Mental Health
Conditions
Keywords
Sexual and Gender Minorities
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.
Interventions
BEHAVIORALimmi
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).
BEHAVIORALControl
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.
Sponsors
HopeLab Foundation
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Online Resource Website The comparator is a website that includes a list of freely available web-based resources for sexual and gender minority youth.
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. | 135 |
| 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.
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). | 135 |
| Total | 270 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 13 |
Baseline characteristics
| Characteristic | Online Resource Website | Immi | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 120 Participants | 123 Participants | 243 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 12 Participants | 27 Participants |
| Age, Continuous | 16.42 years STANDARD_DEVIATION 1.51 | 16.56 years STANDARD_DEVIATION 1.46 | 16.49 years STANDARD_DEVIATION 1.49 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 31 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 104 Participants | 197 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 23 Participants | 26 Participants | 49 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 23 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 64 Participants | 54 Participants | 118 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 32 Participants | 60 Participants |
| Region of Enrollment United States | 135 participants | 135 participants | 270 participants |
| Sex: Female, Male Female | 103 Participants | 106 Participants | 209 Participants |
| Sex: Female, Male Male | 32 Participants | 29 Participants | 61 Participants |
| Sex/Gender, Customized Multiple gender identities | 56 Participants | 57 Participants | 113 Participants |
| Sex/Gender, Customized Single gender identity | 79 Participants | 78 Participants | 157 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 135 | 0 / 135 |
| other Total, other adverse events | 0 / 135 | 0 / 135 |
| serious Total, serious adverse events | 0 / 135 | 0 / 135 |
Outcome results
Primary
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.
Time frame: 4-week follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Resource Website | Coping Self-efficacy | Challenge | 3.32 score on a scale | Standard Deviation 0.93 |
| Online Resource Website | Coping Self-efficacy | Threat | 3.92 score on a scale | Standard Deviation 0.69 |
| Online Resource Website | Coping Self-efficacy | Resource | 3.67 score on a scale | Standard Deviation 0.9 |
| Immi | Coping Self-efficacy | Challenge | 3.64 score on a scale | Standard Deviation 0.85 |
| Immi | Coping Self-efficacy | Threat | 3.85 score on a scale | Standard Deviation 0.77 |
| Immi | Coping Self-efficacy | Resource | 3.83 score on a scale | Standard Deviation 0.92 |
Secondary
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.
Time frame: 4-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Resource Website | Anxiety Symptoms | 10.30 score on a scale | Standard Deviation 5.78 |
| Immi | Anxiety Symptoms | 9.92 score on a scale | Standard Deviation 5.56 |
Secondary
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.
Time frame: 4-week follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Resource Website | Cognitive and Behavioral Coping Skills | Instrumental support | 2.30 units on a scale | Standard Deviation 0.87 |
| Online Resource Website | Cognitive and Behavioral Coping Skills | Planning | 2.56 units on a scale | Standard Deviation 0.86 |
| Online Resource Website | Cognitive and Behavioral Coping Skills | Emotional support | 2.43 units on a scale | Standard Deviation 0.94 |
| Online Resource Website | Cognitive and Behavioral Coping Skills | Acceptance | 2.73 units on a scale | Standard Deviation 0.77 |
| Online Resource Website | Cognitive and Behavioral Coping Skills | Venting | 2.42 units on a scale | Standard Deviation 0.82 |
| Online Resource Website | Cognitive and Behavioral Coping Skills | Self-blame | 2.76 units on a scale | Standard Deviation 0.88 |
| Online Resource Website | Cognitive and Behavioral Coping Skills | Active coping | 2.47 units on a scale | Standard Deviation 0.72 |
| Online Resource Website | Cognitive and Behavioral Coping Skills | Substance use | 1.38 units on a scale | Standard Deviation 0.78 |
| Online Resource Website | Cognitive and Behavioral Coping Skills | Positive reframing | 2.25 units on a scale | Standard Deviation 0.78 |
| Online Resource Website | Cognitive and Behavioral Coping Skills | Behavioral disengagement | 1.99 units on a scale | Standard Deviation 0.82 |
| Online Resource Website | Cognitive and Behavioral Coping Skills | Self-distraction | 3.23 units on a scale | Standard Deviation 0.65 |
| Immi | Cognitive and Behavioral Coping Skills | Behavioral disengagement | 2.01 units on a scale | Standard Deviation 0.8 |
| Immi | Cognitive and Behavioral Coping Skills | Self-distraction | 3.23 units on a scale | Standard Deviation 0.65 |
| Immi | Cognitive and Behavioral Coping Skills | Active coping | 2.65 units on a scale | Standard Deviation 0.84 |
| Immi | Cognitive and Behavioral Coping Skills | Emotional support | 2.59 units on a scale | Standard Deviation 0.94 |
| Immi | Cognitive and Behavioral Coping Skills | Instrumental support | 2.64 units on a scale | Standard Deviation 0.9 |
| Immi | Cognitive and Behavioral Coping Skills | Venting | 2.48 units on a scale | Standard Deviation 0.86 |
| Immi | Cognitive and Behavioral Coping Skills | Positive reframing | 2.45 units on a scale | Standard Deviation 0.86 |
| Immi | Cognitive and Behavioral Coping Skills | Planning | 2.79 units on a scale | Standard Deviation 0.83 |
| Immi | Cognitive and Behavioral Coping Skills | Acceptance | 2.87 units on a scale | Standard Deviation 0.77 |
| Immi | Cognitive and Behavioral Coping Skills | Self-blame | 2.91 units on a scale | Standard Deviation 0.87 |
| Immi | Cognitive and Behavioral Coping Skills | Substance use | 1.33 units on a scale | Standard Deviation 0.74 |
Secondary
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.
Time frame: 4-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Resource Website | Depression Symptoms | 11.40 score on a scale | Standard Deviation 5.75 |
| Immi | Depression Symptoms | 11.61 score on a scale | Standard Deviation 5.95 |
Secondary
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.
Time frame: 4-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Resource Website | Identity Affirmation | 5.08 units on a scale | Standard Deviation 1.3 |
| Immi | Identity Affirmation | 5.10 units on a scale | Standard Deviation 1.33 |
Secondary
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
Time frame: 4-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Resource Website | Internalization of Minority Stress | 2.94 score on a scale | Standard Deviation 1.23 |
| Immi | Internalization of Minority Stress | 3.19 score on a scale | Standard Deviation 1.27 |
Secondary
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
Time frame: 4-week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Online Resource Website | Sense of Belonging to the Queer Community | 18.21 units on a scale | Standard Deviation 6.24 |
| Immi | Sense of Belonging to the Queer Community | 17.15 units on a scale | Standard Deviation 6.99 |