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NCT05423093

Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care

Completed NA Results posted Last updated 3 September 2025
What this trial tests

NA trial testing Single-Session Virtual Group Psychoeducational Session about Postpartum Depression in Postpartum Depression in 26 participants. Completed in 28 April 2025.

Timeline
9 June 2022
Primary endpoint
30 November 2024
28 April 2025

Quick facts

Lead sponsorJohns Hopkins University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposehealth services research
Enrollment26
Start date9 June 2022
Primary completion30 November 2024
Estimated completion28 April 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

Adults 16 to 99, female only, with Postpartum Depression or Postpartum Anxiety. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Satisfaction as Assessed by the Intervention Satisfaction Survey Primary · Within 2 weeks of attending video group session

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.

GroupValue95% CI
Intervention Delivery4.06± 0.63
Acceptability of Intervention Measure Primary · Within 2 weeks of attending video group session

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)

GroupValue95% CI
Intervention Delivery4.174 – 5
Pre-Post Intervention Change in Mental Health Care Stigma as Assessed by the Stigma Concerns About Mental Health Care (SCMHC) Scale Secondary · Baseline (pre-session); within 2 weeks post-session

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

GroupValue95% CI
Intervention Delivery-0.49± 0.97
Change in Depression Stigma as Assessed by the Adapted Personal Stigma Scale (PSS) Secondary · Baseline (pre-session); within 2 weeks post-session

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.

GroupValue95% CI
Intervention Delivery-0.27± 0.31
Postpartum Depression Knowledge as Assessed by Adapted Postpartum Depression Knowledge Measure Secondary · Completed by participants at baseline (pre-session); within 2 weeks post-session; 6 months post session

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.

Yes - Baseline/Pre-session
GroupValue95% CI
Intervention Delivery14
No - Baseline/Pre-session
GroupValue95% CI
Intervention Delivery8
Yes - Within 2 weeks Post-session
GroupValue95% CI
Intervention Delivery15
No - Within 2 Weeks Post-session
GroupValue95% CI
Intervention Delivery1
Yes - 6 Months Post-session
GroupValue95% CI
Intervention Delivery11
No - 6 Months Post-session
GroupValue95% CI
Intervention Delivery3
Intention to Disclose if Developed Postpartum Depression Symptoms as Assessed by Questionnaire Secondary · Baseline (pre-session); within 2 weeks post-session; and 6 months post-session

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.

Pre-intervention
GroupValue95% CI
Intervention Delivery22
Intervention Delivery0
Post-Intervention
GroupValue95% CI
Intervention Delivery15
Intervention Delivery1
6-month post intervention
GroupValue95% CI
Intervention Delivery14
Intervention Delivery0
Intention to Seek Primary Care as Assessed by Survey Question Secondary · Baseline, Within 2 weeks of attending video group session, 6 months post intervention

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

Baseline
GroupValue95% CI
Intervention Delivery2.71± 1.03
Post-intervention (within 2 weeks post intervention)
GroupValue95% CI
Intervention Delivery1.83± 0.37
6-months post intervention
GroupValue95% CI
Intervention Delivery2.07± 0.35
Self-reported Mental Health Service Utilization Within the Past 6 Months Secondary · 6 months post-intervention

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".

GroupValue95% CI
Intervention Delivery2
Intervention Delivery12
Intervention Delivery0
Intervention Delivery0
Psychosocial Resource Utilization as Assessed by Questionnaire Secondary · 6-months post-intervention

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"

GroupValue95% CI
Intervention Delivery4
Intervention Delivery9
Intervention Delivery1

Sponsor's own description

The goal of the proposed research is to test the feasibility and acceptability of a virtual group session which is intended to be offered universally to Spanish-speaking parents of newborns/infants attending pediatric primary care. The virtual session is intended to (1) enhance patient/family education about postpartum depression (PPD) and (2) Provide an orientation to families regarding relevant clinic and community psychosocial support resources available. The investigators will conduct a single-arm, open pilot of the session, which will be co-delivered by existing clinic staff (including social work and community outreach staff). 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. The overall aim of the project is to Develop and pilot a virtual group augmentation of standard individual well-child care to improve (1) clinic screening procedures, discussion about and initial management of maternal depressive symptoms with immigrant Latinas and (2) patient symptom recognition, symptom disclosure, and subsequent treatment engagement

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Feasibility and Acceptability of a Video Group Psychoeducational Intervention with Latina Immigrant Mothers to Enhance Infant Primary care.
    Platt R, Richman R, Martin C, Martin KJ, et al · · 2024 · PMID 38963477 · DOI 10.1007/s10903-024-01612-7

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05423093.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing