Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care
Primary Purpose
Postpartum Depression, Postpartum Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression
Sponsored by
About this trial
This is an interventional health services research trial for Postpartum Depression
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
Sites / Locations
- Johns Hopkins Bayview Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention delivery
Arm Description
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Outcomes
Primary Outcome Measures
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.
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
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
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
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
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
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
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
Secondary Outcome Measures
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
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
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.
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)
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
Mental health utilization as assessed by the Mental Health Service Utilization
Single item, adapted from National Latino and Asian American Study
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?
Full Information
NCT ID
NCT05423093
First Posted
May 31, 2022
Last Updated
April 13, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05423093
Brief Title
Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care
Official Title
Pediatric Group Well Child Visits for Detection of Maternal Depression in Latinas
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
September 9, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Postpartum Anxiety
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention delivery
Arm Type
Experimental
Arm Description
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Intervention Type
Behavioral
Intervention Name(s)
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression
Intervention Description
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 Outcome Measure Information:
Title
Satisfaction as assessed by the Intervention Satisfaction Survey
Description
8 items, 5-point likert scale from 1 (strongly disagree) to 5 (strongly agree), higher scores indicative of higher satisfaction. No established cutoff.
Time Frame
Completed by parent participants within 2 weeks of attending video group session
Title
Acceptability of intervention Measure
Description
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
Time Frame
Completed by parent participants within 2 weeks of attending video group session
Title
Intervention Appropriateness Measure (IAM)
Description
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
Time Frame
1 week
Title
Acceptability of the Intervention as assessed by the Intervention Appropriateness Measure
Description
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
Time Frame
3 months
Title
Intervention Appropriateness Measure (IAM)
Description
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
Time Frame
6 months
Title
Feasibility of Intervention Measure
Description
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
Time Frame
1 week
Title
Feasibility of Intervention Measure
Description
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
Time Frame
3 months
Title
Feasibility of Intervention Measure
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in mental health care stigma as assessed by the Stigma Concerns about Mental Health Care (SCMHC) scale
Description
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
Time Frame
Completed by parent participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session
Title
Change in Depression Stigma as assessed by the Adapted Personal Stigma Scale (PSS)
Description
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
Time Frame
Completed by participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session
Title
Change in Postpartum Depression Knowledge as assessed by Adapted Postpartum Depression Knowledge Measure
Description
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.
Time Frame
Completed by participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session
Title
Change in Intention to disclose if developed postpartum depression symptoms as assessed by questionnaire
Description
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)
Time Frame
Completed by parent participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session
Title
Intention to seek primary care as assessed by questionnaire
Description
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
Time Frame
completed within 2 weeks of attending video group session.
Title
Mental health utilization as assessed by the Mental Health Service Utilization
Description
Single item, adapted from National Latino and Asian American Study
Time Frame
Baseline, 6 months post-intervention (completed by parent)
Title
Psychosocial Resource Utilization as assessed by questionnaire
Description
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?
Time Frame
6-months post-intervention, completed by participant
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rheanna Platt
Phone
410-550-8753
Email
rplatt1@jhmi.edu
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rheanna Platt, MD
Phone
410-550-8753
Email
rplatt1@jhmi.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23830020
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.
Results Reference
background
PubMed Identifier
28851459
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.
Results Reference
background
PubMed Identifier
34152503
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.
Results Reference
background
PubMed Identifier
27085546
Citation
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.
Results Reference
background
Links:
URL
https://www.rrfss.ca/questionnaires
Description
Rapid Risk Factor Surveillance System
URL
https://www.massgeneral.org/mongan-institute/centers/dru/research/past/nlaas-docs
Description
National Latino and Asian American Study Documents
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Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care
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