Parent-Related Factors Associated With Sleep in Young Children

NCT06769841 | Active Not Recruiting

• 1 other identifier: 09.2024.1086
• Study Type: observational
• Target: 475
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Sleep; Parenting; Parent-child Relations

Keywords

sleep; parent; infant

Outcome Measures

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. 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.

  3rd, 6th, 12th, 18th, 24th and 36th months

Secondary Outcomes (10)

• Prenatal co-parenting relationship

  Baseline

• Co-parenting relationship

  3rd, 6th, 12th, 18th, 24th and 36th months

• Maternal Self Efficacy

  3rd, 6th, 12th, 18th, 24th and 36th months

• Maternal and Paternal Depression Symptoms

  Baseline, 3rd, 6th, 12th, 18th, 24th and 36th months

• Paternal Involvement

  12th. And 36th. months

Eligibility Criteria

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

Study Population

Healthy pregnant women aged 18 and above and their partners

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University: lead
• E-BEBEK Retail Joint Stock Company: collaborator

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

Related Publications (15)

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  PMID: 33436342 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: January 21, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-06

Locations

TU (1)