Parent-Related Factors Associated with Sleep in Young Children

Not yet recruiting

• Conditions: Child Sleep; Parenting; Parent-child Relations

• Registration Number: NCT06769841
• Lead Sponsor: Marmara University

Brief Summary

Sleep plays a crucial role in supporting a child's healthy development, growth, and overall well-being. While many children develop healthy sleep patterns, 20-30% of infants experience sleep problems. Beyond biological processes, sleep is influenced by environmental, psychosocial, and cultural factors.

Understanding the relationship between parental factors and child sleep-wake patterns, alongside identifying potential developmental shifts during this period, is essential. However, existing research, often limited to cross-sectional or short-term longitudinal studies, has mostly focused on mothers, with few studies considering the transactional nature between infants' sleep patterns and the bidirectional influences exerted by other important parental factors.

This longitudinal study aims to understand how parent-infant interactions influence infant sleep patterns across the first three years of life for both mothers and fathers. The study will further examine the effects of parental factors, including (1) the co-parenting relationship, (2) maternal self-efficacy, (3) maternal/paternal depression, (4) maternal/paternal anxiety, (5) paternal involvement, (6) maternal/paternal sleep, and (7) parental stress, along with child factors such as temperament and socio-emotional development, on infants' sleep-wake patterns. Additionally, this study will investigate the dynamic, bidirectional relationships between these factors, providing valuable insights into infant and family well-being.

Detailed Description

Sleep is a physiological process for a child's healthy development, growth, and well-being. Although child sleep regulation across the early years proceeds well for many, estimates of sleep problems among infants range between 20-30%.

Beyond biological processes, sleep is influenced by environmental, psychosocial, and cultural factors. According to the transactional model, infant sleep is shaped through a bidirectional, continuous, and complex relationship between internal factors related to the infant (such as temperament) and factors related to the parents (such as parental mental health, sleep-related behaviors, and the quality of their relationship with the child). Cultural factors also play a significant role in shaping children's sleep patterns, influencing both their sleep habits and parents' approaches to addressing sleep issues. Understanding how parental factors and child sleep interact and evolve each other during the early years is vital for supporting the well-being of both infants and their families.

The primary objective of this study is to determine how parent-infant interactions influence changes in infant sleep patterns over the first three years of life, enabling the examination of bidirectional linkages and within-person associations between variations in parent and infant sleep. The second objective is to identify predictors of the relationship between parent and child sleep. Moreover, this study will enable the investigators to establish a birth cohort, which will serve as a valuable resource for addressing future research questions and advancing knowledge in this field.

This study adopts a longitudinal, prospective design. Families who are pregnant with first child in the second or third trimester will be invited to participate. Recruitment will take place from January to December 2025. Parents will be followed across seven time points: during pregnancy (second or third trimester) and at 3, 6, 12, 18, 24, and 36 months postpartum.

Sociodemographic information also will be collected. Parents will be assessed by Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Pittsburgh Sleep Quality Index, Coparenting Relationship Scale, Maternal Self-Efficacy Scale, Parental Stress Scale, Paternal Involvement Questionnaire. Sleep of children will be evaluated by the Turkish version of the expanded brief infant sleep questionnaire and the infant's social and emotional development will be assessed by Brief Infant Toddler Social Emotional Assessment. Child's temperament will be assessed with one question.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Study Start: 2025-01-21
• Primary Completion: 2028-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

• Being pregnant with the first child Gestational age>12 weeks Parents over the age 18 Fluent in Turkish Parents living in Istanbul

Exclusion Criteria

• Suicidal ideation in Patient Health Questionnaire-9 (PHQ-9) No internet access

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infant sleep-wake patterns	3rd, 6th, 12th, 18th, 24th 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. 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.

