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OpenTrials
Completed

NCT Number: NCT05061966

The Digital Wellbeing Project

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.

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Key information

Conditions

Mental Health Behavior Coitus Personal Satisfaction Psychological Well-Being Sexual Behavior

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

immi

Behavioral

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).

Control

Behavioral

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.

Primary outcomes

  1. Coping Self-efficacy

    Time frame: 4-week follow-up

    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.

Secondary outcomes

  1. Identity Affirmation

    Time frame: 4-week follow-up

    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.

  2. Internalization of Minority Stress

    Time frame: 4-week follow-up

    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

  3. Sense of Belonging to the Queer Community

    Time frame: 4-week follow-up

    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. Anxiety Symptoms

    Time frame: 4-week follow-up

    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.

  5. Depression Symptoms

    Time frame: 4-week follow-up

    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.

  6. Cognitive and Behavioral Coping Skills

    Time frame: 4-week follow-up

    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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • HopeLab Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 30, 2021
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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