Developing and Testing a Preventive Primary Care Parenting Intervention to Strengthen Parent-Infant Co-Regulation in Families Experiencing Early Regulatory Difficulties
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Universiteit Antwerpen
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Changes in parental self-efficacy, as measured by the Karitane Parenting Confidence Scale (KPCS), from baseline to post-intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention arm
Participants assigned to this condition will receive the six-week intervention program. They complete questionnaires during the 12-month study period.
Intervention: Structured early parenting support program, called "Eat, sleep, cry - repeat" (Behavioral)
Outcomes
Primary Outcomes
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.
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.
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
- 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))
- Changes in perceived social support over time(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)(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)(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).(Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months))
- Changes in partner relationship satisfaction over time(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)(6 months follow-up (infant age approximately 12 months))
- Changes in parent-infant bonding, as measured by the Postpartum Bonding Questionnaire (PBQ)(Baseline (approximately 4 months), post-intervention (approximately 6 months), and follow-up (approximately 12 months))
Investigators
Edwin Wouters
Prof. Dr. Edwin Wouters
Universiteit Antwerpen