    The Patient Health Questionnaire-8 inventory has a range from 0 to 24, where higher scores indicate greater depression symptomatology.

  6. Cognitive and Behavioral Coping Skills [Changes between baseline and 4-week follow-up]

    The Brief COPE inventory is comprised of 11 subscales. Each subscale is scored from 2 to 8. Higher values indicate a greater number of specific coping strategies.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • HopeLab Foundation

Investigators

  • Principal Investigator: Jose A Bauermeister, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05061966
Other Study ID Numbers:
  • 849509
First Posted:
Sep 30, 2021
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Pennsylvania

Study Results

No Results Posted as of Apr 26, 2022