The Digital Wellbeing Project

Not Applicable

Completed

• Conditions: Mental Health
• Interventions: Behavioral: immi; Behavioral: Control

• Registration Number: NCT05061966
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-14
• Study Start: 2021-09-15
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-09-30
• Primary Completion: 2021-12-23
• Study Completion: 2022-07-01
• Results First Submitted: 2022-07-20
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-01
• Last Update Submitted: 2023-06-01
• Results First Posted: 2023-06-05
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immi	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.
Online Resource website	Control	The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.

Primary Outcome Measures

Name	Time	Method
Coping Self-efficacy	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 Outcome Measures

Name	Time	Method
Identity Affirmation	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.
Anxiety Symptoms	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.
Sense of Belonging to the Queer Community	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
Depression Symptoms	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.
Internalization of Minority Stress	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
Cognitive and Behavioral Coping Skills	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States