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Promoting Sensitivity in Center-based Childcare (SECURE)

Primary Purpose

Caregiver Interactive Skills

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
COSC
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caregiver Interactive Skills focused on measuring Quality of care in center-based early childcare

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Department of Psychology, University of CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

COSC

Control

Arm Description

Eight weekly manualized sessions of Circle of Security Classroom (COSC), delivered in groups, two hours per session, 5-10 childcare providers per group. COSC is facilitated by a psychologist who is a registered COSP facilitator and who has completed the an additional COSC online training.

Usual care control condition, i.e., standard practice in the participating childcare centers. Teams of childcare providers are allocated to either COSC or waitlist in clusters, and baseline and follow-up measures are collected parallel in both groups. Childcare providers allocated to the waitlist will receive COSC after the follow-up data have been collected.

Outcomes

Primary Outcome Measures

Caregiver Interactive Profile (CIP-scales), Sensitive responsiveness scale.
Coding of sensitive responsiveness is based on video-recorded caregiver-child interactions and sensitivity is rated on a 7-point scale with higher ratings reflecting higher levels of sensitivity

Secondary Outcome Measures

The Mind-Mindedness Interview
Representational Mind-Mindedness is based on coding of a transcribed brief interview. Each attribute that refers to the child is classified into four categories: 1) Mental attributes, 2) Behavioral attributes, 3) Physical attributes, 4) General attributes, 5) Self-referential comments and 6) Comments regarding institutional practices. The index of representational MM is the total number of mental attributes with higher scores reflecting more Mind-Mindedness.
Interactional Mind-Mindedness
Coding of interactional Mind-Mindedness is based on observation of video-recorded caregiver-child interaction. Each recording is transcribed verbatim. The transcript is used to identify all mind-related comments that are coded dichotomously as appropriate versus non-attuned by observing the recorded interaction. The two indexes of interactional Mind-Mindedness are: 1) total number of appropriate comments, mind-related, and 2) non-attuned, mind-related comments, with higher scores of appropriate comments reflecting more optimal mind-mindedness and higher scores of non-attuned comments reflecting less optimal mind-mindedness.
Caregiver Interactive Profile (CIP-scales), Respect for autonomy, Structuring and limit setting, Verbal communication, Developmental stimulation, and Fostering positive peer interactions.
Coding of each interactive skill is based on observation of video-recorded caregiver-child interaction and is rated on a 7-point scale with higher ratings reflecting more optimal interaction.
The Child Care Worker Job Stress Inventory
The Job resources sub scale is used. 17 questions that are rated on a 5-point likert scale from 1: rarely/never to 5: most of the time.

Full Information

First Posted
November 26, 2020
Last Updated
January 13, 2022
Sponsor
University of Copenhagen
Collaborators
Independent Research Fund Denmark, TrygFonden, Denmark, University of Groningen, The Danish Evaluation Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04654533
Brief Title
Promoting Sensitivity in Center-based Childcare
Acronym
SECURE
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Independent Research Fund Denmark, TrygFonden, Denmark, University of Groningen, The Danish Evaluation Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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. investigate if changes in the caregivers' mind-mindedness is related to changes in their interactive skills. 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. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Interactive Skills
Keywords
Quality of care in center-based early childcare

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized into intervention group or a waitlist
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COSC
Arm Type
Experimental
Arm Description
Eight weekly manualized sessions of Circle of Security Classroom (COSC), delivered in groups, two hours per session, 5-10 childcare providers per group. COSC is facilitated by a psychologist who is a registered COSP facilitator and who has completed the an additional COSC online training.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care control condition, i.e., standard practice in the participating childcare centers. Teams of childcare providers are allocated to either COSC or waitlist in clusters, and baseline and follow-up measures are collected parallel in both groups. Childcare providers allocated to the waitlist will receive COSC after the follow-up data have been collected.
Intervention Type
Other
Intervention Name(s)
COSC
Intervention Description
COSC is professional development program for early childcare providers adapted from the Circle of Security-Parenting (COSP) model. It is a manualized intervention that leverages research on attachment relationships combining psycho-education with a mentalization-based approach. The model uses pre-produced video vignettes of secure and problematic caregiver-child interactions to illustrate how caregivers' may struggle in meeting children's' attachment needs. Participants are invited to reflect on how they meet and perhaps still not meet the needs of the children in their care with a particular focus on the challenging or 'difficult' children. The COSP manual has been translated into Danish (Cooper, Hoffman and Powel, 2020, translated by Pedersen, Kronendorf von Wowern, Lier, & Smith-Nielsen), and the additional COSC material has been translated into Danish for the purpose of this study.
Primary Outcome Measure Information:
Title
Caregiver Interactive Profile (CIP-scales), Sensitive responsiveness scale.
Description
Coding of sensitive responsiveness is based on video-recorded caregiver-child interactions and sensitivity is rated on a 7-point scale with higher ratings reflecting higher levels of sensitivity
Time Frame
12-16 weeks
Secondary Outcome Measure Information:
Title
The Mind-Mindedness Interview
Description
Representational Mind-Mindedness is based on coding of a transcribed brief interview. Each attribute that refers to the child is classified into four categories: 1) Mental attributes, 2) Behavioral attributes, 3) Physical attributes, 4) General attributes, 5) Self-referential comments and 6) Comments regarding institutional practices. The index of representational MM is the total number of mental attributes with higher scores reflecting more Mind-Mindedness.
Time Frame
12-16 weeks
Title
Interactional Mind-Mindedness
Description
Coding of interactional Mind-Mindedness is based on observation of video-recorded caregiver-child interaction. Each recording is transcribed verbatim. The transcript is used to identify all mind-related comments that are coded dichotomously as appropriate versus non-attuned by observing the recorded interaction. The two indexes of interactional Mind-Mindedness are: 1) total number of appropriate comments, mind-related, and 2) non-attuned, mind-related comments, with higher scores of appropriate comments reflecting more optimal mind-mindedness and higher scores of non-attuned comments reflecting less optimal mind-mindedness.
Time Frame
12-16 weeks
Title
Caregiver Interactive Profile (CIP-scales), Respect for autonomy, Structuring and limit setting, Verbal communication, Developmental stimulation, and Fostering positive peer interactions.
Description
Coding of each interactive skill is based on observation of video-recorded caregiver-child interaction and is rated on a 7-point scale with higher ratings reflecting more optimal interaction.
Time Frame
12-16 weeks
Title
The Child Care Worker Job Stress Inventory
Description
The Job resources sub scale is used. 17 questions that are rated on a 5-point likert scale from 1: rarely/never to 5: most of the time.
Time Frame
12-16 weeks
Other Pre-specified Outcome Measures:
Title
The Acceptability of Intervention Measure (AIM)
Description
3 questions that are rated on a 5-point likert scale ranging from Completely disagree to Completely agree
Time Frame
12-16 weeks
Title
Feasibility of Intervention Measure (FIM)
Description
4 questions that are rated on a 5-point likert scale ranging from Completely disagree to Completely agree.
Time Frame
Up to 16 weeks
Title
Client Change Interview.
Description
A semi-structured qualitative interview aiming to help clients express (as freely as possible) how they experience a psychotherapeutic intervention has worked. The interview guide has been adjusted to fit the childcare context and the specific intervention for the purpose of this study.
Time Frame
Up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johanne Smith-Nielsen, PhD
Phone
+4523984303
Email
johanne.smith@psy.ku.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Katrine Wendelboe, MSc
Phone
+459350 9184
Email
katrine.isabella.wendelboe@psy.ku.dk
Facility Information:
Facility Name
Department of Psychology, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
1353
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
35717243
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.
Results Reference
derived

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Promoting Sensitivity in Center-based Childcare

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