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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Jul 22, 2023
Date Accepted: Jul 25, 2023

The final, peer-reviewed published version of this preprint can be found here:

The Mood, Mother and Child Study: Protocol for a Prospective Longitudinal Study and Randomized Controlled Trial

Mills-Koonce WR, Grewen K, O’Shea NG, Pearson B, Strange CG, Meltzer-Brody SE, Guintivano JD, Stuebe A

The Mood, Mother and Child Study: Protocol for a Prospective Longitudinal Study and Randomized Controlled Trial

JMIR Res Protoc 2023;12:e51132

DOI: 10.2196/51132

PMID: 37883133

PMCID: 10636628

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Mood, Mother and Child Study: Prospective Longitudinal Study and Randomized Control Trial

  • W. Roger Mills-Koonce; 
  • Karen Grewen; 
  • Nisha Gottredson O’Shea; 
  • Brenda Pearson; 
  • Chelsea Grace Strange; 
  • Samantha E. Meltzer-Brody; 
  • Jerry Dolph Guintivano; 
  • Alison Stuebe

ABSTRACT

Background:

Perinatal depression affects more than 400,000 mother-child dyads in the US every year and is associated with numerous adverse maternal and child developmental outcomes. Prior research implicates the dysregulation of oxytocin (OT) and hypothalamic-pituitary-adrenal (HPA) axis functioning in mothers and children as potential mechanisms mediating or moderating the transmission of risk associated with maternal depression.

Objective:

The Mood, Mother and Child (MMC) Study will examine psychobiological sources of risk and resilience within mother-child dyads affected by maternal depression. This manuscript describes (1) the study rationale and aims; (2) the research design and procedures and how they were altered in response to the Covid-19 pandemic, and (3) the data analysis plan to test study hypotheses.

Methods:

This is a prospective longitudinal study with an embedded randomized control trial that examines (1) correlations between postpartum depression and anxiety symptoms (PDAS), maternal and child OT and HPA axis functioning, and child developmental outcomes; and (2) the causal relationship between causal relationships between exogenous OT and HPA reactivity. This study is funded by the National Institute of Child Health and Human Development with Institutional Review Board approval.

Results:

Recruitment and data collection have commenced, and the expected results will be available in 2024. Analyses are presented for testing the proposed hypotheses.

Conclusions:

The unique combination of prospective longitudinal research design with an embedded RCT will allow the MMC Study to apply a developmental lens to the study of maternal depression and anxiety symptoms from birth through middle childhood and the psychobiological mechanisms promoting risk and resiliency for both mother and child outcomes. This will be the first study that simultaneously evaluates (1) the role of oxytocin using multiple methodologies, (2) the causal relationships between exogenous OT and HPA axis functioning among mothers at differing levels of depression and anxiety symptoms, and (3) the multiple mediating and moderating roles of parenting behaviors and maternal and child psychobiological characteristics. The goals of these aims is to provide insights into the psychobiological effects of OT in women and to inform future clinical trials to treat perinatal mood disorders Clinical Trial: This studyis registered with Clinical Trials.gov (NCT03593473).


 Citation

Please cite as:

Mills-Koonce WR, Grewen K, O’Shea NG, Pearson B, Strange CG, Meltzer-Brody SE, Guintivano JD, Stuebe A

The Mood, Mother and Child Study: Protocol for a Prospective Longitudinal Study and Randomized Controlled Trial

JMIR Res Protoc 2023;12:e51132

DOI: 10.2196/51132

PMID: 37883133

PMCID: 10636628

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