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

NCT04601779 | Completed

• 1 other identifier: 95-110-21307
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Infant mental health; Regulatory problems; Developmental psychopathology; Video-feedback to Promote Positive Parenting, VIPP; Overeating in infancy; Infancy overweight

Outcome Measures

Primary Outcomes (2)

• Child mental health

  The Strengths and Difficulties Questionnaire (SDQ) answered by parents is used at ages 24 months in order to use this very short (25-items) and feasible measure both at age 24 months and at the planned follow-up at older ages. SDQ is highly predictive of persistent child mental health problems and suitable for the prospective investigation of mental health from ages 24 months and onwards. SDQ has been validated for use in children down to the age of 2 years, and used in epidemiological research worldwide, also in Danish populations, with Danish norms being available.

  child age 24 months

• Social and emotional development

  The Ages and Stages Questionnaire, Social-Emotional 2 (ASQ: SE2) (version for children aged 1 to 60 months) is used to measure the child's self regulation, compliance, communication and adaptive functioning. It comprises 19 to 33 items rated by parents and includes a box parents in which parents may check if the behavior is a concern for them. The ASQ:SE2 is well-validated and the most commonly used measure of young children's social and emotional development, internationally as well as in Denmark.

  Child age 24 months

Secondary Outcomes (9)

• Weight-for-length z-scores

  child age 24 months

• Parenting

  Child age 24 months

• Parental Stress

  Child age 24 months

• Family impairment

  Child age 24 months

• Sensitive parenting

  Child age 24 months

Other Outcomes (9)

• Social and emotional development

  Child at age 18 months

• Parenting

  Child at age 18 months

• Parental Stress

  Child at age 18 months

Study Arms (3)

Cluster I

OTHER

Cluster I is randomized to start the VIPP-PUF intervention phase May 1, 2022

Behavioral: VIPP-PUF

Cluster II

OTHER

Cluster II is randomized to start the VIPP-PUF intervention phase November 1, 2022

Behavioral: VIPP-PUF

Cluster III

OTHER

Cluster IiI is randomized to start the VIPP-PUF intervention phase March 1, 2023

Behavioral: VIPP-PUF

Interventions

VIPP-PUF BEHAVIORAL

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.

Cluster I; Cluster II; Cluster III

Eligibility Criteria

• Age: 9 Months - 11 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Three or more PUF problems at the PUF

You may not qualify if:

• Severe mental or physical illness or handicap.
• Not Danish or English speaking parents

Sponsors & Collaborators

• University of Southern Denmark: lead
• Danish Council for Independent Research: collaborator
• The Novo Nordic Foundation: collaborator
• University of Glasgow: collaborator
• ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida: collaborator

Study Sites (1)

National Institute of Public Health

Copenhagen, Denmark

Location

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Related Links

• World Health Organization. Childhood overweight and obesity 2016
• SDQ Danish home page

Study Officials

• Anne Mette Skovgaard, MD DM SCI

  Professor

  PRINCIPAL INVESTIGATOR

• Morten Hulvej Rod, PhD

  Head of the National Institut of Public Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 26, 2020
• Study Start: August 16, 2021
• Primary Completion: May 5, 2025
• Study Completion: May 27, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)