Perspectives of Parents About Their Infants' Sleep

Insomnia Clinical Trial

Official title:

Perspectives of Parents About Their Infants' Sleep: What do the Mothers Wish? What do the Fathers Think?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05092308
• Other study ID #: 09.2021.719
• Status: Not yet recruiting
• Start date: November 2021
• Est. completion date: September 2022

Study information

• Verified date: October 2021
• Source: Marmara University
• Contact: Perran Boran
• Phone: +905417127756
• Email: drperran[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2022
• Est. primary completion date: May 2022
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perspectives of parents on infant sleep	The semi- structured individual interviews will be conducted with mothers and fathers of infants with and without sleep problems. Both parents of an infant will be interviewed in different sessions to detect any discrepancies between their opinions. The topic guide will include parental views, perceptions and interpretations of their infants' sleep and expectations regarding interventions.	Baseline
Secondary	Parental anxiety	• Parental anxiety will be measured with Generalized anxiety scale-7. It is a seven item scale developed to screen for anxiety in general in primary care settings. The questionnaire score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. Cut off score for Turkish validation has been set at 8.	Baseline
Secondary	• Parental depression symptoms	• Parental depression symptoms will be measured with Patient Health Questionnaire-9. It is a nine item scale used to screen for the presence and severity of depressive symptoms. As a severity measure, the PHQ-9 score ranges from 0 to 27, with each of the nine items scored from 0 (not at all) to 3 (nearly every day). A score of 10 or above indicates depressive disorder. Turkish validation has been done.	Baseline
Secondary	• Global relationship	• Global relationship will be measured with Relationship Assessment Scale. This is a brief measure of global relationship satisfaction, which consists of seven items, each rated on a five-point Likert scale, ranging from 1 (not well), to 5 (very well). The scale is suitable to use with any individuals who are in an intimate relationship such as married couples or cohabiting couples.	baseline
Secondary	• Married-life satisfaction scale	• Married-life satisfaction scale is a 5-item scale developed to measure married life satisfaction. Higher scores indicate better marital satisfaction.	baseline
Secondary	Parental Sleep quality	• Parental sleep quality will be measured with Pittsburgh sleep quality index. It is a questionnaire which assesses sleep disturbances over a 1-month time interval. If the PUKI global score is greater than 5, it indicates poor sleep quality. Turkish validation has been done.	Baseline
Secondary	Infant sleep wake patterns	• Infants sleep wake patterns will be measured with actigraphy. Actigraphy is a wrist-watch like device that continuously measures motion and estimates sleep-wake patterns by measuring motion in natural settings. It is a valid method to objectively assess infants' sleep. Sleep wake patterns will be assessed by Philips Respironics Mini-Mitter Actiwatch-2 for 3 days at home environment and sleep diaries within 5-minute intervals will be filled out by parents simultaneously. The following actigraphic sleep metrics will be used: 1) wake after sleep onset (WASO); 1) sleep of latency (SOL); and 3) number of awakenings (NW), sleep duration, sleep efficiency.	Baseline
Secondary	Infant sleep parameters	• Infant sleep parameters will be measured by Expanded-Brief Infant Sleep Questionnaire (BISQ) :BISQ is a screening questionnaire for sleep in infants and young children. Variables include nocturnal sleep duration, daytime sleep duration, number of night awakenings, duration of night time wakefulness, nocturnal sleep onset time, settling time, method of falling asleep, location of sleep. If the child woke up more than 3 times per night, spent more than 1 hour in wakefulness during the night, or spent less than 9 hours in sleep (day and night), then they were considered as poor sleepers	Baseline