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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMarmara University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
6th, 12th, 18th and 36th months
2

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)

Time frame
6th, 12th and 18th months
3

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

Time frame
6th, 12th and 18th months

Secondary outcomes

1

Parental Reflective Functioning

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.

Time frame
6th, 12th, 18th and 36th months
2

Mother's Emotional Reactions

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.

Time frame
6th, 12th, 18th and 36th months
3

Temperament

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).

Time frame
18th and 36th months
4

Parental Stress Level

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.

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

Other outcomes

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