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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parental Stress; Infant Regulatory Problems; Regulatory Problems in Infancy; Parental Self-efficacy
• Intervention / Treatment: Behavioral: Structured early parenting support program, called "Eat, sleep, cry - repeat"

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fien Plochaet; Phone Number: +3232652016; Email: fien.plochaet@uantwerpen.be
• Study Contact Backup: Name: Sara De Bruyn; Email: sara.debruyn@uantwerpen.be

Study Locations

• Belgium
  • Antwerp, Belgium, 2000
    • University of Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Participants assigned to this condition will receive the six-week intervention program. They complete questionnaires during the 12-month study period.	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.
No Intervention: Control arm; Participants assigned to this arm complete the same questionnaires during the 12-month study period but do not receive the intervention. Participants assigned to this arm complete the same questionnaires during the 12-month study period but do not receive the structured parenting intervention. Participants receive care as usual, consisting of standard preventive child health care provided by routine services (e.g., monitoring of growth, development, and vaccinations). Additional support may be provided if concerns arise, but no structured intervention targeting regulatory problems is systematically offered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in parental self-efficacy, as measured by the Karitane Parenting Confidence Scale (KPCS), from baseline to post-intervention	Parental self-efficacy as measured by the Karitane Parenting Confidence Scale. Scores range from 0 to 45, with higher scores indicating greater parental self-efficacy.	Post-intervention (infant age approximately 6 months)
Changes in parental stress, as measured by the Parental Stress Scale (PSS; parental stress factor), from baseline to post-intervention	Parental stress as measured by the Parental Stress Scale (PSS). Based on the Dutch validation, a 15-item version with a two-factor structure is used, of which only the parental stress factor (9 items) is included in this study. Scores range from 5 to 45, with higher scores indicating higher levels of parental stress.	Post-intervention (infant age approximately 6 months)
Infant regulatory problems at 6-month follow-up (infant age approximately 12 months)	Infant regulatory problems as measured by a study-specific parent-report questionnaire assessing difficulties in domains such as crying, sleeping, and feeding. Responses are rated on a 5-point Likert scale, with higher scores indicating more regulatory problems.	6 months follow-up (infant age approximately 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in parental stress over time, as measured by the Parental Stress Scale (PSS; parental stress factor)	Parental stress as measured by the parental stress factor of the PSS, consisting of 9 items. Scores range from 5 to 45, with higher scores indicating higher levels of parental stress. Changes are assessed across all time points, including intervention effects and their maintenance over time.	Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in parental self-efficacy, as measured by the Karitane Parenting Confidence Scale (KPCS)	Parental self-efficacy as measured by the KPCS. Scores range from 0 to 45, with higher scores indicating greater parenting confidence. Changes are assessed across all time points, including intervention effects and their maintenance over time.	Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in infant regulatory problems over time	Infant regulatory problems as measured by a study-specific parent-report questionnaire assessing difficulties in domains such as crying, sleeping, and feeding. Responses are rated on a 5-point Likert scale, with higher scores indicating more regulation problems. Changes are assessed across all time points, including intervention effects and their maintenance over time.	Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 9 and 12 months)
Changes in parental self-regulation over time	Parental self-regulation as assessed by two study-specific self-report items, rated on a 0-10 Likert scale. Higher scores indicate lower levels of parental self-regulation.	Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in parental co-regulation over time	Parental co-regulation as measured by three study-specific items assessing the parent's ability to support the child's emotional regulation. Items are rated on a 1-4 Likert scale, with higher scores indicating better parental co-regulation.	Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in perceived social support over time	Perceived social support, as measured by four study-specific items, rated on a 0-10 Likert scale. Higher scores indicate higher levels of perceived social support.	Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in parental reflective functioning, as measured by the parental reflective functioning questionnaire (PRFQ)	Parental reflective functioning as measured by the Interest & Curiosity (IC) and Certainty about Mental states (CMS) subscales of the PRFQ. CM assesses parents' confidence in understanding their child's mental states, while IC assesses active interest in and curiosity about the child's mental states. Items are scored on a 7-point Likert scale (1-7). Subscale scores are calculated by summing the item responses, with total scores for each subscale ranging from 7 to 42. For both subscales, higher scores indicate higher levels of the respective construct, however, extremely high or low scores may reflect maladaptive patterns (e.g., hypermentalizing or hypomentalizing).	Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in anxiety symptoms over time, as measured by the Generalized Anxiety Disorder scale (GAD-7)	Anxiety symptoms as measured by the Generalized Anxiety Disorder scale (GAD-7). Items are rated on a 4-point Likert scale (0-3). Total scores range from 0 to 21, with higher scores indicating higher levels of anxiety symptoms. Changes are assessed across all time points, including intervention effects and their maintenance over time.	Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in depressive symptoms over time, as measured by the Center of Epidemiologic Studies Depression Scale (CES-D 8).	Depressive symptoms as measured by the CES-D 8. Items are rated on a 4-point Likert scale (0-3). Total scores range from 0 to 24, with higher scores indicating higher levels of depressive symptoms. Changes are assessed across all time points, including intervention effects and their maintenance over time.	Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Changes in partner relationship satisfaction over time	Partner relationship satisfaction as measured by three study-specific items assessing partner support during stressful situations. Items are rated on a 1-4 Likert scale, with higher scores indicating greater perceived support and satisfaction in the relationship.	Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)
Child socio-emotional development at 6-month follow-up (infant age approximately 12 months)	Child socio-emotional development as measured by a 9-item parent-report questionnaire based on criteria from de Diagnostic Classification of Mental Health and Developmental Disorders of Infancy and Early Childhood (DC:0-5). Items are rated on a 5-point Likert scale (1-5). Total scores range from 9 to 45, with higher scores indicating better socio-emotional development.	6 months follow-up (infant age approximately 12 months)
Changes in parent-infant bonding, as measured by the Postpartum Bonding Questionnaire (PBQ)	Parent-infant bonding, as measured by the PBQ, a questionnaire consisting of 25 items. Items are rated on a 6-point Likert scale (0-5). Total scores range from 0 to 125, with higher scores indicating more impaired parent-infant bonding. Changes are assessed across all time points, including intervention effects and their maintenance over time.	Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: KU Leuven; Opgroeien
• Investigators: Principal Investigator: Edwin Wouters, Prof. Dr., Universiteit Antwerpen

Publications and helpful links

General Publications

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• Črnčec, R., Barnett, B., & Matthey, S. (2008). Development of an instrument to assess perceived self-efficacy in the parents of infants. Research in Nursing & Health, 31(5), 442-453. https://doi.org/10.1002/nur.20271
• van der Knoop, M., Schmidt, L., & Jansson, B. (2023). Translation and psychometric properties of the Dutch Parental Stress Scale. 7, 84-99.
• Berry, J. O., & Jones, W. H. (1995). The Parental Stress Scale: Initial Psychometric Evidence. Journal of Social and Personal Relationships, 12(3), 463-472. https://doi.org/10.1177/0265407595123009
• Luyten, P., Nijssens, L., Fonagy, P., & Mayes, L. C. (2017). Parental Reflective Functioning: Theory, Research, and Clinical Applications. The Psychoanalytic Study of the Child, 70(1), 174-199. https://doi.org/10.1080/00797308.2016.1277901
• Van de Velde, S., Levecque, K., & Bracke, P. (2009). Measurement equivalence of the CES-D 8 in the general population in Belgium: A gender perspective. Archives of Public Health, 67(1), 15-29. https://doi.org/10.1186/0778-7367-67-1-15

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Psychoeducation; Behavioral intervention; Infant mental health; Parental stress; Family intervention; Parental self-efficacy; Parenting support; Parental well-being; Early infancy; Infant regulatory problems; Parent-infant relationship; Regulatory problems in infancy; Parent-infant mental health
• Additional Relevant MeSH Terms: Musculoskeletal and Neural Physiological Phenomena; Nervous System Physiological Phenomena; Sleep
• Other Study ID Numbers: Antigoon ID48645; S003524N (Other Grant/Funding Number: FWO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A decision regarding sharing individual participant data (IPD) has not yet been finalized. The study team will consider data sharing options after study completion, taking into account participant privacy, ethical approvals, and potential collaborations with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No