PMID- 37883133
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240210
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 12
DP  - 2023 Oct 26
TI  - The Mood, Mother and Child Study: Protocol for a Prospective Longitudinal Study 
      and Randomized Controlled Trial.
PG  - e51132
LID - 10.2196/51132 [doi]
LID - e51132
AB  - BACKGROUND: Perinatal depression affects >400,000 mother-child dyads in the 
      United States every year and is associated with numerous adverse maternal and 
      child developmental outcomes. Previous research implicates the dysregulation of 
      oxytocin and the 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 
      study will examine the 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 the study hypotheses. METHODS: This is a prospective longitudinal study 
      with an embedded randomized controlled trial that examines (1) correlations among 
      postpartum depression and anxiety symptoms, maternal and child oxytocin and HPA 
      axis functioning, and child developmental outcomes and (2) the causal 
      relationship between exogenous oxytocin 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 a prospective longitudinal research design with an embedded 
      randomized controlled trial will allow the Mood, Mother and Child study to apply 
      a developmental lens to the study of maternal depression and anxiety symptoms 
      from birth to 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 oxytocin and HPA 
      axis functioning among mothers with 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 are to provide insights into the psychobiological effects of oxytocin 
      in women and inform future clinical trials to treat perinatal mood disorders. 
      TRIAL REGISTRATION: ClinicalTrials.gov NCT03593473; 
      https://classic.clinicaltrials.gov/ct2/show/NCT03593473. INTERNATIONAL REGISTERED 
      REPORT IDENTIFIER (IRRID): DERR1-10.2196/51132.
CI  - (c)W Roger Mills-Koonce, Karen Grewen, Nisha Gottredson O'Shea, Brenda Pearson, 
      Chelsea Grace Strange, Samantha E Meltzer-Brody, Jerry Dolph Guintivano, Alison M 
      Stuebe. Originally published in JMIR Research Protocols 
      (https://www.researchprotocols.org), 26.10.2023.
FAU - Mills-Koonce, W Roger
AU  - Mills-Koonce WR
AUID- ORCID: 0000-0002-9923-1831
AD  - School of Education, The University of North Carolina at Chapel Hill, Chapel 
      Hill, NC, United States.
FAU - Grewen, Karen
AU  - Grewen K
AUID- ORCID: 0000-0003-2588-6568
AD  - School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, 
      NC, United States.
FAU - O'Shea, Nisha Gottredson
AU  - O'Shea NG
AUID- ORCID: 0000-0002-4765-7179
AD  - Research Triangle Institute, Inc., Research Triangle Park, NC, United States.
FAU - Pearson, Brenda
AU  - Pearson B
AUID- ORCID: 0000-0002-4662-1748
AD  - School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, 
      NC, United States.
FAU - Strange, Chelsea Grace
AU  - Strange CG
AUID- ORCID: 0000-0002-8520-1746
AD  - School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, 
      NC, United States.
FAU - Meltzer-Brody, Samantha E
AU  - Meltzer-Brody SE
AUID- ORCID: 0000-0002-8509-408X
AD  - School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, 
      NC, United States.
FAU - Guintivano, Jerry Dolph
AU  - Guintivano JD
AUID- ORCID: 0000-0003-3541-1101
AD  - School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, 
      NC, United States.
FAU - Stuebe, Alison M
AU  - Stuebe AM
AUID- ORCID: 0000-0002-1228-4587
AD  - School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, 
      NC, United States.
LA  - eng
SI  - ClinicalTrials.gov/NCT03593473
GR  - R01 HD073220/HD/NICHD NIH HHS/United States
GR  - R01 HD093901/HD/NICHD NIH HHS/United States
PT  - Journal Article
DEP - 20231026
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC10636628
OTO - NOTNLM
OT  - HPA axis
OT  - executive functioning
OT  - hypothalamic-pituitary-adrenal axis
OT  - maternal depression
OT  - oxytocin
OT  - parenting
OT  - socioemotional development
COIS- Conflicts of Interest: None declared.
EDAT- 2023/10/26 12:43
MHDA- 2023/10/26 12:44
PMCR- 2023/10/26
CRDT- 2023/10/26 11:53
PHST- 2023/07/22 00:00 [received]
PHST- 2023/07/25 00:00 [accepted]
PHST- 2023/10/26 12:44 [medline]
PHST- 2023/10/26 12:43 [pubmed]
PHST- 2023/10/26 11:53 [entrez]
PHST- 2023/10/26 00:00 [pmc-release]
AID - v12i1e51132 [pii]
AID - 10.2196/51132 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2023 Oct 26;12:e51132. doi: 10.2196/51132.