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.

Regulatory problems and developmental psychopathology within the first 2 years of living—a nested in cohort population-based study

“…Early identification of developmental vulnerability has to run in parallel with strategies to promote child development and reduce the risk of mental health problems and disorders (57), optimally integrating sensitive parenting and social learning as described, for example, in the Video-based Intervention to Promote sensitive Parenting (VIPP), which has shown promising results, also among regulatory disturbed infants (56,58,59).…”

Community health nurses' concerns about infant regulatory problems are predictive of mental disorders diagnosed at hospital: a prospective cohort study

“…Danish community healthcare includes the services from CHNs, who are trained to identify children who are not developing in an age-appropriate way and to communicate with parents about the developmental needs of the child (24). Still, research is needed to further explore CHNs' potentials regarding the prevention of mental health problems in early childhood (37), and specifically, how the existing CHN surveillance program can deliver the frame for intervention to infants with regulatory problems.…”

“…Unfortunately, our data do not allow for the exploration of character or the magnitude of intervention offered in municipality settings in the time span explored. Still, the potentials of identification infancy markers of psychopathology based on the CHN (20, 22, 23) has been further explored within municipality settings in Denmark, resulting in the development of standardized measures to identify and intervene toward early developmental psychopathology (5,24,28,37).…”