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.
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.
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
Parallel
Structured early parenting support program, called "Eat, sleep, cry - repeat"
BehavioralThe 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.
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.
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.
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.
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.
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.
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.
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.
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