Plain English Summary
Background and study aims
Many factors influence whether or not someone seeks help for depression. The purpose of this study is to understand how African American students’ willingness to seek help for depression can change.
Who can participate?
People who identify as Black or African American, are between the ages of 18-25 and have never been diagnosed with or received treatment for mental illness are welcome to participate.
What does the study involve?
If you agree to participate in this study, you will be asked to complete the anonymous pre-test and post-test surveys and actively participate in a course about depression. The course will provide you with information about depression and how you feel about people who may be affected. You will be asked to work in groups to discuss various issues, view videos about depression and share your opinions with others during a discussion. This course will take about 2 hours and 30 minutes. You will also have an opportunity to voluntarily participate in an anonymous 3-month follow-up survey that will take approximately 15 minutes to complete. This study will include approximately 114 participants.
What are the possible benefits and risks of participating?
There are no foreseeable risks to participating in this study. All responses are anonymous, and we will not ask for identifiable information. Therefore, the survey cannot be linked to you. You will receive no direct benefit from participating in this study; however, your participation in this study will add to the general knowledge of depression help-seeking among African American college students.
Where is the study run from?
This study is run from the University of Texas at Austin.
When is the study starting and how long is it expected to run for?
The study is expected to run from November 2016 to April 2017.
Who is funding the study?
This study is funded by the Hogg Foundation for Mental Health.
Who is the main contact?
Benita Bamgbade
benitabam@gmail.com
Trial website
Contact information
Type
Public
Primary contact
Dr Benita Bamgbade
ORCID ID
http://orcid.org/0000-0003-1645-5838
Contact details
140 The Fenway
Room R218X
360 Huntington Avenue
Boston
02115
United States of America
6173737973
b.bamgbade@northeastern.edu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
HU3732007
Study information
Scientific title
An intervention to improve willingness to seek help for depression among African American young adults: a non-randomised study
Acronym
Study hypothesis
1. Willingness to seek help will significantly increase from pre to immediate post-test.
1.1. Attitude toward seeking help will significantly increase (more favourable attitude) from pre to immediate post-test.
1.2. Perceived behavioural control will significantly increase from pre to immediate post-test.
1.3. Mental illness (MI) stigma will significantly decrease from pre to immediate post-test.
2. MI Stigma and Cultural variables (medical mistrust, self-reliance and religiosity) will significantly increase the predictive power of the regression model compared to a model that utilizes only the TPB constructs (attitude, subjective norm, perceived behavioural control and covariates [gender identity, depression knowledge and MI personal experience]) to predict willingness to seek help.
Ethics approval
Approved 11/11/2016, the University of Texas Institutional Review Board (The University of Texas at Austin, Office of Research Support and Compliance, Peter T. Flawn Academic Center, Suite 426, 2304 Whitis Ave, Austin, TX 78712; 512-471-8871), ref: 2016-10-0111.
Study design
Prospective one group intervention, non-randomised design with three month follow up
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participation information sheet
Condition
Depression
Intervention
The intervention consisted of three sections. Section 1 was led by the primary researcher, who is also a licensed pharmacist. This section consisted of the introduction, an opening activity, an active learning activity (fact or fiction), a depression overview, and another active learning activity (peanut butter in the jar)
Section 2, led by a licensed AA psychologist (from the university health centre and also the liaison to Black & African-American students in the counselling and mental health centre), focused on stigma and the unique cultural variables that impact AA help-seeking (identified in the Information Gathering stage). This section also featured a video clip of a young AA celebrity athlete discussing his personal experience with MI and his journey to recovery, a group discussion and a psychotherapy question and answer session.
The last section, section 3, was dedicated to a young AA college student consumer educator who shared his lived experience with schizophrenia and depression. This presentation was followed by a question and answer session where students had the opportunity to interact with the consumer educator. The study intervention was designed as a 2 hour and 30 min course in efforts to maintain participant engagement and avoid participant fatigue.
The follow-up survey consisted of a survey (identical to the post-test survey) with additional questions assessing actual help-seeking behaviour.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Willingness to seek help for depression is measured using a self-administered anonymous survey at baseline, immediately following the intervention (post-test) and at the 3-month follow up. All survey items were created by the researchers of this study using previous focus groups and the Theory of Planned Behaviour as a guiding framework:
2. Actual behaviour is measured at the 3-month follow-up.
Secondary outcome measures
The following variables are collected using self-administered anonymous surveys at baseline, immediately following the intervention (post-test) and at the 3-month follow up. All survey items were created by the researchers of this study using previous focus groups and the Theory of Planned Behaviour as a guiding framework:
1. Attitude
2. Perceived behavioural control
3. Stigma
Overall trial start date
16/04/2016
Overall trial end date
30/09/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Identify as Black or African American
2. 18-25 years old
3. Never been diagnosed with and/or received treatment for a mental health condition
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
114
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
20/08/2016
Recruitment end date
16/11/2016
Locations
Countries of recruitment
United States of America
Trial participating centre
University of Texas at Austin
110 Inner Campus Drive
Austin, TX 78705
Austin
78705
United States of America
Sponsor information
Organisation
The University of Texas at Austin
Sponsor details
110 Inner Campus Drive
Austin
TX 78705
Austin
78705
United States of America
512-471-3434
orsc@uts.cc.utexas.edu
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Hogg Foundation for Mental Health
Alternative name(s)
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results from this study will be submitted to peer-review journals via 2 manuscripts in 2019.
IPD sharing statement: the datasets generated during and/or analysed during the current study are not expected to be made available due to requirements designated by the University of Texas at Austin Institutional Review Board.
Intention to publish date
31/12/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2020 protocol in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7055854/ (added 25/09/2020