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

NCT07249593 | Recruiting

• 1 other identifier: 27.05.2025-46
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

regulatory problems; maternal sensitivity; sleep; feeding; crying; Parental reflective functioning; Mentalization; Insightfulness

Outcome Measures

Primary Outcomes (3)

• Infant sleep-wake patterns

  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.

  6th, 12th, 18th and 36th months

• Infant Crying

  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)

  6th, 12th and 18th months

• Feeding

  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

  6th, 12th and 18th months

Secondary Outcomes (5)

• Parental Reflective Functioning

  6th, 12th, 18th and 36th months

• Mother's Emotional Reactions

  6th, 12th, 18th and 36th months

• Temperament

  18th and 36th months

• Parental Stress Level

  6th, 12th, 18th and 36th months

• Behavior

  18th and 36th months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy mothers aged 18 and above and her healthy children 0-36 months

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Marmara University: lead

Study Sites (2)

Marmara University

Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

Marmara University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (18)

• 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.

  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.

  PMID: 17138293 BACKGROUND

• 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.

  PMID: 34547644 BACKGROUND

• 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.

  PMID: 38268570 BACKGROUND

• 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.

  PMID: 16210241 BACKGROUND

• 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.

  PMID: 16210240 BACKGROUND

• 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.

  PMID: 11464968 BACKGROUND

• 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.

  PMID: 23186141 BACKGROUND

• 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.

  PMID: 31508839 BACKGROUND

• 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.

  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.

  PMID: 28286548 BACKGROUND

• 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.

  PMID: 35310277 BACKGROUND

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

  PMID: 20824194 BACKGROUND

• 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.

  PMID: 19631566 BACKGROUND

• 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.

  PMID: 36601777 BACKGROUND

• 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.

  PMID: 30291757 BACKGROUND

• 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.

  PMID: 21508059 BACKGROUND

• 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.

  PMID: 27096573 BACKGROUND

MeSH Terms

Conditions

Self-Control; Crying

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Nonverbal Communication; Communication

Central Study Contacts

Betul Senyurek

CONTACT

+905365917777; betulsenyurek@marun.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Division of Social Pediatrics, Marmara University School of Medicine

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: December 15, 2025

Record last verified: 2025-09

Locations

TU (2)