InsomniaNCT05092308
Perspectives of Parents About Their Infants' Sleep
An observational study of Insomnia, run by Marmara University.
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. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Insomnia
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- Child
Study population: - Parents and their 6-36 months old children with and without sleep problems
Who may be able to join
- Parents and their 6-36 months old children
Who cannot join
- Divorced or separated couples
- Infants less than 37 weeks of gestational age
- Children with diagnosed developmental problems
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Perspectives of Parents About Their Infants' Sleep: What do the Mothers Wish? What do the Fathers Think?
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.
Read the 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.
- Conditions
- Insomnia
- Keywords
- sleep, insomnia, children, actigraphy, marital relationship
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (7)
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.
Measured: Baseline
• 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.
Measured: Baseline
• 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.
Measured: baseline
• 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.
Measured: baseline
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.
Measured: Baseline
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.
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perran Boran, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092308
- Sponsor's protocol ID
- 09.2021.719
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Requests for wider sharing of data (for example in response to information on Marmara University webpages and in publications about the study and willingness to share), will be addressed on a case-by-case basis. Any data sharing request will be made to investigators through a pre-defined data requisition form. This form will contain information about the applicant, institution, purpose of data request, study objectives, ethical clearance of the study, etc. Once a request has been made the data governance body will discuss if that request was appropriate and meets the criteria set by the university; data will be released following signing of the data sharing agreement. The data will be stored on the Marmara University servers and not be deposited in any 'community' database.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perspectives of Parents About Their Infants' Sleep: What do the Mothers Wish? What do the Fathers Think?
- ClinicalTrials.gov ID
- NCT05092308
- Acronym / sponsor ID
- 09.2021.719
- Conditions
- Insomnia
- Keywords
- sleep, insomnia, children, actigraphy, marital relationship
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Age groups
- Child
- Study population
- - Parents and their 6-36 months old children with and without sleep problems
Key inclusion criteria (1 listed)
- Parents and their 6-36 months old children
Key exclusion criteria (3 listed)
- Divorced or separated couples
- Infants less than 37 weeks of gestational age
- Children with diagnosed developmental problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perspectives of parents on infant sleep
Time frame: Baseline
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.
7 secondary outcomes
Parental anxiety
Time frame: Baseline
• Parental depression symptoms
Time frame: Baseline
• Global relationship
Time frame: baseline
• Married-life satisfaction scale
Time frame: baseline
Parental Sleep quality
Time frame: Baseline
Infant sleep wake patterns
Time frame: Baseline
Infant sleep parameters
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: Undecided. Requests for wider sharing of data (for example in response to information on Marmara University webpages and in publications about the study and willingness to share), will be addressed on a case-by-case basis. Any data sharing request will be made to investigators through a pre-defined data requisition form. This form will contain information about the applicant, institution, purpose of data request, study objectives, ethical clearance of the study, etc. Once a request has been made the data governance body will discuss if that request was appropriate and meets the criteria set by the university; data will be released following signing of the data sharing agreement. The data will be stored on the Marmara University servers and not be deposited in any 'community' database.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Perran Boran (+905417127756, drperran@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perspectives of parents on infant sleep (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.