Eat, Sleep, Cry - Repeat: a parent coaching program to help with infant self-regulation
Official title: Developing and Testing a Preventive Primary Care Parenting Intervention to Strengthen Parent-Infant Co-Regulation in Families Experiencing Early Regulatory Difficulties
Run by Universiteit Antwerpen · NCT07541716 · Data updated 2026-11-12
A structured parenting program for families with 3‑month‑old infants showing early regulatory problems is tested to see if it lowers parental stress and boosts parental confidence, and whether infant regulatory problems improve by around 12 months.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Universiteit Antwerpen Academic / other |
| Locations | 1 site (Antwerp) |
| Status | Recruiting |
| Started | May 6, 2026 |
| Main results expected | January 2027 |
| Study ends | July 2027 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07541716 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are parents of a roughly 3-month-old infant who screens positive for regulatory problems and can participate in an online program.
✕Probably not a fit
Families with infants who do not meet the regulatory problem threshold or cannot engage digitally may see little to no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial tests a structured early parenting support program called Eat, sleep, cry - repeat for families with infants who show regulatory difficulties. Eligible families are enrolled when the baby is about 3 months old and have a caregiver who screens above a cutoff for regulatory problems. Participants are randomly assigned to receive the parenting program or usual care, with outcomes measured at post-intervention and at about 12 months to see if infant regulatory problems and parental well-being improve. The study uses digital tools to deliver sessions and gather data through caregiver questionnaires. The lead institution is Universiteit Antwerpen, with collaboration from KU Leuven and Opgroeien.
Why it matters
Potential benefit: If successful, parents may experience less stress and higher self-efficacy, and infants may show fewer regulatory problems such as crying, feeding difficulties, and sleep issues.
How similar studies have gone: Previous work in parenting interventions for infant regulatory problems has shown potential benefits, but this exact online structured program is being evaluated for its additive impact.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parent (or primary caregiver) of an infant aged approximately 3 months at enrollment. * Aged 18 years or older. * One parent has completed the brief screening questionnaire and scored above a predefined cutoff indicating elevated levels of infant regulatory problems and eligibility for the intervention. Exclusion Criteria: * Insufficient proficiency in Dutch to understand study materials or participate in intervention sessions * No access to the internet or a compatible device required to use the mobile application
Where it's running
-
University of Antwerp
Antwerp, Belgium Recruiting
Study contacts
- Principal investigator: Edwin Wouters, Prof. Dr. — Universiteit Antwerpen
- Study coordinator: Fien Plochaet
- Email: fien.plochaet@uantwerpen.be
- Phone: +3232652016
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Pediatric Outpatient Health Data Cohort in Switzerland
This study tests the PROS-CH data-collection system in pediatric primary care to see if routine tools can build a useful cohort of children under age 2 for common health issues.
-
Supporting parents to improve preschool children's attention and behaviour
This program will try a parent-focused therapy combining DBT skills and parenting strategies with mothers who have depression to see if it reduces attention and behaviour problems in their 3–7-year-old children.
-
Mindfulness intervention for mothers and infants
This study tests if a mindfulness program for mothers and their babies can help reduce postpartum depression and anxiety while strengthening their bond.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.