ClinicalTrials.gg
Status unknownNCT04654533SECUREUpdated Jan 28, 2022

Promoting Sensitivity in Center-based Childcare

An interventional study of COSC in Caregiver Interactive Skills, sponsored by University of Copenhagen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-28.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Caregiver Interactive Skills

Keywords

  • Quality of care in center-based early childcare
03

In context

Lead sponsor

University of Copenhagen is the lead sponsor of 465 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    COSC

    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.

    Other: COSC

  • No intervention
    Control

    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.

Interventions

  • OtherCOSC

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12-16 weeks

Secondary outcomes

  1. 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.

    Time frame: 12-16 weeks

  2. 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.

    Time frame: 12-16 weeks

  3. 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.

    Time frame: 12-16 weeks

  4. 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.

    Time frame: 12-16 weeks

Other outcomes

  1. The Acceptability of Intervention Measure (AIM)

    3 questions that are rated on a 5-point likert scale ranging from Completely disagree to Completely agree

    Time frame: 12-16 weeks

  2. Feasibility of Intervention Measure (FIM)

    4 questions that are rated on a 5-point likert scale ranging from Completely disagree to Completely agree.

    Time frame: Up to 16 weeks

  3. Client Change Interview.

    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

07

Study locations

1 of 1 sites recruiting
  • Department of Psychology, University of Copenhagen
    Copenhagen, 1353, Denmark
    Recruiting
08

References and documents

Publications

  • 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. PubMed 35717243 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2021 (actual). Primary completion is estimated for Jan 2023, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2020
First posted
Dec 4, 2020
StartActual
Mar 19, 2021
Primary completionEst.
Jan 2023
CompletionEst.
Jun 2023
Last update
Jan 28, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04654533
Collaborators
Independent Research Fund Denmark, TrygFonden, Denmark, University of Groningen, The Danish Evaluation Institute
Responsible party
Johanne Smith-Nielsen (Associate Professor, University of Copenhagen) — Principal investigator
First posted
Dec 4, 2020
Start date
Mar 19, 2021
Primary completion
Jan 2023 (estimated)
Completion
Jun 2023 (estimated)
Last update
Jan 28, 2022

Study contacts

Johanne Smith-Nielsen, PhD
Contact
johanne.smith@psy.ku.dk
+4523984303
Katrine Wendelboe, MSc
Contact
katrine.isabella.wendelboe@psy.ku.dk
+459350 9184

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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