Perspectives of Parents About Their Infants' Sleep
1 other identifier
observational
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 25, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedOctober 25, 2021
October 1, 2021
6 months
October 13, 2021
October 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Parental anxiety
Baseline
• Parental depression symptoms
Baseline
• Global relationship
baseline
• Married-life satisfaction scale
baseline
Parental Sleep quality
Baseline
- +2 more secondary outcomes
Study Arms (2)
Parents and their children with Behavioral insomnia
Parents and their children aged 6-36 months with sleep problems will be invited to participate into the study from Sleep Outpatient Clinic
Parents and their children without sleep problem
Parents and their children aged 6-36 months without sleep problems will be invited to participate into the study followed up in Well Child Clinic
Eligibility Criteria
\- Parents and their 6-36 months old children with and without sleep problems
You may qualify if:
- Parents and their 6-36 months old children
You may not qualify if:
- Divorced or separated couples
- Infants less than 37 weeks of gestational age
- Children with diagnosed developmental problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
October 13, 2021
First Posted
October 25, 2021
Study Start
November 1, 2021
Primary Completion
May 1, 2022
Study Completion
September 1, 2022
Last Updated
October 25, 2021
Record last verified: 2021-10