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

Postpartum Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05423093
• Other study ID #: IRB00170216
• Secondary ID: 1K23MH118431-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: September 9, 2024

Study information

• Verified date: December 2023
• Source: Johns Hopkins University
• Contact: Rheanna Platt
• Phone: 410-550-8753
• Email: rplatt1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: September 9, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Postpartum Anxiety
• Postpartum Depression

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction as assessed by the Intervention Satisfaction Survey	8 items, 5-point likert scale from 1 (strongly disagree) to 5 (strongly agree), higher scores indicative of higher satisfaction. No established cutoff.	Completed by parent participants within 2 weeks of attending video group session
Primary	Acceptability of intervention Measure	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	Completed by parent participants within 2 weeks of attending video group session
Primary	Intervention Appropriateness Measure (IAM)	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	1 week
Primary	Acceptability of the Intervention as assessed by the Intervention Appropriateness Measure	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	3 months
Primary	Intervention Appropriateness Measure (IAM)	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	6 months
Primary	Feasibility of Intervention Measure	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	1 week
Primary	Feasibility of Intervention Measure	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	3 months
Primary	Feasibility of Intervention Measure	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	6 months
Secondary	Change in mental health care stigma as assessed by the Stigma Concerns about Mental Health Care (SCMHC) scale	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	Completed by parent participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session
Secondary	Change in Depression Stigma as assessed by the Adapted Personal Stigma Scale (PSS)	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	Completed by participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session
Secondary	Change in Postpartum Depression Knowledge as assessed by Adapted Postpartum Depression Knowledge Measure	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.	Completed by participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session
Secondary	Change in Intention to disclose if developed postpartum depression symptoms as assessed by questionnaire	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)	Completed by parent participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session
Secondary	Intention to seek primary care as assessed by questionnaire	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	completed within 2 weeks of attending video group session.
Secondary	Mental health utilization as assessed by the Mental Health Service Utilization	Single item, adapted from National Latino and Asian American Study	Baseline, 6 months post-intervention (completed by parent)
Secondary	Psychosocial Resource Utilization as assessed by questionnaire	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?	6-months post-intervention, completed by participant

External Links

•   National Latino and Asian American Study Documents
•   Rapid Risk Factor Surveillance System