Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04969003
Other study ID # 2000028980_a
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date April 20, 2022

Study information

Verified date May 2022
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purposes of this new study are to test among adolescent viewers the utility of brief video-based interventions to: 1. reduce transphobia; 2. reduce depression-related stigma and increase likelihood of treatment-seeking; and 3. examine the role of viewer's sex (male / female / non-binary), race (Black vs non-Black), and sexual orientation (straight vs LGBQ) as independent factors on the outcomes of interest.


Description:

Intervention videos will each be of ~100-second duration and feature four underage professionals (ages 16) acting as simulated patients. All videos will focus on an empowered presenter with depression sharing their personal story regarding depression. They will describe how social supports from family, friends, and community, as well as professional help assisted them in overcoming symptoms of the illness, as well as how being transgender may have had an impact on it. The four actors will include two males (one trans, one cis) and tow females (one trans, one cis). Assessments will occur at baseline and post-intervention, and will include: 1. Demographics (baseline only); 2. Primary outcome: a. Attitudes toward Transgender Men and Women (ATTMW) scale. 3. Secondary outcome: 1. Transgender attitudes: feelings thermometer, modeled after Norton et al 2013. 2. Depression-related stigma (Depression Stigma Scale [DSS]);and 3. Help-seeking (General Help-Seeking Questionnaire [GHSQ]). For each of study we intend to randomly assign ~1,000 individuals aged 14-18 as follows: Randomized, in equal proportions, and stratified by sex and race, to view one of four ~100-second videos: 1. Transgender male; 2. Cis-gender male); 3. Transgender female; 4. Cis-gender female.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date April 20, 2022
Est. primary completion date April 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria: - English-speaking - Living in the US - Ages 14 - 18 Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Short videos
Intervention videos will each be of 90-second duration and feature four underage professionals (ages 16) acting as simulated patients. All videos will focus on an empowered presenter with depression sharing their personal story regarding depression and describe how social supports from family, friends, and community, as well as professional help assisted them in overcoming symptoms of their illness. The actors will include a transgender male, a cis-gender male, a transgender female, and a cis-gender female.

Locations

Country Name City State
United States Yale Child Center New Haven Connecticut
United States Yale Child Study Center New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Billard TJ. Attitudes Toward Transgender Men and Women: Development and Validation of a New Measure. Front Psychol. 2018 Apr 3;9:387. doi: 10.3389/fpsyg.2018.00387. eCollection 2018. — View Citation

Griffiths KM, Christensen H, Jorm AF, Evans K, Groves C. Effect of web-based depression literacy and cognitive-behavioural therapy interventions on stigmatising attitudes to depression: randomised controlled trial. Br J Psychiatry. 2004 Oct;185:342-9. — View Citation

Norton AT, Herek GM. Heterosexuals' attitudes toward transgender people: findings from a national probability sample of US Adults. Sex Roles. 2013;68(11-12):738-753. doi:10.1007/s11199-011-0110-6

