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

Overview

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.

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-educato

Primary outcome measures

• Changes in parental self-efficacy, as measured by the Karitane Parenting Confidence Scale (KPCS), from baseline to post-intervention [Time frame: 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 [Time frame: Post-intervention (infant age approximately 6 months)]
• Infant regulatory problems at 6-month follow-up (infant age approximately 12 months) [Time frame: 6 months follow-up (infant age approximately 12 months)]

Secondary outcome measures (12)

• Changes in parental stress over time, as measured by the Parental Stress Scale (PSS; parental stress factor) [Time frame: 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) [Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)]
• Changes in infant regulatory problems over time [Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 9 and 12 months)]
• Changes in parental self-regulation over time [Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)]
• Changes in parental co-regulation over time [Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)]
• Changes in perceived social support over time [Time frame: 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) [Time frame: 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) [Time frame: 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). [Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)]
• Changes in partner relationship satisfaction over time [Time frame: 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) [Time frame: 6 months follow-up (infant age approximately 12 months)]
• Changes in parent-infant bonding, as measured by the Postpartum Bonding Questionnaire (PBQ) [Time frame: Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Belgium · 1 center

• University of Antwerp — Antwerp

Publications

• Crncec R, Barnett B, Matthey S. Development of an instrument to assess perceived self-efficacy in the parents of infants. Res Nurs Health. 2008 Oct;31(5):442-53. doi: 10.1002/nur.20271. PMID 18297638
• 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
• 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

Identifiers

NCT: NCT07541716 · Antigoon ID48645 · S003524N

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