NCT04654533

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 19, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

November 26, 2020

Last Update Submit

January 13, 2022

Conditions

Keywords

Quality of care in center-based early childcare

Outcome Measures

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

    12-16 weeks

Secondary Outcomes (4)

  • The Mind-Mindedness Interview

    12-16 weeks

  • Interactional Mind-Mindedness

    12-16 weeks

  • Caregiver Interactive Profile (CIP-scales), Respect for autonomy, Structuring and limit setting, Verbal communication, Developmental stimulation, and Fostering positive peer interactions.

    12-16 weeks

  • The Child Care Worker Job Stress Inventory

    12-16 weeks

Other Outcomes (3)

  • The Acceptability of Intervention Measure (AIM)

    12-16 weeks

  • Feasibility of Intervention Measure (FIM)

    Up to 16 weeks

  • Client Change Interview.

    Up to 16 weeks

Study Arms (2)

COSC

EXPERIMENTAL

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

Control

NO INTERVENTION

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

COSCOTHER

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.

COSC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, University of Copenhagen

Copenhagen, 1353, Denmark

RECRUITING

Related Publications (1)

  • 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.

Central Study Contacts

Johanne Smith-Nielsen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomized into intervention group or a waitlist
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 26, 2020

First Posted

December 4, 2020

Study Start

March 19, 2021

Primary Completion

January 1, 2023

Study Completion

June 1, 2023

Last Updated

January 28, 2022

Record last verified: 2022-01

Locations