The Digital Wellbeing Project

June 1, 2023 updated by: University of Pennsylvania

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4-week follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
4-week follow-up
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
4-week follow-up
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-week follow-up
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.
4-week follow-up
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.
4-week follow-up
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.
4-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HopeLab Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jose A Bauermeister, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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