Developing and Testing a Preventive Primary Care Parenting Intervention to Strengthen Parent-Infant Co-Regulation in Families Experiencing Early Regulatory Difficulties

Summary

The goal of this randomized controlled trial is to evaluate the effectiveness of a structured parenting support program for families with young infants experiencing early regulatory difficulties. Participants are families with infants approximately 3 months of age who score above a predefined threshold on a screening questionnaire assessing early regulatory problems.

The main questions this study aims to answer are:

* Does participation in the parenting support program reduce parental stress and improve parental self-efficacy from baseline to post-intervention?
* Does the intervention reduce infant regulatory problems (e.g., excessive crying, feeding difficulties, and sleep problems) at 6-month follow-up (i.e., when the child is approximately 12 months old)?

Researchers will compare families receiving the structured parenting support program to families receiving usual care to evaluate the effects of the intervention.

Participants will complete questionnaires when the infant is approximately 3-4 months old (baseline), around 6 months of age (post-intervention), and follow-up assessments will be conducted when the child is approximately 9 and 12 months old.

If assigned to the intervention group, participants will attend one individual session and five group sessions led by trained psycho-educators and receive access to psycho-educational content through a mobile application.

Conditions

• Infant Regulatory Problems
• Regulatory Problems in Infancy
• Parental Stress
• Parental Self-efficacy

Interventions

BEHAVIORAL

Structured early parenting support program, called "Eat, sleep, cry - repeat"

The program includes one individual session with a trained psycho-educator, five group sessions (two in person, three online), and access to a digital support tool via a mobile application. Sessions provide psycho-education, discussion, reflection, and peer support. The modules in the app address early regulatory difficulties such as excessive crying, feeding, or sleep problems, as well as other themes such as social support and the partner relationship. In the group sessions, the psycho-educators will refer to and expand on the app materials, allowing for deeper discussion and personalization of the content in line with the needs and questions of participating families.

Sponsors & Collaborators

• KU Leuven

  collaborator OTHER

• Opgroeien

  collaborator UNKNOWN

• Universiteit Antwerpen

  lead OTHER

Principal Investigators

• Edwin Wouters, Prof. Dr. · Universiteit Antwerpen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-06

Primary Completion

2027-01-31

Completion

2027-07-31

Countries

• Belgium

Study Locations