NCT05423093

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

June 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2025

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 7, 2025

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

May 31, 2022

Results QC Date

April 25, 2025

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Satisfaction as Assessed by the Intervention Satisfaction Survey

    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.

    Within 2 weeks of attending video group session

  • Acceptability of Intervention Measure

    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)

    Within 2 weeks of attending video group session

Secondary Outcomes (7)

  • Pre-Post Intervention Change in Mental Health Care Stigma as Assessed by the Stigma Concerns About Mental Health Care (SCMHC) Scale

    Baseline (pre-session); within 2 weeks post-session

  • Change in Depression Stigma as Assessed by the Adapted Personal Stigma Scale (PSS)

    Baseline (pre-session); within 2 weeks post-session

  • Postpartum Depression Knowledge as Assessed by Adapted Postpartum Depression Knowledge Measure

    Completed by participants at baseline (pre-session); within 2 weeks post-session; 6 months post session

  • Intention to Disclose if Developed Postpartum Depression Symptoms as Assessed by Questionnaire

    Baseline (pre-session); within 2 weeks post-session; and 6 months post-session

  • Intention to Seek Primary Care as Assessed by Survey Question

    Baseline, Within 2 weeks of attending video group session, 6 months post intervention

  • +2 more secondary outcomes

Study Arms (1)

Intervention delivery

EXPERIMENTAL

Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.

Behavioral: Single-Session Virtual Group Psychoeducational Session about Postpartum Depression

Interventions

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.

Intervention delivery

Eligibility Criteria

Age16 Years - 99 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<16 years old, preferred healthcare language not Spanish, not planning to attend participating practice, clinic staff determines contraindication to participation in group discussion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (5)

  • 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.

    PMID: 23830020BACKGROUND
  • 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.

    PMID: 28851459BACKGROUND
  • 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.

    PMID: 34152503BACKGROUND
  • 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.

    PMID: 27085546BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Results Point of Contact

Title
Rheanna Platt
Organization
Johns Hopkins University

Study Officials

  • Rheanna Platt, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 21, 2022

Study Start

June 9, 2022

Primary Completion

November 30, 2024

Study Completion

April 28, 2025

Last Updated

September 3, 2025

Results First Posted

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations