Clinical trial NCT04654533: Promoting Sensitivity in Center-based Childcare
Official title: SEnsitive Care: Understanding and REsponding - Promoting Sensitivity in Center-based Childcare of 0-2 Year Old Children (the SECURE Project)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caregiver Interactive Skills
Keywords: Quality of care in center-based early childcare
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Independent Research Fund Denmark
name: TrygFonden, Denmark
name: University of Groningen
name: The Danish Evaluation Institute
First posted: 2020-12-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized into intervention group or a waitlist
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the efficacy of an attachment research-informed intervention adapted to the Danish childcare context in terms of improving process quality in center-based childcare for 0-2 years old children. Specifically, the aim is to improve caregiver interactive skills and mind-mindedness. The intervention is delivered in groups during eight weekly sessions and is based on the manualized Circle of Security Parenting model, but adapted to the childcare context: The Circle of Security Classroom model. Intake is planned to be completed in January 2023 and 110 childcare providers are estimated to be enrolled in the trial.

Detailed description: Background:

It is well-established that children's early attachment relationship experiences with their primary caregivers play an important role in psycho-social development. However, it has been shown that also the child's relationship with other important caregivers, such as early professional caregivers in childcare, is important for socioemotional and academic development. In particular, if a child grows up in an at-risk context the quality of early childcare is pivotal for long-term development.

Children with an insecure attachment to their parents are at heightened risk for developing insecure attachments to professional caregivers. However, caregiver interactive skills are found to be associated with children's attachment security to professional caregivers, irrespective of the child's attachment relationship to the primary caregiver. Therefore, professional caregivers' ability to establish optimal interactions with the children in their care provides an important target of intervention in terms of promoting healthy child development.

In a randomized waitlist control trial, this study aims to

1. investigate the efficacy of COS-C in enhancing caregivers' interactive skills when interacting with groups of children in a natural busy real-life setting, their mind-mindedness (MM), and their work-specific resources to cope with stress.
2. investigate if changes in the caregivers' mind-mindedness is related to changes in their interactive skills.
3. explore if effects of the COS-C are moderated by personal and structural factors, here operationalized as the caregivers' own attachment style and staff stability.
4. evaluate the implementation of the COS-C by examining childcare providers' experience of the intervention's acceptability and feasibility, and we will examine the degree to acceptability and feasibility are related to the intervention's effectiveness. Investigating feasibility and acceptability of the COS-C intervention is essential in terms of evaluating the potential for up-scaling and further implementation of the intervention in Denmark
5. employing a qualitative approach we investigate a) how the caregivers and their managers make sense of changes caused by the intervention and b) how the caregivers experience the intervention in terms of its feasibility and acceptability when implemented in their daily practice.

Methods:

Childcare centers are recruited from a Danish municipality with a high proportion of at-risk families. Teams of 2-5 caregivers working in Danish childcare centers with children aged 0-2 years are allocated to either COS-C (eight weekly two-hour sessions) or a waitlist. A total of 110 caregivers are estimated to be enrolled, and the intervention will be delivered in groups of 6-10 caregivers. To facilitate implementation, the managers of the participating childcare providers are invited to participate in the intervention.

Effects of COS-C are measured using observations of video-recorded caregiver-child interaction (coded for six key interactive skills: Sensitive responsiveness, Respect for autonomy, structuring and limit setting, Verbal communication, Developmental stimulation, and Fostering positive peer interactions) and Mind-Mindedness (representational and interactional Mind-Mindedness) is measured via coding of transcribed interviews and video-recorded caregiver-child interactions. Structural and caregiver attachment style are measured using observation and questionnaires answered by caregivers and managers. Feasibility and acceptability of the intervention are evaluated using questionnaires and via qualitative interviews.

Perspectives:

The project will provide new knowledge on whether a relatively cost-effective intervention can improve the quality of care in Danish childcare centers for young children. Also, findings on how structural factors influence the quality of care will directly inform practice.

Eligibility criteria: Inclusion Criteria:

Childcare providers who work in Danish childcare centers ("dagtilbud") for children aged 0 - 60 months in the Municipality of Høje-Taastrup can participate in the study.

Childcare providers with an educational background within childcare as well as childcare providers without education within childcare are included.

Exclusion Criteria:

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Primary outcomes:
measure: Caregiver Interactive Profile (CIP-scales), Sensitive responsiveness scale.
timeFrame: 12-16 weeks
Secondary outcomes:
measure: The Mind-Mindedness Interview
timeFrame: 12-16 weeks
measure: Interactional Mind-Mindedness
timeFrame: 12-16 weeks
measure: Caregiver Interactive Profile (CIP-scales), Respect for autonomy, Structuring and limit setting, Verbal communication, Developmental stimulation, and Fostering positive peer interactions.
timeFrame: 12-16 weeks
measure: The Child Care Worker Job Stress Inventory
timeFrame: 12-16 weeks
Other outcomes:
measure: The Acceptability of Intervention Measure (AIM)
timeFrame: 12-16 weeks
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Up to 16 weeks
measure: Client Change Interview.
timeFrame: Up to 16 weeks
Locations:
city: Copenhagen
country: Denmark
facility: Department of Psychology, University of Copenhagen
Study officials:
References:
citation: Smith-Nielsen J, Wendelboe KI, Mohr JEW, Vaever MS, Pontoppidan M, Helmerhorst K, Egmose I. Promoting interactive skills and mind-mindedness among early childcare professionals: study protocol for a randomized wait-list controlled trial comparing the Circle of Security approach with care as usual in center-based childcare (the SECURE project). BMC Psychol. 2022 Jun 18;10(1):153. doi: 10.1186/s40359-022-00835-3.