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

Not Applicable

Recruiting

• Conditions: Postpartum Anxiety; Postpartum Depression
• Interventions: Behavioral: Single-Session Virtual Group Psychoeducational Session about Postpartum Depression

• Registration Number: NCT05423093
• Lead Sponsor: Johns Hopkins University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-31
• Study Start: 2022-06-09
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Primary Completion: 2023-11-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-05
• Study Completion: 2024-09-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention delivery	Single-Session Virtual Group Psychoeducational Session about Postpartum Depression	Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.

Primary Outcome Measures

Name	Time	Method
Satisfaction as assessed by the Intervention Satisfaction Survey	Completed by parent participants within 2 weeks of attending video group session	8 items, 5-point likert scale from 1 (strongly disagree) to 5 (strongly agree), higher scores indicative of higher satisfaction. No established cutoff.
Acceptability of intervention Measure	Completed by parent participants within 2 weeks of attending video group session	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. Cut-off scores for interpretation are not yet available; however, higher scores indicate greater acceptability
Acceptability of the Intervention as assessed by the Intervention Appropriateness Measure	3 months	4-question pragmatic measure designed to assess the perceived fit, relevance, or compatibility of an intervention/innovation for a given practice setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue or problem. Questions assess the degree to which the respondent agrees with the following statements: (1) "The intervention seems fitting", (2) "The intervention seems suitable"; (3) The intervention seems applicable; (4) The intervention seems like a good match. Possible responses include: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Cut-off scores for interpretation are not yet available, however, higher scores indicate greater perceived appropriateness
Feasibility of Intervention Measure	6 months	4-question pragmatic measure designed to assess construct of intervention feasibility. 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Cut-off scores for interpretation are not yet available, however, higher scores indicate greater perceived feasibility
Intervention Appropriateness Measure (IAM)	6 months	4-question pragmatic measure designed to assess the perceived fit, relevance, or compatibility of an intervention/innovation for a given practice setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue or problem. Questions assess the degree to which the respondent agrees with the following statements: (1) "The intervention seems fitting", (2) "The intervention seems suitable"; (3) The intervention seems applicable; (4) The intervention seems like a good match. Possible responses include: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Cut-off scores for interpretation are not yet available, however, higher scores indicate greater perceived appropriateness

Secondary Outcome Measures

Name	Time	Method
Change in Postpartum Depression Knowledge as assessed by Adapted Postpartum Depression Knowledge Measure	Completed by participants at baseline (pre-session); within 2 weeks post-session; and 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.
Change in Intention to disclose if developed postpartum depression symptoms as assessed by questionnaire	Completed by parent participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session	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. Responses are no (0) and Yes (1)
Change in mental health care stigma as assessed by the Stigma Concerns about Mental Health Care (SCMHC) scale	Completed by parent participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session	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
Change in Depression Stigma as assessed by the Adapted Personal Stigma Scale (PSS)	Completed by participants at baseline (pre-session); within 2 weeks post-session; and 6 months 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). Total scores range from 0 to 28, higher scores indicating higher levels of personal depression stigma
Intention to seek primary care as assessed by questionnaire	completed within 2 weeks of attending video group session.	Developed for this study, single likert scale question, asked of participants who did not have an identified primary care doctor at baseline: 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
Mental health utilization as assessed by the Mental Health Service Utilization	Baseline, 6 months post-intervention (completed by parent)	Single item, adapted from National Latino and Asian American Study
Psychosocial Resource Utilization as assessed by questionnaire	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?

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States