Clinical trial NCT04926064: Young Children's Sleep Patterns and Problems Among Turkish Children
Official title: Young Children's Sleep Patterns and Problems Among Turkish Children: Cross-sectional Study From a Nationally Representative Sample
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Behavior Problem
Keywords: sleep
insomnia
children
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 2434
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: mothers of healthy infants aged between 6 to 36 months

Brief summary: Sleep is important for optimal child growth, development, and family functioning. Behavioral pediatric insomnia is one of the most prevalent sleep disorders identified in young children. Well-child visits represent an important setting for addressing concerns regarding the child's sleep patterns and sleep problems.

Investigators aimed to describe sleep/wake patterns of young children, evaluate the associations between parental depressive, and anxiety symptoms, parental involvement in child-care, sleep-related behaviors and children's sleep parameters.

The study has a descriptive cross-sectional study design. An estimated sample size was 2089 participants considering the number of children aged between 6-36 months in the country, and the estimated prevalence of Behavioral Insomnia being 30%. A multi-stage stratification is used to calculate the number of participants to be taken at the level of 12 geographical regions according to Nomenclature of Territorial Units for Statistics (NUTS-1). A sleep study group is established by the study coordinator, and researchers running a well-child outpatient clinic from each region across the country are included.

Investigators invite mothers of children aged 6 to 36 months who either visited for a well-child outpatient clinic or in the waiting list for follow up to complete the online questionnaire about their children's sleep/wake patterns utilizing mailing lists obtained from the outpatient clinics. Recruitment will take place from April to June 2021. The questionnaire included Brief Infant Sleep Questionnaire (BISQ), Edinburgh Postnatal Depression Scale (EPDS) and Generalized Anxiety Disorder (GAD-7) scale, and separate questions on fathers' involvement in child care, and sociodemographic characteristics. An online google survey is developed on the google platform securing data collection by a confidential log in system which can be filled out from smartphones, tablet or computer. The questionnaire takes approximately 20 minutes to complete.

Detailed description: Sleep is important for optimal child growth, development, and family functioning. Behavioral pediatric insomnia is one of the most prevalent sleep disorders identified in young children. Well-child visits represent an important setting for addressing concerns regarding the child's sleep patterns and sleep problems.

Investigators aimed to describe sleep/wake patterns of young children, evaluate the associations between parental depressive, and anxiety symptoms, parental involvement in child-care, sleep-related behaviors and children's sleep parameters.

The study has a descriptive cross-sectional study design. According to the formula for the known number of individuals in the universe \[Sample formula with known number of individuals n = \[Np(1-p)\]/ \[(d2/Z21-α/2\*(N-1)+p\*(1-p)\], (α=0.05, p=0.32, d=0.02) the sample size to represent the population was found to be 2089, considering the number of children aged between 6-36 months in the country, and the estimated prevalence of Behavioral Insomnia being 30%. A multi-stage stratification is used to calculate the number of participants to be taken at the level of 12 geographical regions according to Nomenclature of Territorial Units for Statistics (NUTS-1). A sleep study group is established by the study coordinator, and researchers running a well-child outpatient clinic from each region across the country are included.

Investigators invite mothers of children aged 6 to 36 months who either visited for a well-child outpatient clinic or in the waiting list for follow up to complete the online questionnaire about their children's sleep/wake patterns utilizing mailing lists obtained from the outpatient clinics. Recruitment will take place from April to June 2021. The questionnaire included Brief Infant Sleep Questionnaire (BISQ), Edinburgh Postnatal Depression Scale (EPDS) and Generalized Anxiety Disorder (GAD-7) scale, and separate questions on fathers' involvement in child care, and sociodemographic characteristics. An online google survey is developed on the google platform securing data collection by a confidential log in system which can be filled out from smartphones, tablet or computer. The questionnaire takes approximately 20 minutes to complete.

Eligibility criteria: Inclusion Criteria:

* mothers of healthy infants aged between 6 to 36 months

Exclusion Criteria:

infants \<37 gestational week, congenital disease, neurodevelopmental disorder, use of drugs that can affect sleep such as diphenhydramine, Obstructive Sleep Apnea diagnosis

Primary outcomes:
measure: Sleep wake patterns
timeFrame: Baseline
measure: Sleep problem
timeFrame: Baseline
Secondary outcomes:
measure: maternal depression
timeFrame: Baseline
measure: maternal anxiety
timeFrame: baseline
measure: paternal involvement in child care
timeFrame: baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
Study officials:
References: