# Administrative Supplement: “Mamma Mia”: A multisite randomized controlled trial of an internet-based program for preventing and reducing perinatal depressive symptoms

> **NIH NIH R01** · VIRGINIA COMMONWEALTH UNIVERSITY · 2021 · $251,680

## Abstract

Project Summary - for Administrative Supplement to the Mamma Mia Study (1R01HD100395-01; PI:
Kinser)
This request for an administrative supplement is in response to NOT-OD-21-071. Summary of Parent Study:
The parent study (1R01HD100395-01), or the “Mamma Mia Study”, is a large-scale multi-site randomized
controlled trial (RCT) evaluating the effects of an internet and mobile-based approach (Mamma Mia) for
preventing and intervening with perinatal depressive and related symptoms in n=1950 diverse women across
the country. In particular, the purpose of this longitudinal multisite three-group RCT is to compare the effects,
and explore mediators and moderators of these effects, of three groups: Mamma Mia (self-guided internet/
mobile-based program); Mamma Mia Plus (self-guided internet/mobile-based program PLUS guided clinical
support); and, usual care. The parent study has successfully met study timelines; we have enrolled n=523
participants in Year 1 and anticipate enrolling n=600 participants during the period of the administrative
supplement. Summary of Administrative Supplement: The supplement will explore several questions to
address three goals defined in NOT-OD-21-071, addressing maternal mortality and morbidity in the context of
the COVID-19 pandemic: (1) How does SARS-CoV-2 infection affect mental health and functioning of the
Mamma Mia study population? (2) Does the perceived impact of the COVID-19 pandemic increase risk for
depressive symptoms in pregnant and postpartum women, and does this perceived impact serve as a
moderator of the effects of the intervention over time? (3) What is the impact of structural racism and
discrimination on maternal health outcomes of the study population in the context of COVID-19? Specifically,
how do sociodemographic factors, marginalization and intersectionality (e.g., race/ethnicity, education status,
type of employment), contextualized stress (using measures designed specifically for underrepresented
minority women), and perceived discrimination relate to risk of depressive symptoms in pregnant and
postpartum women, and do these moderate the effects of the intervention over time? How do these factors
relate to birth outcomes, pregnancy complications, and/or perinatal health (e.g., preterm birth, elevated
maternal blood pressure, perinatal mood and anxiety) in the study population? (4) How do resilience and risk
factors in the context of the COVID-19 pandemic (e.g., perceived coping, economic stress, food/housing
insecurity, death of partner, domestic violence) affect perinatal health outcomes in this study population? To
answer these questions, we will add to the research team an expert in SRD and perinatal mental health; an
expert in trauma and resilience; and two Consultants/ Community Partners to enhance community-
engagement and address key issues of recruitment, retention, and structural bias in research with
underserved, minority populations. We will use common data elements (e.g., DR2, PhenX too...

## Key facts

- **NIH application ID:** 10382034
- **Project number:** 3R01HD100395-02S1
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** Patricia Anne Kinser
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $251,680
- **Award type:** 3
- **Project period:** 2021-09-01 → 2025-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10382034

## Citation

> US National Institutes of Health, RePORTER application 10382034, Administrative Supplement: “Mamma Mia”: A multisite randomized controlled trial of an internet-based program for preventing and reducing perinatal depressive symptoms (3R01HD100395-02S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10382034. Licensed CC0.

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