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

NCT ID: NCT05423093

Last Updated: 2025-09-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2025-04-28

Brief Summary

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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

Detailed Description

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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)

Conditions

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Postpartum Depression Postpartum Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention delivery

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

Group Type EXPERIMENTAL

Single-Session Virtual Group Psychoeducational Session about Postpartum Depression

Intervention Type BEHAVIORAL

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.

Interventions

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Single-Session Virtual Group Psychoeducational Session about Postpartum Depression

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 Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rheanna Platt, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23830020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28851459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34152503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27085546 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38963477 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.rrfss.ca/questionnaires

Rapid Risk Factor Surveillance System

Other Identifiers

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1K23MH118431-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00170216

Identifier Type: -

Identifier Source: org_study_id

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