- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05423093
Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care
Pediatric Group Well Child Visits for Detection of Maternal Depression in Latinas
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current study is designed as an open/single-arm pilot of the intervention (no comparison arm for this initial/preliminary study, which is also being offered as a clinic service).
Participants include Spanish-speaking parents of infants (6 months or younger) attending a pediatric practice.
Parents are recruited via flyers posted at the clinic as well as via referral from pediatric providers and staff (who can obtain permission from family for research staff to discuss the study with the family at the visit and/or to contact the family at a later time).
After screening, oral consent is obtained over the phone or zoom, and baseline measures are collected over the phone or zoom, prior to attendance at the intervention session.
Intervention Sessions will be offered at regular intervals, on at least a monthly basis, via Zoom. The sessions (desiged to last 45-60 minutes), which will be observed by research staff with permission of participants, are co-facilitated by a bilingual clinic social worker and bilingual community health worker.
Sessions consist of the following content:
1) Introduction and discussion of the purpose of the session/group; (2) Overview of services available at the clinic; (3) information about postpartum depression, including a five minute video testimonial followed by facilitated discussion about (a) prevalence and signs of postpartum depression, discussion of postpartum depression screening procedures and rationale for screening at the pediatric office, discussion of self-care and social support, and discussion of community resources (a list of resources are also mailed to the participants); (4) Discussion about insurance and health care for the infant and mother, including free/sliding scale clinics offering primary care for adults and rationale for engaging in one's own primary care in addition to pediatric health care for the infant.
After the session (within 2 weeks post-session) the research team collects post-session measures (see outcome measures) and conducts semi-structured interviews with participants.
6 months after the session, the research team will administer questionnaires over the phone assessing feedback about the intervention, physical and mental health services utilization, and post-intervention assessments (see outcome measures)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins Bayview Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parent participants will be eligible if the preferred healthcare language is Spanish, if they are the mother of an infant (<2 months of age) attending participating pediatric practice, and if she is not felt to have a contraindication to participation (e.g., condition in the parent that would preclude the ability to reasonably participate in a virtual group session) by clinic staff
- Clinic staff participants - facilitators of virtual groups
Exclusion Criteria:
- <16 years old, preferred healthcare language not Spanish, not planning to attend participating practice, clinic staff determines contraindication to participation in group discussion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention delivery
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
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Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction as Assessed by the Intervention Satisfaction Survey
Time Frame: Within 2 weeks of attending video group session
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Completed by parent participants.
5-point likert scale from 1 (strongly disagree) to 5 (strongly agree), higher scores indicative of higher satisfaction.
No established cutoff.
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Within 2 weeks of attending video group session
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Acceptability of Intervention Measure
Time Frame: Within 2 weeks of attending video group session
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Completed by parent participants.
4-question pragmatic measure designed to assess construct of intervention acceptability as perceived by participant. 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree.
Higher scores indicate greater acceptability.
Score for each participant calculated as mean score for each item (range 1-5)
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Within 2 weeks of attending video group session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-Post Intervention Change in Mental Health Care Stigma as Assessed by the Stigma Concerns About Mental Health Care (SCMHC) Scale
Time Frame: Baseline (pre-session); within 2 weeks post-session
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Completed by parent participants.
The SCMHC is a 3-item measure assessing stigma-related barriers to the utilization of depression treatment (internalized stigma, fear of stigmatization, and stigma from family in seeking mental health care).
Responses are coded as (0) disagree, (1) agree, and (7) don't know/refuse.
Respondents receive one point for each response of "agree," which indicates agreement with the stigma-related barrier.
The total scores range from 0 to 3 with higher scores indicating an increased internalization of stigma to mental health care
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Baseline (pre-session); within 2 weeks post-session
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Change in Depression Stigma as Assessed by the Adapted Personal Stigma Scale (PSS)
Time Frame: Baseline (pre-session); within 2 weeks post-session
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7 items, assess personal attitudes towards people with depression.
Items answered on 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
Calculated as average item score, higher scores indicate higher levels of depression stigma.
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Baseline (pre-session); within 2 weeks post-session
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Postpartum Depression Knowledge as Assessed by Adapted Postpartum Depression Knowledge Measure
Time Frame: Completed by participants at baseline (pre-session); within 2 weeks post-session; 6 months post session
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Measure of participant knowledge about postpartum depression knowledge- adapted and translated from the Ontario Rapid Risk Factor Surveillance Survey.
Questions include whether the participant has heard of the concept of postpartum depression, asks participants to name symptoms of postpartum depression, and asks participants how common they would estimate the condition to be.
There is no standard scale/scoring.
Percent of participants answering affirmatively to the question "Have you heard of postpartum depression?" is reported.
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Completed by participants at baseline (pre-session); within 2 weeks post-session; 6 months post session
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Intention to Disclose if Developed Postpartum Depression Symptoms as Assessed by Questionnaire
Time Frame: Baseline (pre-session); within 2 weeks post-session; and 6 months post-session
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Completed by parent participants.
Single-question item: If I felt down, depressed, hopeless, or having little interest or pleasure in doing things I would try to contact someone at this clinic.
Response options were No or Yes.
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Baseline (pre-session); within 2 weeks post-session; and 6 months post-session
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Intention to Seek Primary Care as Assessed by Survey Question
Time Frame: Baseline, Within 2 weeks of attending video group session, 6 months post intervention
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Developed for this study, single likert scale question asked of participants who did not have an identified primary care doctor: As a result of the video group session, I plan to identify a doctor that I can see regularly for my own check-ups.
Adapted from National Latino and Asian American Study.
Scale range from 1-5, 1= strongly agree; 2=agree; 3=neutral/no opinion, 4=disagree, 5=strongly disagree
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Baseline, Within 2 weeks of attending video group session, 6 months post intervention
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Self-reported Mental Health Service Utilization Within the Past 6 Months
Time Frame: 6 months post-intervention
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Single item, adapted from National Latino and Asian American Study; question: "within the past 6 months, have you had a therapy session with a psychologist or therapist or another professional that lasted 30 minutes or longer"?.
Response options included "Yes", "No", "Unsure", and "Prefer Not to Answer".
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6 months post-intervention
|
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Psychosocial Resource Utilization as Assessed by Questionnaire
Time Frame: 6-months post-intervention
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Completed by participant.
Question developed for this project and translated/certified, assessing use of clinic ancillary services discussed in the intervention: In the past 2 months, have you used any of the resources that were discussed in the video session or on the clinic website?
Responses could include "Yes", "No", or "Unsure"
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6-months post-intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rheanna Platt, MD, Johns Hopkins University
Publications and helpful links
General Publications
- Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Fothergill KE, Gadomski A, Solomon BS, Olson AL, Gaffney CA, Dosreis S, Wissow LS. Assessing the impact of a web-based comprehensive somatic and mental health screening tool in pediatric primary care. Acad Pediatr. 2013 Jul-Aug;13(4):340-7. doi: 10.1016/j.acap.2013.04.005.
- Eghaneyan BH, Killian MO, Sanchez K, Cabassa LJ. Psychometric Properties of Three Measures of Stigma Among Hispanics with Depression. J Immigr Minor Health. 2021 Oct;23(5):946-955. doi: 10.1007/s10903-021-01234-3. Epub 2021 Jun 19.
- Caplan S. A Pilot Study of a Novel Method of Measuring Stigma about Depression Developed for Latinos in the Faith-Based Setting. Community Ment Health J. 2016 Aug;52(6):701-9. doi: 10.1007/s10597-016-0005-7. Epub 2016 Apr 16.
- Platt R, Richman R, Martin C, Martin KJ, Mendelson T. Feasibility and Acceptability of a Video Group Psychoeducational Intervention with Latina Immigrant Mothers to Enhance Infant Primary care. J Immigr Minor Health. 2024 Oct;26(5):945-952. doi: 10.1007/s10903-024-01612-7. Epub 2024 Jul 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00170216
- 1K23MH118431-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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