Secondary Outcome Measures

Name	Time	Method
Prenatal co-parenting relationship	Baseline	To evaluate prenatal coparenting relationships, the Coparenting Relationship Scale - Father's Prenatal Version will be used for both mother and fathers. The survey predicts that individuals with higher scores are more likely to have positive coparenting relationships in the future. The minimum score that can be obtained from the scale is 30, while the maximum score is 210.
Co-parenting relationship	3rd, 6th, 12th, 18th, 24th and 36th months	To evaluate coparenting relationships, the Coparenting Relationship Scale will be used which predicts that individuals with higher scores are more likely to have positive coparenting relationships. The minimum score that can be obtained from the scale is 0, while the maximum score is 150. The survey has been validated in Turkish.
Maternal Self Efficacy	3rd, 6th, 12th, 18th, 24th and 36th months	To evaluate maternal self efficacy, Maternal Self Efficacy Scale will be used. The survey is a ten item scale and a higher score on the scale indicates a higher level of maternal self-efficacy. The minimum score that can be obtained from the scale is 10, while the maximum score is 40. The survey has been validated in Turkish.
Maternal and Paternal Depression Symptoms	Baseline, 3rd, 6th, 12th, 18th, 24th and 36th months	Parental depression symptoms will be measured with Patient Health Questionnaire-9. This nine-item scale is designed to assess the presence and severity of depressive symptoms. Based on the scale, scores of 0-4 indicate no depression, 5-9 indicate mild depression, and 10 or above reflect a high level of depression. The survey has been validated in Turkish.
Paternal Involvement	12th. And 36th. months	The Father Involvement Scale will be used to evaluate paternal involvement. This 37-item scale, scored using a 5-point Likert system, was developed for fathers with children aged 3 to 6 years. The survey assesses the frequency of one-on-one activities fathers engage in with their children and consists of three subscales: Playful Interaction, Basic Care, and Affection and Closeness. When the child is 12 months old, fathers will complete only the Basic Care and Affection and Closeness subscales, as these are more suitable for the child's age. At 36 months postpartum, fathers will be asked to complete the entire scale. Total scores range from a minimum of 37 to a maximum of 185, with higher scores indicating a greater level of paternal involvement.
Maternal and Paternal Sleep Quality	Baseline, 3rd, 6th, 12th, 18th, 24th and 36th months	To evaluate maternal and paternal sleep, Pittsburgh Sleep Quality Index(PUKI) will be used. This survey is a 19-item self-report scale that evaluates sleep quality and disturbances over the past month. The total score ranges from 0 to 21. Higher scores on the scale are associated with lower sleep quality. The survey has been validated in Turkish.
Parental Stress	3rd, 6th, 12th, 18th, 24th and 36th months	To evaluate parental stress, the Parental Stress Scale will be used. This survey is a 16-item, 5-point Likert-type scale consisting of the subscales: Parental Rewards, Parental Stressors, Lack of Control, and Parental Satisfaction. In our study, only questions from the parental stressors subscale of the survey will be used. Higher scores indicate greater parental stress. The minimum score that can be obtained from the scale is 16, while the maximum score is 80. The survey has been validated in Turkish.
Child's Temperament	3rd, 6th, 12th, 18th, 24th and 36th months	Mothers and fathers will be asked to assess their baby's temperament with the question, "How would you evaluate your baby's temperament?" This will be rated on a 5-point Likert scale, with "1: Very easy" and "5: Very difficult."
Maternal and Paternal Anxiety	Baseline, 3rd, 6th, 12th, 18th, 24th and 36th months	Maternal and paternal anxiety will be measured with Generalized Anxiety Scale-7. Scores on the scale are categorized as follows: 0-4 indicates mild anxiety, 5-9 moderate anxiety, 10-14 high anxiety, and 15-21 severe anxiety, with a cutoff score of 8 or higher. The survey has been validated in Turkish.
Infant's Social and Emotional Development	12th., 18th., 24th. and 36th months	Social and emotional development will be assessed using the Brief Infant Toddler Social Emotional Assessment (BITSEA), which comprises two domains: the Problem Scale, consisting of 31 items, and the Competence Scale, consisting of 11 items. Items are rated on a 3-point scale: 0 (not true/rarely), 1 (somewhat true/sometimes), and 2 (very true/often). The total score ranges from 0 to 62 for the Problem Scale and from 0 to 22 for the Competence Scale. Higher scores on the Problem Scale indicate a greater risk of emotional and behavioral problems, while lower scores on the Competence Scale suggest an increased risk of competence deficits or developmental delays. The survey has been validated in Turkish.