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

doi:10.1186/s12889-022-12551-z

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

^*Corresponding author for this work

Research output: Contribution to Journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Article number	194
Pages (from-to)	1-19
Number of pages	19
Journal	BMC Public Health
Volume	22
DOIs	https://doi.org/10.1186/s12889-022-12551-z
Publication status	Published - 28 Jan 2022

Bibliographical 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).

Funding

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. 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.

Funders	Funder number
Syddansk Universitet
Novo Nordisk Fonden	20SH0063466
Novo Nordisk Fonden
Danmarks Frie Forskningsfond	9130-00071B
Danmarks Frie Forskningsfond

Keywords

Community health services
Early intervention
Infants
Mental health problems
Mixed-methods
Process-evaluation
Sensitive parenting
Step-wedge randomized controlled trial
Unhealthy weight

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Skovgaard, A. M., Bakermans-Kranenburg, M., Pontoppidan, M., Tjørnhøj-Thomsen, T., Madsen, K. R., Voss, I., Wehner, S. K., Pedersen, T. P., Finseth, L., Taylor, R. S., Tolstrup, J. S., & Ammitzbøll, J. (2022). 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. BMC Public Health, 22, 1-19. Article 194. https://doi.org/10.1186/s12889-022-12551-z

Skovgaard, Anne Mette ; Bakermans-Kranenburg, Marian ; Pontoppidan, Maiken et al. / 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. In: BMC Public Health. 2022 ; Vol. 22. pp. 1-19.

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title = "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",

abstract = "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.",

keywords = "Community health services, Early intervention, Infants, Mental health problems, Mixed-methods, Process-evaluation, Sensitive parenting, Step-wedge randomized controlled trial, Unhealthy weight",

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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: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = jan,

day = "28",

doi = "10.1186/s12889-022-12551-z",

language = "English",

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journal = "BMC Public Health",

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Skovgaard, AM, Bakermans-Kranenburg, M, Pontoppidan, M, Tjørnhøj-Thomsen, T, Madsen, KR, Voss, I, Wehner, SK, Pedersen, TP, Finseth, L, Taylor, RS, Tolstrup, JS & Ammitzbøll, J 2022, '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', BMC Public Health, vol. 22, 194, pp. 1-19. https://doi.org/10.1186/s12889-022-12551-z

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. / Skovgaard, Anne Mette; Bakermans-Kranenburg, Marian; Pontoppidan, Maiken et al.
In: BMC Public Health, Vol. 22, 194, 28.01.2022, p. 1-19.

Research output: Contribution to Journal › Article › Academic › peer-review

TY - JOUR

T1 - 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

AU - Skovgaard, Anne Mette

AU - Bakermans-Kranenburg, Marian

AU - Pontoppidan, Maiken

AU - Tjørnhøj-Thomsen, Tine

AU - Madsen, Katrine Rich

AU - Voss, Ida

AU - Wehner, Stine Kjær

AU - Pedersen, Trine Pagh

AU - Finseth, Lotte

AU - Taylor, Rodney S.

AU - Tolstrup, Janne Schurmann

AU - Ammitzbøll, Janni

N1 - 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).

PY - 2022/1/28

Y1 - 2022/1/28

N2 - 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.

AB - 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.

KW - Community health services

KW - Early intervention

KW - Infants

KW - Mental health problems

KW - Mixed-methods

KW - Process-evaluation

KW - Sensitive parenting

KW - Step-wedge randomized controlled trial

KW - Unhealthy weight

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DO - 10.1186/s12889-022-12551-z

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SN - 1471-2458

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JO - BMC Public Health

JF - BMC Public Health

M1 - 194

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Skovgaard AM, Bakermans-Kranenburg M, Pontoppidan M, Tjørnhøj-Thomsen T, Madsen KR, Voss I et al. 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. BMC Public Health. 2022 Jan 28;22:1-19. 194. doi: 10.1186/s12889-022-12551-z

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

Abstract

Bibliographical note

Funding

Keywords

Access to Document

Persistent URL (handle)

Other files and links

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Cite this