Wilson CJ, Deane FP, Marshall KL, Dalley A. Adolescents' suicidal thinking and reluctance to consult general medical practitioners. J Youth Adolesc. 2010 Apr;39(4):343-56. doi: 10.1007/s10964-009-9436-6. Epub 2009 Jul 15. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Attitudes toward Transgender Men and Women (ATTMW) scale Attitudes toward Transgender Men and Women (ATTMW; Billard, 2018) is a scale to measure transphobic attitudes. It is a 24-item scale consisting of two similar but non-identical 12-item subscales, one for transgender males (ATTM), and one for women (ATTW). In this study, the study team will assign only one of the two subscales, according to the condition that subjects as randomly assigned to: those viewing the transgender adolescent male will be assigned to the ATTM; those to the female, to the ATTW. The results of both subscales are compatible with each other and can be merged into a single ATMW score. Each of the items is a statement on which participants are asked to rate their agreement on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
The first 9 items are the same for the ATTM and AATW. Items 10-12 are unique for each of the two scales. These
Before / after viewing videos (within 10 minutes)
Secondary Change in transgender attitudes: feelings thermometer This study will utilize a scale called feelings thermometer, modeled after Norton and Herek, 2013:
"Using a scale from zero to 100, please tell us your personal feelings toward each of the following groups of friends, teachers, or colleagues. As you do this task, think of an imaginary thermometer. The warmer or more favorable you feel toward the group, the higher the number you should give it. The colder or less favorable you feel, the lower the number. If you feel neither warm nor cold toward the group, rate it 50." To familiarize respondents with the response format, they will be first presented with thermometers for "Men in general" and "Women in general," with each respondent rating her or his own sex first. Next, they rate different gender groups (transgender males, transgender females). Higher ratings (maximum 100) indicate warmer, more favorable feelings toward the target whereas lower ratings (minimum 0) indicate colder, more negative feelings.
Before / after viewing videos (within 10 minutes)
Secondary Change in Depression-related stigma (Depression Stigma Scale [DSS]; Personal component only): TOTAL SCORE The DSS (Christensen, Jorm, Evans, & Groves, 2004) is a self-report instrument composed of two 9-item subscales. The first subscale measures the participants' own/ personal attitudes, and the second measures participants' beliefs about the attitudes of others ('Depression is sign of weakness' vs. 'Most people believe that depression is a sign of weakness'). The Personal subscale (DSS-Personal) will be used in this study. The DSS has a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). The total score comprises the sum of its item scores, and a higher score indicates more stigma (worse outcome). The DSS-Personal subscale has shown adequate psychometric properties: 0.71 test-retest reliability, 0.76 internal consistency (Griffiths et al., 2004). In our earlier study (Amsalem and Martin, 2021), Cronbach's a was .83. Before / after viewing videos (within 10 minutes)
Secondary Change in Help-seeking (General Help-Seeking Questionnaire [GHSQ]; Emotional and Suicide components): MEAN SCORE The General Help-Seeking Questionnaire (GHSQ) (Wilson, Deane, Marshall, & Dalley, 2008) was developed to measure help-seeking intentions from different sources (friend, parent, mental health professional, and others) and is divided into personal-emotional problems and suicidal thoughts (Ibrahim et al., 2019). The instrument consists of 10 items for each part, each rated on a 0 (extremely unlikely) to 7 (extremely likely)Likert scale. Higher scores on this scale indicate more help seeking (better outcome).
General stem:
If you were having a personal or emotional problem, how likely is it that you would seek help from the following people?
Before / after viewing videos (within 10 minutes)
Secondary Change in DSS Item 1 DDS Item #1: People with depression could snap out of it if they wanted.
Scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5)
Before / after viewing videos (within 10 minutes)
Secondary Change in DSS Item 2 DDS Item #2: Depression is a sign of personal weakness
Scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). A higher score indicates more stigma (worse outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in DSS Item 3 DDS Item #3: Depression is not a real medical illness
Scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). A higher score indicates more stigma (worse outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in DSS Item 4 DDS Item #4: People with depression are dangerous
Scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). A higher score indicates more stigma (worse outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in DSS Item 5 DDS Item #5: It is best to avoid people with depression, so you don't become depressed yourself
Scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). A higher score indicates more stigma (worse outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in DSS Item 6 DDS Item #6: People with depression are unpredictable
Scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). A higher score indicates more stigma (worse outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in DSS Item 7 DDS Item #7: If I had depression, I would not tell anyone
Scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). A higher score indicates more stigma (worse outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in DSS Item 8 DDS Item #8 : I would not employ someone if I knew they had been depressed
Scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). A higher score indicates more stigma (worse outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in DSS Item 9 DDS Item #9: I would not vote for a politician if I knew they had been depressed
Scored on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). A higher score indicates more stigma (worse outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Emotional Item 1 If you were having a personal or emotional problem, how likely is it that you would seek help from the following people?
Intimate partner (e.g., girlfriend, boyfriend)
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Emotional Item 2 If you were having a personal or emotional problem, how likely is it that you would seek help from the following people?
Friend (not related to you)
