The Infant Health Study - Promoting mental health and healthy weight through sensitive parenting to infants with cognitive, emotional, and regulatory vulnerabilities: protocol for a stepped-wedge cluster-randomized trial and a process evaluation within municipality settings

Anne Mette Skovgaard*, Marian Bakermans-Kranenburg, Maiken Pontoppidan, Tine Tjørnhøj-Thomsen, Katrine Rich Madsen, Ida Voss, Stine Kjær Wehner, Trine Pagh Pedersen, Lotte Finseth, Rodney S. Taylor, Janne Schurmann Tolstrup, Janni Ammitzbøll

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Background: Child mental health problems are a major public health concern associated with poor mental and physical health later in development. The study evaluates a new community-based intervention to promote sensitive parenting and reduce enduring mental health problems and unhealthy weight among vulnerable infants aged 9-24 months. Methods: We use a step-wedge cluster randomized controlled trial design conducted within a home visiting program offered by community health nurses to infant families in Denmark. Sixteen municipalities are randomly allocated to implement the intervention starting at three successive time points from May 1, 2022 to January 1, 2023. A total of 900-1000 families will be included. A standardized program, Psykisk Udvikling og Funktion (PUF), is used to identify infants with major problems of eating, sleep, emotional or behavioral regulation or developmental problems. The intervention builds on the Video-Feedback Intervention to Promote Positive Parenting (VIPP) program, adapted to the PUF-context and named the VIPP-PUF. Children will be followed up at ages 18 and 24 months. Primary outcome measure is the Strengths and Difficulties Questionnaire (SDQ) at child age 24 months. The other outcome measures include body mass index z-scores, the Ages and Stages Questionnaire Social-Emotional (ASQ:SE2); the Child Behavior Checklist (CBCL 1½ -5); Eating behavior Questionnaires; the Being a Mother-questionnaire (BaM13); the Parental Stress Scale (PSS); and the WHO-5 well-being index (WHO-5). Data on child and family factors are obtained from National registries and the Child Health Database. Quantitative measures are applied to examine the effectiveness of the VIPP-PUF intervention and the implementation process. Qualitative measures include interviews with CHNs, parents and municipality stakeholders to explore factors that may influence the adherence and effectiveness of the intervention. Discussion: The study examines a service-setting based intervention building on the promotion of sensitive parenting to vulnerable infants. We use a mixed methods approach to evaluate the intervention, taking into account the influences of COVID-19 pandemic running since March 2020. Overall, the study has potential to add to the knowledge on the possibilities of prevention within the municipality child health care to reduce the risk of mental health problems and unhealthy weight in early childhood. Trial registration: www.ClinicalTrials.gov; IDNCT04601779; Protocol ID 95-110-21307. Registered 25 June 2021.

OriginalsprogEngelsk
Artikelnummer194
TidsskriftBMC Public Health
Vol/bind22
Udgave nummer1
ISSN1471-2458
DOI
StatusUdgivet - jan. 2022

Bibliografisk note

Funding Information:
AMS is the chief investigator and led the design of the study and the application for funding. She led the preparation of this manuscript for submission. JA, JST, TTT, MP and MBK have contributed to the design of the study and the grant applications. JST and RST have designed the stepped wedge trial, and advised on the sample size, randomization plan and developed the analytic plan for the effectiveness of the intervention. JA is the practical trial manager and co-PI. JA, LF and MBK led on the adaption of the intervention manual. MP provided methodological guidance and expertise throughout the design of the study and the development of the protocol. JA and IV established the research database. KRM, TTT and SKW are the qualitative researchers who designed and will lead the qualitative aspects of the process evaluation. TPP contributes to the study regarding the Child Health database. All authors have contributed to the writing and revisions of the manuscript and approved the final manuscript.

Funding Information:
We thank the leading and practicing health nurses in the municipalities Albertslund, Aller?d, Br?ndby, Drag?r, Egedal, Fures?, Fredensborg, Gladsaxe, Glostrup, Herlev, Hiller?d, H?je-T?strup, Kalundborg, K?ge, Roskilde, Rudersdal, Vejle; The Child Research group at the National Institute of Public Health, University of Southern Denmark; and Msc PhD Camilla Smith Morgen and MD PhD Else Marie Olsen.

Publisher Copyright:
© 2022, The Author(s).

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