Prevention of sleep problems in 0 - 2 year-old children Not Applicable
Conditions
Interventions
Current interventions as of 27/03/2024:
This study is a two-arm quasi-experimental trial that compares an intervention group with a care-as-usual control group. Regions have not been assigned randomly
Sponsors
Netherlands Organisation for Health Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 27/02/2024: 1. Adult, mentally competent mothers (or fathers/other primary caregivers) of healthy newborns. 2. The child is 0 to 10 weeks old. 3. The child has to be registered at a YHC centre in either the intervention group or the control group. Previous participant inclusion criteria: 1. Adult, mentally competent first-time mothers (or fathers/other primary caregivers of babies of first-time mothers) of healthy newborns. 2. The child is 0 to 10 weeks old. 3. The child has to be registered at the local YHC centre in one of the intervention regions or in the control region.
Exclusion criteria
Exclusion criteria: 1. The child is born prematurely (<37 weeks of pregnancy) 2. The child is diagnosed with a sleep disorder (such as pavor nocturnus, iactatio capitis, sleep walking, non-benign sleep myoclonic, obstructive sleep apnea, primary hypersomnia, circadian rhythm disorders, parasomnias, sleep related movement disorders) 3. The child is diagnosed with excessive crying 4. The child has a serious medical condition that impedes their sleep or wakefulness 5. The child receives medication that impacts their sleep or wakefulness (such as melatonin) 6. The child is part of a multiple birth 7. The parent(s) of the child do not speak Dutch 8. The parent receives care from the VoorZorg program: a special Youth Health Care program for vulnerable families.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality as measured by a sleep diary (total sleep duration, time to sleep onset, number and duration of night-time awakenings, bedtime regularity and sleeping problems) and the Infant Sleep and Parent Perception subscales of the Brief Infant Sleep Questionnaire at the child’s age of 10 weeks and 6, 9, 14 and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Parental management of infant sleep as measured with the ‘Parent Behaviour’ subscale items from the Brief Infant Sleep Questionnaire when their child is 10 weeks and 6, 9, 14 and 24 months old. 2. Parental self-efficacy in the management of infant sleep, as measured with the self-efficacy item from the Brief Infant Sleep Questionnaire when their child is 10 weeks and 6, 9, 14 and 24 months old. 3. Parental knowledge on the management of infant sleep, as measured with a questionnaire on parental sleep knowledge when the child is 10 weeks, 6 months and 14 months old. 4. Beliefs about the management of infant sleep, as measured with the limit-setting items from the ‘Maternal Cognitions about Infant Sleep Questionnaire’ when the child is 9 and 14 months old. 5. Satisfaction with YHC with respect to communication about the child’s sleep when the child is 6 and 24 months old. 6. Number of parents seeking help for the child’s sleep outside of YHC when the child is 9 and 24 months old. | — |
Countries
Netherlands
Outcome results
None listed