Caregiver Interactive SkillsSECURENCT04654533
Promoting Sensitivity in Center-based Childcare
A study testing COSC in people with Caregiver Interactive Skills, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Interactive Skills
- What is being tested?
- COSC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Mar 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Psychology, University of Copenhagen
Copenhagen, 1353
About this study
Official title: SEnsitive Care: Understanding and REsponding - Promoting Sensitivity in Center-based Childcare of 0-2 Year Old Children (the SECURE Project)
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
- 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.
- Conditions
- Caregiver Interactive Skills
- Being tested
- COSC
- Keywords
- Quality of care in center-based early childcare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12-16 weeks
Secondary outcomes (4)
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.
Measured: 12-16 weeks
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.
Measured: 12-16 weeks
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.
Measured: 12-16 weeks
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.
Measured: 12-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start19 Mar 2021
- Primary completionJan 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver Interactive SkillsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into intervention group or a waitlist
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Independent Research Fund Denmark, TrygFonden, Denmark, University of Groningen, The Danish Evaluation Institute
- Responsible party
- Principal investigator, Johanne Smith-Nielsen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654533
- Sponsor's protocol ID
- 514-0151/20-2000
- Acronym
- SECURE
- Status last verified
- Jan 2022
- First submitted
- 26 Nov 2020
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEnsitive Care: Understanding and REsponding - Promoting Sensitivity in Center-based Childcare of 0-2 Year Old Children (the SECURE Project)
- ClinicalTrials.gov ID
- NCT04654533
- Acronym / sponsor ID
- SECURE / 514-0151/20-2000
- Conditions
- Caregiver Interactive Skills
- Keywords
- Quality of care in center-based early childcare
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Independent Research Fund Denmark, TrygFonden, Denmark, University of Groningen, The Danish Evaluation Institute
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized into intervention group or a waitlist
| Arm | Type | Receives |
|---|---|---|
| COSC | Experimental | Other: COSCEight 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COSCCOSC 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. | Other | COSC |
Primary outcome
Caregiver Interactive Profile (CIP-scales), Sensitive responsiveness scale.
Time frame: 12-16 weeks
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
4 secondary outcomes
The Mind-Mindedness Interview
Time frame: 12-16 weeks
Interactional Mind-Mindedness
Time frame: 12-16 weeks
Caregiver Interactive Profile (CIP-scales), Respect for autonomy, Structuring and limit setting, Verbal communication, Developmental stimulation, and Fostering positive peer interactions.
Time frame: 12-16 weeks
The Child Care Worker Job Stress Inventory
Time frame: 12-16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Derived from this study: PubMed 35717243Smith-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COSC in people with Caregiver Interactive Skills, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanne Smith-Nielsen, PhD (+4523984303, johanne.smith@psy.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Interactive Profile (CIP-scales), Sensitive responsiveness scale. (time frame: 12-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04654533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.