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NCT Number: NCT07541716

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Antwerp

Antwerp, 2000, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. Infant regulatory problems at 6-month follow-up (infant age approximately 12 months)

    Time frame: 6 months 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.

Secondary outcomes

  1. 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)

    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.

  2. 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)

    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.

  3. 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)

    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.

  4. Changes in parental self-regulation over time

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

    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.

  5. Changes in parental co-regulation over time

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

    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.

  6. Changes in perceived social support over time

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

    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.

  7. 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)

    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).

  8. 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)

    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.

  9. 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)

    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.

  10. Changes in partner relationship satisfaction over time

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

    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.

  11. 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)

    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.

  12. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fien Plochaet

CONTACT

[email protected]

+3232652016

Sara De Bruyn

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • KU Leuven
  • Opgroeien

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 21, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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