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Clinical Trials/NCT05423093
NCT05423093
Completed
N/A

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

Johns Hopkins University1 site in 1 country26 target enrollmentJune 9, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postpartum Depression
Sponsor
Johns Hopkins University
Enrollment
26
Locations
1
Primary Endpoint
Satisfaction as Assessed by the Intervention Satisfaction Survey
Status
Completed
Last Updated
8 months ago

Overview

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

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)

Registry
clinicaltrials.gov
Start Date
June 9, 2022
End Date
April 28, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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

  • 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)
  • Self-reported Mental Health Service Utilization Within the Past 6 Months(6 months post-intervention)
  • Psychosocial Resource Utilization as Assessed by Questionnaire(6-months post-intervention)

Study Sites (1)

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