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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04890990
Other study ID # 2000028980
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2021
Est. completion date August 7, 2021

Study information

Verified date August 2021
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purposes of this study are to: 1. test among adolescent the utility of brief video-based interventions to reduce stigma-related attitudes and increase help-seeking intentions toward depression; 2. examine the role of race (Black vs other) as an independent factor in the primary outcome.


Description:

Intervention videos will each be of ~120-second duration and feature an underage female professional (age 16) acting as a simulated patient. All three videos will focus on her as an empowered presenter with depression sharing her personal story regarding depression and describe how social supports from family, friends, and community, as well as professional help assisted her in overcoming symptoms of the illness. Assessments will occur at baseline and post-intervention, and will include: 1. Demographics (baseline only); 2. Primary outcome: Depression-related stigma(Depression Stigma Scale [DSS]) summary score. 3. Secondary outcomes: a. DSS individual items; b. Help-seeking (General Help-Seeking Questionnaire [GHSQ]) summary score and individual items; and bc Racial attitudes: feelings thermometers. The investigators intend to randomly assign ~1,000 individuals aged 14-18 as follows: Subjects oversampled for Black participants (50% Black; 50% other); Randomized, in equal proportions, and stratified by race, to view one of three ~120-second videos of a girl with: 1. No depression control (Black; BC); 2. Depression (Black, following same script as in our earlier study (Amsalem and Martin, 2021), DB); and 3. Depression adjusted (Black, with script adjusted based on input from focus group of Black girls and women; DBa).


Recruitment information / eligibility

Status Completed
Enrollment 1291
Est. completion date August 7, 2021
Est. primary completion date August 7, 2021
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 two underage professionals (ages 16) acting as a simulated patient. All videos will focus on an empowered presenter with depression sharing her personal story regarding depression and describe how social supports from family, friends, and community, as well as professional help assisted her in overcoming symptoms of the illness. The actors will include a Black girl and a white girl.

Locations

Country Name City State
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 (3)

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 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'). We will use the Personal subscale (DSS-Personal) 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, measured with a 7-point Likert scale ranging from 1 (extremely unlikely) to 7 (extremely likely). One question is stated as 'I would not seek help from anyone' and is reverse-scored. Higher scores on this scale indicate more help seeking (better outcome). The GHSQ has shown good psychometric properties: Cronbach's alpha = .70 and test-retest of .86 for personal-emotional problems, and Cronbach's alpha = .83 and test-retest of .88 for suicidal thoughts. Before / after viewing videos (within 10 minutes)
Secondary Change in Racial attitudes: feelings thermometer We will use a 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 racially different groups (white women, white men, Black women, Black men) with the order of presentation randomized. 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 DSS 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). A higher score indicates more stigma (worse outcome).
Before / after viewing videos (within 10 minutes)
Secondary Change in DSS 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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)
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