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

NCT ID: NCT07249593

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 249 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-11
• Study Completion Date: 2029-03-01

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.

Conditions

Regulation, Self; Reflective Functioning; Mentalization; Child Sleep; Parent-Child Relation; Crying; Feeding Problems

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Perran Boran

Professor of Pediatrics, Division of Social Pediatrics, Marmara University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marmara University

Istanbul, , Turkey (Türkiye)

Site Status: NOT_YET_RECRUITING

Marmara University

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Betul Senyurek

Role: CONTACT

betulsenyurek@marun.edu.tr

+905365917777

Facility Contacts

BETÜL

Role: primary

betulakbay1@gmail.com

05365917777

References

Gördesli, M. A., & Sünbül, Z. A. (2021). The psychometric properties of parental stress scale-Turkish Form. Turkish Psychological Counseling and Guidance Journal, 11(61), 199-213.

Reference Type: BACKGROUND

Putnam SP, Gartstein MA, Rothbart MK. Measurement of fine-grained aspects of toddler temperament: the early childhood behavior questionnaire. Infant Behav Dev. 2006 Jul;29(3):386-401. doi: 10.1016/j.infbeh.2006.01.004. Epub 2006 Mar 2.

Reference Type: BACKGROUND

PMID: 17138293 (View on PubMed)

Arikan G, Acar IH, Ustundag-Budak AM. A two-generation study: The transmission of attachment and young adults' depression, anxiety, and social media addiction. Addict Behav. 2022 Jan;124:107109. doi: 10.1016/j.addbeh.2021.107109. Epub 2021 Sep 3.

Reference Type: BACKGROUND

PMID: 34547644 (View on PubMed)

Baris HE, Us MC, Boran P. Turkish adaptation of the maternal cognition about infant sleep questionnaire. Sleep Med X. 2023 Dec 29;7:100102. doi: 10.1016/j.sleepx.2023.100102. eCollection 2024 Dec.

Reference Type: BACKGROUND

PMID: 38268570 (View on PubMed)

Grienenberger JF, Kelly K, Slade A. Maternal reflective functioning, mother-infant affective communication, and infant attachment: exploring the link between mental states and observed caregiving behavior in the intergenerational transmission of attachment. Attach Hum Dev. 2005 Sep;7(3):299-311. doi: 10.1080/14616730500245963.

Reference Type: BACKGROUND

PMID: 16210241 (View on PubMed)

Slade A, Grienenberger J, Bernbach E, Levy D, Locker A. Maternal reflective functioning, attachment, and the transmission gap: a preliminary study. Attach Hum Dev. 2005 Sep;7(3):283-98. doi: 10.1080/14616730500245880.

Reference Type: BACKGROUND

PMID: 16210240 (View on PubMed)

Meins E, Fernyhough C, Fradley E, Tuckey M. Rethinking maternal sensitivity: mothers' comments on infants' mental processes predict security of attachment at 12 months. J Child Psychol Psychiatry. 2001 Jul;42(5):637-48.

Reference Type: BACKGROUND

PMID: 11464968 (View on PubMed)

Koren-Karie N, Oppenheim D, Yuval-Adler S, Mor H. Emotion dialogues of foster caregivers with their children: the role of the caregivers, above and beyond child characteristics, in shaping the interactions. Attach Hum Dev. 2013;15(2):175-88. doi: 10.1080/14616734.2013.746822. Epub 2012 Nov 27.

Reference Type: BACKGROUND

PMID: 23186141 (View on PubMed)

Leerkes EM, Qu J. The My Emotions Questionnaire: A self-report of mothers' emotional responses to infant crying. Infant Ment Health J. 2020 Jan;41(1):94-107. doi: 10.1002/imhj.21830. Epub 2019 Sep 11.

Reference Type: BACKGROUND

PMID: 31508839 (View on PubMed)

Ainsworth, M. D. S., Blehar, M. C., Waters, E., & Wall, S. N. (2015). Patterns of attachment: A psychological study of the strange situation. Psychology press.

Reference Type: BACKGROUND

Sidor A, Fischer C, Cierpka M. The link between infant regulatory problems, temperament traits, maternal depressive symptoms and children's psychopathological symptoms at age three: a longitudinal study in a German at-risk sample. Child Adolesc Psychiatry Ment Health. 2017 Mar 6;11:10. doi: 10.1186/s13034-017-0148-5. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28286548 (View on PubMed)

Stuhrmann LY, Gobel A, Bindt C, Mudra S. Parental Reflective Functioning and Its Association With Parenting Behaviors in Infancy and Early Childhood: A Systematic Review. Front Psychol. 2022 Mar 3;13:765312. doi: 10.3389/fpsyg.2022.765312. eCollection 2022.

Reference Type: BACKGROUND

PMID: 35310277 (View on PubMed)

Leerkes EM. Predictors of Maternal Sensitivity to Infant Distress. Parent Sci Pract. 2010 Jul 1;10(3):219-239. doi: 10.1080/15295190903290840.

Reference Type: BACKGROUND

PMID: 20824194 (View on PubMed)

Sadeh A, Tikotzky L, Scher A. Parenting and infant sleep. Sleep Med Rev. 2010 Apr;14(2):89-96. doi: 10.1016/j.smrv.2009.05.003. Epub 2009 Jul 23.

Reference Type: BACKGROUND

PMID: 19631566 (View on PubMed)

Wolke D, Baumann N, Jaekel J, Pyhala R, Heinonen K, Raikkonen K, Sorg C, Bilgin A. The association of early regulatory problems with behavioral problems and cognitive functioning in adulthood: two cohorts in two countries. J Child Psychol Psychiatry. 2023 Jun;64(6):876-885. doi: 10.1111/jcpp.13742. Epub 2023 Jan 5.

Reference Type: BACKGROUND

PMID: 36601777 (View on PubMed)

Bilgin A, Baumann N, Jaekel J, Breeman LD, Bartmann P, Bauml JG, Avram M, Sorg C, Wolke D. Early Crying, Sleeping, and Feeding Problems and Trajectories of Attention Problems From Childhood to Adulthood. Child Dev. 2020 Jan;91(1):e77-e91. doi: 10.1111/cdev.13155. Epub 2018 Oct 6.

Reference Type: BACKGROUND

PMID: 30291757 (View on PubMed)

Hemmi MH, Wolke D, Schneider S. Associations between problems with crying, sleeping and/or feeding in infancy and long-term behavioural outcomes in childhood: a meta-analysis. Arch Dis Child. 2011 Jul;96(7):622-9. doi: 10.1136/adc.2010.191312. Epub 2011 Apr 20.

Reference Type: BACKGROUND

PMID: 21508059 (View on PubMed)

Bilgin A, Wolke D. Regulatory Problems in Very Preterm and Full-Term Infants Over the First 18 Months. J Dev Behav Pediatr. 2016 May;37(4):298-305. doi: 10.1097/DBP.0000000000000297.

Reference Type: BACKGROUND

PMID: 27096573 (View on PubMed)

Other Identifiers

27.05.2025-46

Identifier Type: -

Identifier Source: org_study_id