1. Compared to the control group, 4 weeks and 8 weeks after the start of centre-based care infants in the intervention group will show: - Lower morning and afternoon levels of salivary cortisol - Less disruption of the gut microbiota and an improved…
ID
Bron
Verkorte titel
Aandoening
Participants are healthy infants entering centre-based childcare
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Infant outcomes
1.1 Infants’ cortisol levels
Saliva will be collected at 10h and 16h on at least one day a week. From all infants present more than 1 day, saliva will be sampled twice a week.
1.2 Infants’ gut microbiota
Faecal samples will be taken from the infant’s diaper before the start of CBC, 4 weeks and 8 weeks after the start.
1.3. Infants’ mood, crying and sleeping behaviour at home in the night
Parents keep track of their infants’ sleep and crying at home with an adapted version of the “Parental diary of infant cry and fuss behaviour” (Barr et al., 1988), starting 2 weeks prior to centre-based care until 8 weeks after the start. Parents will fill in the diary daily from 18h until 8 hours the next morning. The diary also includes questions on the infant's mood, care arrangements, health, feeding type, and the use of an infant carrier.
Childcare professionals' outcomes
2.1. Childcare professionals’ cortisol levels
The childcare professional who works most hours a week with the infant will provide a salivary samples on the same days as the infant, at 10h in the morning and 16h in the afternoon.
2.2. Childcare professionals’ mood
All participating childcare professionals of the infant's group will fill in the adapted 3-item scale on affect after the 16h saliva sampling moments. (Vigor and affect scale; Monk, 1989). An additional question addresses the infant’s mood perceived by the childcare professional on that day.
2.2. Childcare professionals’ subjective experience
Qualitative questions on the childcare professionals’ experience with the study, the infant and work in the period of the last 4 weeks; filled in by all childcare professionals of the group after week 4 and week 8.
Parental outcomes
3.1.Parents’ subjective mood
Parents will fill in a shortened version of the “Global vigor and affect scale” (Monk, 1989) daily starting two weeks prior to the start of centre-based care until 8 weeks after the start.
Achtergrond van het onderzoek
Physical proximity and closeness are crucial for young infants and have been related to decreased cortisol concentrations. At centre-based care (CBC), Dutch childcare professionals have a ratio of 3:1 with infants, and cannot always provide them with optimal attention and closeness. Accordingly, a previous study found increased cortisol concentrations in 3-month-olds during the first weeks at CBC, suggesting that the transition can be stressful. In this project, we will investigate the effectiveness of a stress-reducing intervention during this transition. In a randomised controlled trial, infants are assigned to a care-as-usual (CAU) or an intervention condition. In the intervention condition, they receive additional closeness and attention by a “buddy” throughout the first four weeks at CBC. In both groups, we will monitor stress-related measures, such as cortisol, gut microbiota and behavioural reports. In both groups, behavioural data will be collected starting two weeks before the intervention, during the four weeks of intervention, and for another four weeks after the intervention. Cortisol and gut microbiota will be monitored from the first week at CBC until 8 weeks after the start. We will also assess the effects of the intervention on parents’ and childcare professionals’ subjective well-being and childcare professionals’ cortisol levels. Altogether, this study might lay foundations for a supportsystem that benefits both the infant and the caregivers.
Doel van het onderzoek
1. Compared to the control group, 4 weeks and 8 weeks after the start of centre-based care infants in the intervention group will show:
- Lower morning and afternoon levels of salivary cortisol
- Less disruption of the gut microbiota and an improved diversity
- Decreased crying and fussing at night and a better mood at nights and in
centre-based care
- Increased nightly sleep and less nightly awakenings
2. Childcare staff of the intervention group will show:
- Improved subjective well-being
- Decreased morning and afternoon levels of salivary cortisol
- Childcare staff in the intervention group will report less job related stress
after the intervention.
3. Parents of infants in the intervention group will show improved subjective well-being, when compared to infants of the control group.
Potential underlying mechanisms:
Infant temperament, parental upbringing, care of the first months (noise of the home environment and prior care arrangements), and the amount of contact with the buddy mediates the relation of the intervention and infant outcomes.
Onderzoeksopzet
Data collection will take place two weeks before the infants’ entrance at centre-based care and last until 8 weeks after entrance.
Week -2: Two weeks before the start of centre-based care. Parents and childcare-staff will fill in questionnaires.
Week 1-4: At centre-based care. A buddy will be present for infants in the intervention group
Week 1-8: A faecal sample will be collected in week 1, 4 and 8. Saliva from infants and one childcare staff will be collected once/twice a week (depending on how many days the infant visits centre-based care) at centre-based care at 10 am and 16 pm. Parents fill in the nightly diary on crying and fussing. Parents and childcare staff regularly fill in a short screening on well-being.
Week 8: Childcare staff and parents will fill in questionnaires on their experiences with the project.
Onderzoeksproduct en/of interventie
Intervention
Trained researchers and assistants will be the buddy of infants in the intervention group. Throughout the first four weeks, the buddy will be present in the intervention group from 9.30 am to 16 pm, on every day the infant visits centre-based care. Every infant in the intervention group will have one buddy who is not exchanged throughout the study. Only on occasions when the infant’s buddy is not available (e.g. sick), another researcher/assistant can replace the buddy.
Role of the Buddy
Buddies will assist the childcare professionals, providing the infants with closeness and attention during their adaptation to childcare. The buddy will support the infant and, for instance, hold the infant, gently rock the infant, talk and sing, and soothe the infant when needed. The buddy will hold the infant for at least 2 hours a day. In case the infant starts crying, the buddy will pick him/her up for soothing. In case the infant cries in the buddy’s arm unsoothably for a longer time, the childcare professional will take over. When brought to bed, if the infant cries in the crib for longer than 2 minutes, or is fussy for longer than 10 minutes, the buddy will try to soothe the infant and pick him/her up if necessary. The buddy can also feed the infant. One bottle a day will always be fed by the childcare professional. The buddy will not take over other caregiving tasks, such as diaper changes. The childcare professional will still be responsible for monitoring the infants’ needs and recognising when caregiving tasks are necessary. All buddies will acquire a “Verklaring omtrent gedrag” and be registered in the “personenregister kinderopvang”. To ensure consistency across infants, all buddies will be female.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Infants participating in this study will be included if they:
o are between 1 and 5 months old at entrance to centre-based care.
o arrive at centre-based care no later than 10 am and stay there at least until 4 pm on at least one day a week.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from
participation:
o Infants of parents younger than 18 years old
o Infants of parents not fluent in Dutch (since many questionnaires are only available in Dutch)
o Infants with severe congenital anomalies
o Infants with severe health issues
o Infants born before gestational week 37
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL9276 |
Ander register | CMO region Arnhem-Nijmegen : 2020-7230 |