Mental Health Wellness 1SEENNCT05899218
Sexual and Gender Minority Emerging Adults Eliciting Narratives
A study testing Critical Narrative Development in people with Mental Health Wellness 1 and Sexual Orientation, run by University of Pennsylvania at 1 site in United States.
Trial summary
Critical narrative interventions (CNIs) have not been examined for addressing psychological outcomes (e.g., depression, anxiety, self-esteem, empowerment, psychological well-being) within sexual and gender minority emerging adults (SGM EA) of color; therefore, this pilot study will examine the use of CNIs to impact… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Sexual Orientation, Gender Identity
- What is being tested?
- Critical Narrative Development
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 1 Apr 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- identify as a sexual minority
- live in the United States
- identify as a person of color
- be aged 18-24 years
- have a smartphone and or computer access
- identify as living with moderate to severe depression as indicated on the PHQ-9 (score of 10 or higher)
- do not report suicidal ideation in the past month.
Who cannot join
- Identifies as a cisgender heterosexual man or woman
- Does not live in the United States
- Identifies as non-Hispanic white or Caucasian
- Is not between the ages of 18-24 years (inclusive)
- Does not have access to a smartphone or computer
- Plan to move out of the region for the next six months
Show all 10Show fewer
- Does not consent to study procedures
- Meets criteria for an unmanaged psychotic disorder
- meets criteria for none to mild depression on the PHQ-9 (score of 9 or less)
- reports suicidal ideation in the past month
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Nursing, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Sexual and Gender Minority Emerging Adults Eliciting Narratives (SEEN)
Critical narrative interventions (CNIs) have not been examined for addressing psychological outcomes (e.g., depression, anxiety, self-esteem, empowerment, psychological well-being) within sexual and gender minority emerging adults (SGM EA) of color; therefore, this pilot study will examine the use of CNIs to impact SGM of color psychological outcomes. Prior literature has shown that CNIs have the potential to increase empowerment, self-efficacy, and social support as a prevention strategy for mental health. The research study is being conducted to see if telling your story through photographs or video can improve the mental health and well-being of emerging adults that identify as a member of a sexual and/or gender minority and a racial and/or ethnic minority.
Participants will be asked to complete the following research procedures:
- take a survey online (about 20-30 minutes), then an interview about everyday experiences as sexual/gender minority of color and your experiences in seeking out mental health services.
- After the interview, participants will have one month to tell their story, answering two prompts "Tell us a time you have felt seen" and "Tell us a time when you have felt unseen." You will be randomized to one of two formats of telling your story: taking photographs or making two short videos.
- Photographs: Those that are randomized to the photograph condition will be asked to take 12 photos total telling your story and answering the prompt.
- Videos: Those that are randomized to the video condition will be asked to create two (1-3 minute) videos telling your story and answering the prompts.
- At the one-month time frame, participants will be asked to fill out another survey (about 20-30 minutes) and then complete an interview about the photos or videos created.
Read the detailed description
The research activities involve a two-arm pilot enrolling a sample of 30 participants who identify as sexual and gender minority (SGM), racial/ethnic minority/person of color (POC), and living with moderate to severe depression. After consent and completion of the baseline survey (15-20 min) and interview (45-60 min), participants will be randomized into one of two critical narrative interventions: photo-novella (n=15) or digital storytelling (n=15).
All participants will be given the same two prompts for their narrative intervention asking, "Share an experience of when you have felt seen as an SGM Person of Color in Philadelphia." AND "share an experience of when you have felt unseen as an SGM person of color in Philadelphia."
Photo-Novella: Participants in the photo-novella intervention will be asked to tell their story through 12 photographs and a caption (6 for the first prompt and 6 for the second prompt). Participants will be instructed to take a photograph answering the two prompts. Participants may use their smartphones or digital camera to capture their photographs. Participants may also edit their photographs using photo-editing software for aesthetics. Participants will also be asked to provide a short caption (no more than two sentences) explaining their photograph and provide a title for their work. Participants will be provided with a basic guide on photography and how to "snap a picture."
Digital Story: Participants in the digital storytelling intervention will be asked to tell their story in 3-6 minutes (two videos total, 1-3 minutes each) utilizing a video format that can include still or moving images, sound, music, and voiceover. Participants will be provided with a guide on software or applications that they can use to create their stories. Participants will be provided with a manual or basic guide to digital stories for their reference. Participants will be provided with guidance on expectations of the video, including format, length, quality, and closed captions for accessibility.
At the baseline visit after the survey and interview, participants will be randomized into one of the two intervention conditions (photo-novella or digital story). Once the participant is randomized, they will be provided with the electronic manual (based on their intervention). The research team member will provide guidance on what to expect (i.e., how many photos to take and what the prompt is) and go over the manual with the participant. The participant will then be given the opportunity to ask questions.
The participants will be given one month to complete their narrative and be asked to digitally submit their work to the research team during the 1-month visit. Participants will also be given the opportunity to present their work at a gallery (but not required to), which will be scheduled later (about ten months from the date of the first enrollment). The gallery and participation in the gallery are entirely voluntary and will not affect participation in the study.
A week before the scheduled 1-month follow-up, a research team member will reach out to the participant to confirm the 1-month study visit via phone, e-mail, or text as indicated in the participant's preferred contact method. A research team member will reach out every two days for confirmation until received from the participant.
Participants will receive a link via email a day before their one-month follow-up visit to complete a follow-up survey (15-20 mins). During the one-month follow-up, a research team member virtually on Zoom will conduct a follow-up interview (45-60 mins) asking participants about their experience of creating their critical narrative piece. At the one-month follow-up, research team members will review the final critical narratives of the participants digitally. Two days before the one-month follow-up, participants will receive a link via email to a Box folder (that is HIPAA compliant) where they can upload their photos/videos.
The participants will be notified of the gallery date and invited to attend. The gallery is optional and does not impact participation in the study.
- Being tested
- Critical Narrative Development
- Keywords
- racial/ethnic identity, intersectionality, mental health treatment seeking, intervention, narrative
- Medical subject headings
- Sexual Behavior, Intersectional Framework, Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical Narrative DevelopmentBehavioural
Participants are asked to answer two prompts ("describe an experience where you have felt seen as an LGBTQ+ person of color" and "describe an experience where you have felt unseen as an LGBTQ+ person of color").
| Study group | Role | What they receive |
|---|---|---|
| Photo-Novella | Experimental | Participants in the photo-novella intervention will be asked to take 12 photographs and write a caption for each photo based on two prompts. Receives: Behavioral: Critical Narrative Development |
| Digital Storytelling | Experimental | Participants in the digital storytelling intervention will be asked to create two videos (1-3 minutes each) based on two prompts. Receives: Behavioral: Critical Narrative Development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
scores range from 0 to 27, higher scores indicate higher levels of depression severity.
Measured: 1 month
Generalized Anxiety Disorder-7 (GAD-7)
scores range from 0 to 21, higher scores indicate higher levels of anxiety severity.
Measured: 1 month
The Flourishing Scale
scores range from 8 to 56, higher scores represent an individual with many psychological resources and strengths.
Measured: 1 month
Rosenberg Self-Esteem Scale
scores range from 8 to 56, higher scores represent an individual with higher self-esteem.
Measured: 1 month
Secondary outcomes (7)
Internalized Stigma of Mental Illness Scale (ISMI-9)
scores range from 1 to 4, higher scores represent higher internalized stigma towards mental illness.
Measured: 1 month
LGBTQ+ POC Microaggressions Scale-Brief (LGBTQ+ PCMS-B): Racism in Dating Subscale
scores range from 0 to 20 for each subscale, higher scores represent higher levels of racism in LGBT community, Heterosexism in Racial/ethnic community, and racism in dating/relationship.
Measured: 1 month
Attitudes Toward Mental Health Treatment (ATMHT) Scale
scores range from 20 to 80, higher scores represent more positive attitudes towards mental health treatment seeking.
Measured: 1 month
General Belongingness Scale (GBS): Sense of Acceptance Sub Scale
scores range from 12 to 84, higher scores represent higher sense of belonging.
Measured: 1 month
Multidimensional Scale of Perceived Social Support (MSPSS)
scores range from 1 to 7, higher scores represent higher perceived social support.
Measured: 1 month
Intersectional Discrimination Index -Anticipated Discrimination (InDI-A)
scores range from 0 to 4, higher scores represent higher anticipated intersectional discrimination
Measured: 1 Month
The Queer People of Color Identity Affirmation Scale (QPIAS): Identity Based Growth Subscale
two subscales, identity based growth with scores from 7 to 49 with higher scores representing higher growth, and identity cohesion with scores from 5 to 35 with higher scores as higher identity cohesion
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start17 Jul 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Tran, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899218
- Sponsor's protocol ID
- 853689
- Acronym
- SEEN
- Status last verified
- Oct 2024
- First submitted
- 19 May 2023
- Last updated
- 25 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the completion of the study, we plan to share with other researchers the de-identified individual participant data (IPD). This will only include the quantitative survey data collected and baseline and follow-up.