Ireland
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Active, not recruiting Observational

Recognizing Children's Needs: Impact on Early Childhood Regulatory Problems

NCT07249593 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-12-11
Last updated
2026-08-05

Condition(s) studied

Regulation, SelfReflective FunctioningMentalizationChild SleepParent-Child RelationCryingFeeding Problems

Study summary

Brief Summary:

This study aims to quantitatively examine the relationship between regulatory problems (sleep, feeding, and crying) in infants aged 6-36 months and levels of parental sensitivity and reflective functioning. The primary objective is to determine how parents' ability to perceive and interpret their child's cues affects these regulatory difficulties; the secondary objective is to explore how emotional responses to crying and other parent-child interaction factors mediate that relationship. In a cohort of approximately 249 infant-parent dyads, the Revised-Brief Infant Sleep Questionnaire (BISQ-R), feeding and crying assessment forms, the Parental Reflective Functioning Questionnaire, the My Emotions Questionnaire, and the Parental Stress Scale will be administered. Data will be analyzed via descriptive statistics, correlation analyses, and multiple regression models. As the first large-scale quantitative study in Turkey to investigate this area, it will yield unique data to guide parenting programs and early-intervention policies.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Participants aged 18 years and older with a infant aged 6 months (± 1 month) * Willingness to participate in the study and follow-up * Ability to speak, understand and communicate fluently in Turkish. Exclusion Criteria: * Mothers of infants with serious chronic conditions requiring follow-up, diagnosed after birth, even if included in the study * Individuals who completed the questionnaire but did not meet the questionnaire reliability criteria * Parents of babies with a history of preterm birth (gestational age under 37 weeks) * Parents of babies with a history of low birth weight (\<2500g)

Primary outcome measure(s)

  • Infant sleep-wake patterns — 6th, 12th, 18th and 36th months
    Infant sleep-wake patterns will be measured using the Revised-Brief Infant Sleep Questionnaire (BISQ-R). The BISQ-R is a parent-reported screening tool designed to evaluate sleep patterns in infants and young children. This scale consists of 33 questions with 19 questions for scoring. There are 3 subscales including infant sleep, parent perception, and parent behavior. The total and each subscale score ranges from 0 to 100. The total score is the average of the 3 subscale scores. Higher scores indicate better sleep quality, more positive perception of infant sleep, and parental behaviors that promote healthy and independent sleep. The survey has been validated in Turkish.
  • Infant Crying — 6th, 12th and 18th months
    Crying: In the present study, the assessment of crying will be conducted in accordance with the methodology employed in the research conducted by Bilgin A. et al.. A child will be considered to have a crying problem if at least one of the following three measures is present: * At 6 months: 1. Crying for 120 minutes or more (assessed as Yes/No) 2. Difficulty or great difficulty soothing the baby (Easy/Difficult) 3. Mother perceives the crying as disturbing (assessed as Yes/No) * At 12 months: 1. Crying for 60 minutes or more (assessed as Yes/N(note: this data is not available in the Bilgin A.'s study-only collected at 0, 3, 6, and 18 months)o) 2. Difficulty or great difficulty soothing the baby (Easy/Difficult) 3. Mother perceives the crying as disturbing (assessed as Yes/No) * At 18 months: 1. Crying for 60 minutes or more (assessed as Yes/No) 2. Difficulty or great difficulty soothing the baby (Easy/Difficult) 3. Mother perceives the crying as disturbing (assessed as Yes/No)
  • Feeding — 6th, 12th and 18th months
    Feeding: In the present study, the feeding will be assessed in accordance with the methodology employed by Bilgin A. et al. Feeding problems will be evaluated in participants using two general items. This section will assess selective eating/food refusal. * At 6 months: fighting with breast/bottle will be assessed (Yes/No). * At 12 and 18 months: selective eating/food refusal will be assessed by asking the following items (Yes/No for each): 1. eating very little 2. leaving most of the food offered 3. lack of appetite 4. being selective about foods 5. eating slowly 6. refusing lumpy/textured foods 7. even refusing pureed foods

Trial sites (1)

FacilityCityRegionStatus
Marmara University Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07249593 on ClinicalTrials.gov ↗ ← All trials in Turkey