The Digital Wellbeing Project

Study Overview
=================
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.

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

Conditions
-----------------
Mental Health

Intervention / Treatment
-----------------
* Behavioral: immi
* Behavioral: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sexual and Gender Minorities