Clinical trial NCT05423093: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Postpartum Anxiety
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-06-21
Enrollment: 19
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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


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

Primary outcomes:
measure: Satisfaction as assessed by the Intervention Satisfaction Survey
timeFrame: Completed by parent participants within 2 weeks of attending video group session
measure: Acceptability of intervention Measure
timeFrame: Completed by parent participants within 2 weeks of attending video group session
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 1 week
measure: Acceptability of the Intervention as assessed by the Intervention Appropriateness Measure
timeFrame: 3 months
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 6 months
measure: Feasibility of Intervention Measure
timeFrame: 1 week
measure: Feasibility of Intervention Measure
timeFrame: 3 months
measure: Feasibility of Intervention Measure
timeFrame: 6 months
Secondary outcomes:
measure: Change in mental health care stigma as assessed by the Stigma Concerns about Mental Health Care (SCMHC) scale
timeFrame: Completed by parent participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session
measure: Change in Depression Stigma as assessed by the Adapted Personal Stigma Scale (PSS)
timeFrame: Completed by participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session
measure: Change in Postpartum Depression Knowledge as assessed by Adapted Postpartum Depression Knowledge Measure
timeFrame: Completed by participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session
measure: Change in Intention to disclose if developed postpartum depression symptoms as assessed by questionnaire
timeFrame: Completed by parent participants at baseline (pre-session); within 2 weeks post-session; and 6 months post-session
measure: Intention to seek primary care as assessed by questionnaire
timeFrame: completed within 2 weeks of attending video group session.
measure: Mental health utilization as assessed by the Mental Health Service Utilization
timeFrame: Baseline, 6 months post-intervention (completed by parent)
measure: Psychosocial Resource Utilization as assessed by questionnaire
timeFrame: 6-months post-intervention, completed by participant
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
References:
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.
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.
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.
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.