Contact-based Intervention for Infants during Transition to Centre-based Care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28625

Enrollment

Registered

2021-02-16

Start date

2021-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants are healthy infants entering centre-based childcare

Interventions

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 a

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Infant outcomes 1.1Infants’ 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. 1.2Infants’ 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.	—

Measure

Time frame

Infant outcomes 1.1Infants’ 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. 1.2Infants’ 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.

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Secondary

Measure	Time frame
Infant - Demographics and health: Parents will fill in questionnaires on demographics of their infant such as infant age, number of siblings, and questions on the infant’s health. - Temperament, assessed with the Infant Behaviour Questionnaire-Revised Short Form before the start of CBC and the Very Short Form after week 4 and week 8 of centre-based care (Putnam et al., 2014). - The buddy will keep track of the infant's sleeping- and crying behaviour, as well as the amount of holding and bottles she provides, by filling in a logbook, based on the Parental cry- and fuss diary (Barr et al., 1988). Centre-based care - Group characteristics: In the Netherlands, the groups in childcare are either vertical or horizontal. Vertical groups consist of children from the age of zero to four and in horizontal groups, children are divided by age, whereby infants go to “baby-groups”. In vertical groups, the care-taker child ratio is lower than in horizontal groups. Infants of both of the group styles can participate in the study. We will take this difference, as well as caretaker-child ratio, into account as moderators. - Child care worker job stress inventory (translated; Curbow et al., 2000): The professionals of the infants' group will fill this in after week 4. - Childcare professionals demographics (ie. education, work experience, number of own children) - Childcare professionals' subjective experience with the infants' transition and the buddy intervention Parental factors/Care in the first months Parents fill in the following questionnaires at the beginning of the study: “Parental Ethnotheories Scale” (Lamm and Keller, 2007), “Maternal Responsiveness Questionnaire” (Leerkes and Qu, 2016), Maternal Separation Anxiety Scale” (Hock et al., 1989), Questions on feeding type, sleeping arrangements (room-sharing/bed-sharing/own room), whether they use a baby carrier, care arrangements, noise of the home environment, demographics (ie. marital status, living arrangements, SES, w	—

Measure

Time frame

Infant - Demographics and health: Parents will fill in questionnaires on demographics of their infant such as infant age, number of siblings, and questions on the infant’s health. - Temperament, assessed with the Infant Behaviour Questionnaire-Revised Short Form before the start of CBC and the Very Short Form after week 4 and week 8 of centre-based care (Putnam et al., 2014). - The buddy will keep track of the infant's sleeping- and crying behaviour, as well as the amount of holding and bottles she provides, by filling in a logbook, based on the Parental cry- and fuss diary (Barr et al., 1988). Centre-based care - Group characteristics: In the Netherlands, the groups in childcare are either vertical or horizontal. Vertical groups consist of children from the age of zero to four and in horizontal groups, children are divided by age, whereby infants go to “baby-groups”. In vertical groups, the care-taker child ratio is lower than in horizontal groups. Infants of both of the group styles can participate in the study. We will take this difference, as well as caretaker-child ratio, into account as moderators. - Child care worker job stress inventory (translated; Curbow et al., 2000): The professionals of the infants' group will fill this in after week 4. - Childcare professionals demographics (ie. education, work experience, number of own children) - Childcare professionals' subjective experience with the infants' transition and the buddy intervention Parental factors/Care in the first months Parents fill in the following questionnaires at the beginning of the study: “Parental Ethnotheories Scale” (Lamm and Keller, 2007), “Maternal Responsiveness Questionnaire” (Leerkes and Qu, 2016), Maternal Separation Anxiety Scale” (Hock et al., 1989), Questions on feeding type, sleeping arrangements (room-sharing/bed-sharing/own room), whether they use a baby carrier, care arrangements, noise of the home environment, demographics (ie. marital status, living arrangements, SES, w

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Contacts

Public ContactNicole Rheinheimer

Radboudumc

nicole.rheinheimer@radboudumc.nl004915730973605

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)