Skip to main content
OpenTrials
Completed

NCT Number: NCT05423093

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

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:

  • 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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-Session Virtual Group Psychoeducational Session about Postpartum Depression

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.

Primary outcomes

  1. Satisfaction as Assessed by the Intervention Satisfaction Survey

    Time frame: 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.

  2. Acceptability of Intervention Measure

    Time frame: 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)

Secondary outcomes

  1. 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

    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

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

    Time frame: 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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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

  6. Self-reported Mental Health Service Utilization Within the Past 6 Months

    Time frame: 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".

  7. Psychosocial Resource Utilization as Assessed by Questionnaire

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Pediatric Group Well Child Visits for Detection of Maternal Depression in Latinas

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 21, 2022
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.