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Emotional Item 3 If you were having a personal or emotional problem, how likely is it that you would seek help from the following people?
Parent
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Emotional Item 4 If you were having a personal or emotional problem, how likely is it that you would seek help from the following people?
Other relative/family member
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Emotional Item 5 If you were having a personal or emotional problem, how likely is it that you would seek help from the following people?
Mental health professional (e.g., psychologist, social worker, counselor)
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Emotional Item 6 If you were having a personal or emotional problem, how likely is it that you would seek help from the following people?
Phone helpline (e.g., lifeline)
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Emotional Item 7 If you were having a personal or emotional problem, how likely is it that you would seek help from the following people?
Doctor/GP
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Emotional Item 8 If you were having a personal or emotional problem, how likely is it that you would seek help from the following people?
Minister or religious leader (e.g., Priest, Rabbi, Chaplain)
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Emotional Item 9 If you were having a personal or emotional problem, how likely is it that you would seek help from the following people?
I would not seek help from anyone
**REVERSE SCORED ITEM** Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). LOWER scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Emotional Item 10 If you were having a personal or emotional problem, how likely is it that you would seek help from the following people?
Emotional Item # 10: I would seek help from another not listed above
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Suicide Item 1 If you were having suicidal thoughts, how likely is it that you would seek help from the following people?
Intimate partner (e.g., girlfriend, boyfriend)
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Suicide Item 2 If you were having suicidal thoughts, how likely is it that you would seek help from the following people?
Friend (not related to you)
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Suicide Item 3 If you were having suicidal thoughts, how likely is it that you would seek help from the following people?
Parent
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Suicide Item 4 Other relative/family member
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Suicide Item 5 If you were having suicidal thoughts, how likely is it that you would seek help from the following people?
Mental health professional (e.g., psychologist, social worker, counselor)
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Suicide Item 6 If you were having suicidal thoughts, how likely is it that you would seek help from the following people?
Phone helpline (e.g., lifeline)
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Suicide Item 7 If you were having suicidal thoughts, how likely is it that you would seek help from the following people?
Doctor/GP
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Suicide Item 8 If you were having suicidal thoughts, how likely is it that you would seek help from the following people?
Minister or religious leader (e.g., Priest, Rabbi, Chaplain)
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Suicide Item 9 If you were having suicidal thoughts, how likely is it that you would seek help from the following people?
GHSQ Item# 9: I would not seek help from anyone
**REVERSE SCORED ITEM** Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). LOWER scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in GHSQ Suicide Item 10 If you were having suicidal thoughts, how likely is it that you would seek help from the following people?
GHSQ Item# 10:I would seek help from another not listed above
Measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). Higher scores on this item indicate more help seeking (better outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in ATTMW Item 1 ATTMW Item#1: Transgender men/women will never really be men/women
Score on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in ATTMW Item 2 ATTMW Item#2:Transgender men/women are not really men/women
Score on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in ATTMW Item 3 ATTMW Item#3:Transgender men/women are only able to look like men/women, but not be men/women
Score on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in ATTMW Item 4 ATTMW Item#4:Transgender men/women are unable to accept who they really are
Score on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in ATTMW Item 5 ATTMW Item#5:Transgender men/women are trying to be someone they're not
Score on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in ATTMW Item 6 Transgender adolescent men/women are denying their DNA
Score on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in ATTMW Item 7 ATTMW Item #8:Transgender men/women cannot just "identify" as men/women
Score on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in **ATTM** Item 11 ATTM Item #11: Transgender men are misguided
Score on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in ATTMW Item 8 ATTMW Item #10:Transgender men/women are unnatural
Score on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in ATTMW Item 9 ATTMW Item #11:Transgender men/women don't really understand what it means to be a man/woman
Score on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in **ATTM** Item 11 ATTMW Item #11:Transgender men are emotionally unstable
Score on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in **ATTW** Item 11 Transgender women are defying their nature. Before / after viewing videos (within 10 minutes)
Secondary Change in **ATTM** Item 10 Transgender men seem absolutely normal to me (R)
(R) = REVERSE-SCORED
Scored on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in **ATTW** Item 10 Transgender women only think they are females
Scored on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
Secondary Change in **ATTW** Item 12 There is something unique about being a woman that transgender adolescent females can never experience
Scored on a 7-point Likert-type scale: from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater anti-transgender prejudice, while lower scores indicate less prejudice.
Before / after viewing videos (within 10 minutes)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A