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Testing Mediators and Moderators of a Fotonovela for Depression to Promote Help-seeking Behavior

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ClinicalTrials.gov Identifier: NCT04319458
Recruitment Status : Active, not recruiting
First Posted : March 24, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Louise Dixon De Silva, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE September 6, 2019
First Posted Date  ICMJE March 24, 2020
Last Update Posted Date March 25, 2020
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
Help-Seeking Behavior [ Time Frame: 3 months ]
The measure of help-seeking behavior is a checklist of behaviors that has been modified from the Service Assessment for Children and Adolescents. The measure assesses different sources of treatment, including psychiatrist, psychologist, social worker, spiritual advisors, ER visits, and traditional healers. Participants are asked if in the past 3 months, they have sought services from any of these professionals. Each item is binary (i.e., Yes or No). The total score will be calculated by summing the number of "yes" answers (i.e., the number of services used).
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
Help-Seeking Behavior [ Time Frame: 3 months ]
Our measure of help-seeking behavior is a checklist of behaviors that has been modified from the Service Assessment for Children and Adolescents. The measure assesses different sources of treatment, including psychiatrist, psychologist, social worker, spiritual advisors, ER visits, and traditional healers. Participants are asked if in the past 3 months, they have sought services from any of these professionals. Each item is binary (i.e., Yes or No). The total score will be calculated by summing the number of "yes" answers (i.e., the number of services used).
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testing Mediators and Moderators of a Fotonovela for Depression to Promote Help-seeking Behavior
Official Title  ICMJE Entertainment Education for Depression in Latinx Adults: Testing Mediators and Moderators of a Culture-Centric Narrative Intervention to Promote Help-Seeking Behavior
Brief Summary Although rates of depression are similar in Latinx populations compared to non-Latinx whites (NLW), there are significant disparities in service utilization. Mental health literacy - one's knowledge and attitudes about mental health and treatment-seeking - is a significant predictor of help-seeking behavior and likely contributes to mental health disparities among Latinx. Understanding ways to improve mental health literacy in Latinx populations is important to reducing these disparities. Health literacy interventions that are engaging, dramatic, and culturally-relevant, such as fotonovelas (graphic novels designed to change health-related knowledge and attitudes), show promise in changing mental health literacy in Latinx populations. However, little is known about how these interventions work and for whom they are most effective. Furthermore, although there is some evidence that fotonovelas can change mental health attitudes and intent to seek treatment, their impact on help-seeking behavior is less understood. The purpose of this study is to examine 1) if narrative and cultural elements of a fotonovela for Latinx with depression (i.e., transportation, identification, and social proliferation) are important mediators in changing mental health attitudes and help-seeking behaviors and 2) if factors such as rurality, acculturation, depression severity and logistic barriers to treatment moderate these relationships.
Detailed Description

Latinx adults with depression are a particularly vulnerable population; although Latinx exhibit similar rates of depression to other racial/ethnic groups, they are less likely to seek treatment, are more likely to drop out of treatment, and thus experience greater chronicity of depression. This health disparity is likely due to a complex network of factors, but mental health literacy is one important contributing factor. Latinx are more likely to exhibit lower mental health literacy (including misconceptions, stigma, knowledge of treatment, etc.), which contributes to lower rates of treatment-seeking. Understanding how to engage Latinx in depression treatment by overcoming health literacy barriers is important in reducing health disparities.

Entertainment-education interventions are those that use popular media to engage consumers and deliver health messages. These interventions hypothesized to be useful in targeting populations with health disparities in encouraging changes in health-related behavior through dramatic and culturally-relevant narrative elements. However, no study has tested these theorized mechanisms in helping to explain changes in health literacy and subsequent health behavior.

This study will test the impact of a graphic novel about depression specifically for Latinx adults with depressive symptoms on theorized mediators, including transportation (feeling emotionally engaged in the narrative), identification (cultural relevance of characters, their language, and their appearance), and social proliferation (sharing of health information and mutual reinforcement of health behaviors). Furthermore, this study will test if these mediators help explain changes in mental health literacy and subsequent health behavior. Lastly, this study will test moderators of changes in mental health literacy and behavior to determine for whom the fotonovela has the largest impact.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Mental Health Literacy
Intervention  ICMJE
  • Behavioral: Fotonovela
    Secret Feelings/Sentimientos Secretos
  • Behavioral: Control
    NIH Brochure: Depression: What You Need to Know
Study Arms  ICMJE
  • Experimental: Fotonovela
    Fotonovela mental health literacy intervention: Secret Feelings/Sentimientos Secretos
    Intervention: Behavioral: Fotonovela
  • Active Comparator: Control
    Control mental health literacy intervention: NIH publication - Depression: What You Need to Know
    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 23, 2020)
182
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2020)
216
Estimated Study Completion Date  ICMJE August 30, 2020
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older
  • fluent in English or Spanish
  • mild, moderate, or severe levels of depression
  • identify as Latinx or Hispanic

Exclusion Criteria:

  • receipt of psychotherapy or pharmacotherapy for mental health problems in the last 6 months
  • unable to read in English or Spanish
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04319458
Other Study ID Numbers  ICMJE 19-000112
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Louise Dixon De Silva, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Los Angeles
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP