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

NCT07541716 | Not Yet Recruiting

• 2 other identifiers: Antigoon ID48645S003524N
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Early infancy; Infant regulatory problems; Parental well-being; Parenting support; Behavioral intervention; Family intervention; Parent-infant relationship; Randomized controlled trial; Psychoeducation; Regulatory problems in infancy; Infant mental health; Parent-infant mental health; Parental stress; Parental self-efficacy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Changes in parental stress over time, as measured by the Parental Stress Scale (PSS; parental stress factor)

  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)

  Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)

• Changes in infant regulatory problems 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

  Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)

• Changes in parental co-regulation over time

  Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)

Study Arms (2)

Intervention arm

EXPERIMENTAL

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"

Control arm

NO INTERVENTION

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.

Interventions

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

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• KU Leuven: collaborator
• Opgroeien: collaborator

Study Sites (1)

University of Antwerp

Antwerp, 2000, Belgium

Location

Related Publications (6)

• 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

  BACKGROUND

• van der Knoop, M., Schmidt, L., & Jansson, B. (2023). Translation and psychometric properties of the Dutch Parental Stress Scale. 7, 84-99.

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

MeSH Terms

Interventions

Sleep

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Edwin Wouters, Prof. Dr.

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fien Plochaet

CONTACT

+3232652016; fien.plochaet@uantwerpen.be

Sara De Bruyn

CONTACT

sara.debruyn@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Edwin Wouters

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

BE (1)