Clinical trial NCT05092308: Perspectives of Parents About Their Infants' Sleep
Official title: Perspectives of Parents About Their Infants' Sleep: What do the Mothers Wish? What do the Fathers Think?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Insomnia
Keywords: sleep
insomnia
children
actigraphy
marital relationship
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Parents and their 6-36 months old children with and without sleep problems

Brief summary: Behavioral insomnia of childhood (BIC) is a common problem in early infancy. The whole family is affected by the problem, but research usually relies only on maternal perception and report. This mixed-method study aimed to explore maternal and paternal perspectives about their child's sleep and sleep problems in early childhood. Secondly, infants' sleep will be measured objectively with actigraphy. Parental mental health, marital relationship and sleep will be evaluated in order to explore the effects on the perception of their infant's sleep.

Detailed description: Sleep is essential for healthy growth and development of children. Behavioral insomnia of childhood is reported as a common sleep problem of early childhood with a prevalence of 26-68% according to the definition and study population.

Behavioral insomnia of childhood not only affects children's health but also has impacts on parental mental health and family functioning. Most studies on early childhood sleep problems rely on maternal report. However, both parents are affected by children's sleep problem. It is therefore essential for pediatric healthcare professional to understand both mothers' and fathers' perception and interpretation of their children's sleep and sleep problems in the context of family and culture to suggest culturally appropriate intervention according to the family's needs.

This study is designed to thematically analyze maternal and paternal perspectives of their child's sleep and sleep problems in early childhood.

Parents of children aged 6-36 months with and without sleep problems will be invited to participate into the study. Both parents of 10-15 children applying for sleep problems to Sleep Outpatient Clinic and both parents of 10-15 children followed up in Well Child Clinic without sleep problems will be included from October 2021 to June 2022. Semi-structured individual in depth interviews will be conducted with both mothers and fathers but in different sessions separately to explore parental views and perception of their child's sleep and sleep problems. The interviews are expected to last between 30-45 minutes and will be audio-recorded and transcribed for thematic analysis. Through these interviews the investigators will learn what kind of differences are present between the parents' perspectives of infants with and without sleep problems.

Sleep of all children will be evaluated by Turkish version of the expanded brief infant sleep questionnaire, actigraphy and sleep diary. Sociodemographic information will be collected. Parents in patient and control group will be assessed for the confounding factors by Patient Health Questionnaire-9, Generalized Anxiety Scale-7 test, Relationship Satisfaction Scale, Marital Life Satisfaction Scale and Pittsburgh Sleep Quality Index.

Eligibility criteria: Inclusion Criteria:

* Parents and their 6-36 months old children

Exclusion Criteria:

* Divorced or separated couples
* Infants less than 37 weeks of gestational age
* Children with diagnosed developmental problems

Primary outcomes:
measure: Perspectives of parents on infant sleep
timeFrame: Baseline
Secondary outcomes:
measure: Parental anxiety
timeFrame: Baseline
measure: • Parental depression symptoms
timeFrame: Baseline
measure: • Global relationship
timeFrame: baseline
measure: • Married-life satisfaction scale
timeFrame: baseline
measure: Parental Sleep quality
timeFrame: Baseline
measure: Infant sleep wake patterns
timeFrame: Baseline
measure: Infant sleep parameters
timeFrame: Baseline
Other outcomes:
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