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

December 12, 2025 updated by: Perran Boran, Marmara University

Parental Recognition of Child Needs and Its Impact on Early Childhood Regulatory Problems

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

249

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Not yet recruiting
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant sleep-wake patterns
Time Frame: 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.
6th, 12th, 18th and 36th months
Infant Crying
Time Frame: 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)
6th, 12th and 18th months
Feeding
Time Frame: 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
6th, 12th and 18th months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Reflective Functioning
Time Frame: 6th, 12th, 18th and 36th months
Parental Reflective Functioning will be measured using the Parental Reflective Functioning Questionnaire (PRFQ). The PRFQ is an 18 item parent report instrument with three subscales: Interest and Curiosity (IC), Certainty about Mental States (CMS), and Pre mentalizing Modes (PM). Items are rated on a 7 point Likert scale (1 = strongly disagree to 7 = strongly agree). Subscale scores reflect distinct aspects of parental mentalizing (IC: interest in the child's mental states; CMS: tolerance of uncertainty about mental states; PM: non mentalizing or maladaptive attributions), and higher scores have different interpretations depending on the subscale. The measure has demonstrated acceptable internal consistency in validation studies and a validated Turkish short form is available.
6th, 12th, 18th and 36th months
Mother's Emotional Reactions
Time Frame: 6th, 12th, 18th and 36th months
My Emotions Questionnaire (MEQ) will be used to assess mothers' emotional responses to infant crying. The MEQ is a 20 item parent report measure comprising five subscales: Amusement, Anxiety, Frustration, Sympathy, and Protective. Items are summed to produce subscale and total scores (range 20-100); higher scores indicate more frequent or problematic emotional responses. A Turkish reliability and validity study of this questionnaire will be conducted concurrently. Permission for use and ethics committee approval has been obtained.
6th, 12th, 18th and 36th months
Temperament
Time Frame: 18th and 36th months
Early Childhood Behavior Questionnaire - Very Short Form (ECBQ VSF) will be administered as a parent report measure of temperament for children aged 18th and 36th months. The ECBQ VSF contains 36 items rated on a 7 point Likert scale (1 = never to 7 = always) and yields three subscale scores: Negative Affectivity, Surgency (Extraversion), and Effortful Control. Each subscale score is calculated as the mean of its constituent item scores (items requiring reverse scoring should be recoded prior to averaging). Higher scores indicate greater expression of the corresponding temperament dimension (e.g., higher Negative Affectivity -more frequent/intense negative emotion; higher Effortful Control = stronger self regulation).
18th and 36th months
Parental Stress Level
Time Frame: 6th, 12th, 18th and 36th months
Parenting Stress Scale (PSS) will be used for parent reported measure of parenting stress. The PSS is a 16 item, 5 point Likert scale (1 = strongly disagree to 5 = strongly agree) that assesses perceived stress related to parenting. Total scores range from 16 to 80, with higher scores indicating greater parenting stress. The scale is organized into four subscales: Parental Rewards, Parental Stressors, Lack of Control and Parental Satisfaction. The maximum score is 80, and the minimum score is 16. Higher scores indicate more problematic responses.
6th, 12th, 18th and 36th months
Behavior
Time Frame: 18th and 36th months
Early Childhood Behavior Questionnaire - Very Short Form (ECBQ VSF) will be administered as a parent report measure of temperament for children aged 18th and 36th months (19). The ECBQ VSF contains 36 items rated on a 7 point Likert scale (1 = never to 7 = always) and yields three subscale scores: Negative Affectivity, Surgency (Extraversion), and Effortful Control. Each subscale score is calculated as the mean of its constituent item scores (items requiring reverse scoring should be recoded prior to averaging). Higher scores indicate greater expression of the corresponding temperament dimension (e.g., higher Negative Affectivity -more frequent/intense negative emotion; higher Effortful Control = stronger self regulation).
18th and 36th months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2025

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Estimated)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27.05.2025-46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Requests for wider sharing of data (for example in response to information on Marmara University webpages and in publications about the study and willingness to share), will be addressed on a case-by-case basis. Any data sharing request will be made to investigators through a pre-defined data requisition form. This form will contain information about the applicant, institution, purpose of data request, study objectives, ethical clearance of the study, etc. Once a request has been made the data governance body will discuss if that request was appropriate and meets the criteria set by the university; data will be released following signing of the data sharing agreement. The data will be stored on the Marmara University servers and not be deposited in any 'community' database.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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