INFANT HEALTH- Promoting Mental Health and Healthy Weight in Infancy Through Sensitive Parenting

NCT04601779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2026-05-05

No results posted yet for this study

Summary

Mental health problems and overweight often co-occur, they have their origin in early childhood and new research evidence suggest a key role of cognitive, emotional and behavioral regulation in the early developmental trajectories and points to the benefits of intervention in infancy that builds on strategies of sensitive parenting.

The research group behind this project has developed the PUF program (PUF: In Danish: 'Psykisk Udvikling og Funktion') to target infants' mental health and development within the settings of community health nurses. Still, measures are lacking that address the infants most vulnerable regarding the development and progression of mental health problems and overweight.

In this project, we develop and test a new intensified intervention to address major cognitive and regulatory vulnerabilities identified at child age 9-10 months and adapted to the settings of community health nurses. The intervention is created as an add-on to the PUF-program, using an evidence-based method to promote sensitive parenting, the Video-based Intervention to Promote Positive Parenting (VIPP). The new intervention VIPP-PUF comprises six therapeutic sessions delivered by the community health nurse during home visits over a three months period. The intervention builds on teaching the health nurses to promote parents' sensitivity to meet the infants' cognitive and regulatory vulnerabilities, and it takes in account the needs of psycho-socially disadvantaged families.

The Infant Health project is conducted in sixteen municipalities across Denmark. We use the Intervention Mapping approach as the study frame and integrate the best practice of community health nurses. The efficacy of the VIPP-PUF intervention is examined in a randomized controlled step-wedge design, in which approximately 1.000 children are followed up to the age of 24 months.

The VIPP-PUF intervention is hypothesized to reduce mental health problems at ages 24 months among infants with high levels of cognitive and regulatory problems at age 9-10 months, (primary outcome). Also, it is hypothesized that among children with high levels of cognitive and regulatory vulnerabilities at age 9-10 months, adding the VIPP-PUF intervention to treatment as usual at age 9-10 months, will reduce infants' cognitive and regulatory problems; promote healthy weight development; reduce parents' experiences of stress; promote sensitive parenting and promote parents' feeling of competence and relatedness.

Conditions

  • Infant Mental Health
  • Parenting
  • Parent-Child Relations

Interventions

BEHAVIORAL

VIPP-PUF

The VIPP-PUF Intervention is developed as an add-on to the existing PUF-program to address infants with major cognitive and regulatory vulnerabilities identified at age 9-10 months and adapted to the settings of community health nurses. The intervention (VIPP-PUF) will be created from an evidence-based method, the Video-based Intervention to Promote Positive Parenting (VIPP), to comprise six therapeutic sessions delivered by the community health nurse during home visits over a three months period. The VIPP -PUF builds on teaching the health nurses to promote parents' sensitivity to meet infants' cognitive and regulatory vulnerabilities, while taking in account the particular needs of families of psycho-social disadvantage.

Sponsors & Collaborators

  • Danish Council for Independent Research

    collaborator OTHER
  • The Novo Nordic Foundation

    collaborator OTHER
  • University of Glasgow

    collaborator OTHER
  • ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

    collaborator OTHER
  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Anne Mette Skovgaard, MD DM SCI · Professor

  • Morten Hulvej Rod, PhD · Head of the National Institut of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
9 Months
Max Age
11 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2025-05-05
Completion
2025-05-27

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04601779 on ClinicalTrials.gov