Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT07249593
Brief 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.
Detailed Description:
Regulatory difficulties in early childhood are commonly manifested as excessive crying in infants over three months old, and as feeding and sleep problems in infants over six months old. These difficulties are prevalent and are believed to be related to later problems with self-regulation. When sleep, feeding, and crying problems are considered together as regulation difficulties, prevalence estimates during the first year of life are approximately 20%, and co-occurrence of more than one regulation problem has been reported in 2-8% of cases. Although many early regulation difficulties are transient, they have been associated with later social and behavioral problems in childhood and with cognitive and behavioral difficulties in adulthood in longitudinal studies. Regulation difficulties are best understood within a transactional model in which infant temperament, caregiver behaviors, parental psychopathology, parental perceptions of infant behaviors, and broader sociocultural and environmental factors interact to shape infant sleep, feeding, and crying patterns. The dynamic relationship between parents and infants plays a critical role in the development of sleep problems. Whether the parent perceives the infant's sleep characteristics as problematic is influenced by many factors, and this, in turn, affects parental behaviors during the infant's nighttime awakenings. As a result, sleep problems are among the early regulation issues and are closely related to parent-child interactions. Parental sensitivity and parental reflective functioning (i.e., the caregiver's capacity to understand both their own and their child's mental states) are key proximal determinants of how regulation difficulties develop and how they are managed. Temperament and regulation difficulties overlap conceptually but are distinct constructs: temperament refers to biologically based individual differences in reactivity and self-regulation that evolve through reciprocal interactions with caregivers. Importantly, the relation between temperament and regulation difficulties is moderated by caregiving behaviors, highlighting the clinical importance of identifying temperament to provide tailored parenting recommendations. Caregiver-infant interaction during early childhood forms the foundation for social, emotional, and cognitive development. Caregiver sensitivity, defined as the ability to notice, accurately interpret, and promptly, consistently, and appropriately respond to infant signals (e.g., crying, smiling, gaze, and movement), is a major contributor to the development of healthy self-regulation. Parental reflective functioning (also referred to as parental mentalization, mind-mindedness, or insightfulness) describes the caregiver's capacity to consider the child's inner mental states and to view events from the child's perspective, and it is closely linked to sensitive caregiving. High caregiver sensitivity and reflective functioning support the child's ability to have their feelings and needs recognized and responded to, which may bolster the development of self-regulatory capacities.This study examines the relationship between caregivers' capacity to understand and interpret their infant's behaviors (i.e., parental reflective functioning and sensitivity) and infants' self-regulatory abilities, operationalized by sleep, feeding, and crying regulation measures. By clarifying these relationships, the research aims to inform interventions that enhance caregiver responsiveness and tailored caregiving strategies to reduce early regulation difficulties and their downstream developmental consequences.The primary aim of this study is to determine the effect of the parent's capacity to understand the infant's behaviors on regulation problems observed during early childhood (6-36 months). The secondary aims are to examine the emotional responses of mothers to infant crying and the mediating role of child and parent-related factors in this relationship. The research aims to contribute to the understanding of regulation problems through variables such as parental behaviors and child temperament characteristics.The study will be conducted through the online surveys, but it will be administered individually by the researcher, targeting the parents of infants in early childhood. This study adopts a longitudinal, prospective design. Mothers who have a 6 months old infant will be invited to participate. Recruitment will take place from December 2025 to March 2026. Mothers will be followed across four time points: 6, 12, 18, and 36 months of the child's age. Sociodemographic information will also be collected. Mothers will be assessed using the Parental Reflective Functioning Questionnaire, Parental Stress Scale, and My Emotions Questionnaire. The sleep of children will be evaluated by the Turkish version of the Revised-Brief Infant Sleep Questionnaire, feeding and crying problems will be assessed using the methodology established by Bilgin A. et al. Child's temperament will be assessed using the Early Childhood Behavior Questionnaire Very Short Form.
Study:
NCT07249593
Study Brief:
Protocol Section:
NCT07249593