- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03985124
Tuning in to Kids in Norwegian FUS Kindergartens (TIK-FUS)
A Randomized Controlled Trial of Tuning in to Kids in Norwegian FUS Kindergartens
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research questions will be does Tuning in to Kids (TIK) for teachers:
- lead to improved teacher meta-emotion philosophy (beliefs about emotions), teacher emotion awareness/regulation and wellbeing?
- lead to improved teacher emotion socialisation (decreased emotion dismissiveness and increased emotion coaching) and emotional responsiveness?
- lead to improvements in the kindergarten social and emotional climate and improved organisational functioning of the kindergarten?
- lead to improved child emotion vocabulary and social, emotional, behavioural functioning?
- provide a cost-effective method for improving the functioning of the FUS kindergartens?
TIK for Teachers will aim to alter the teacher and kindergarten functioning which in turn is expected to impact children's emotional competence (emotion vocabulary/regulation) thereby impacting wider aspects of child functioning (behaviour, social functioning). In this trial of Tuning in to Kids in Norwegian FUS kindergartens, a cluster randomised design will be used. Forty-eight kindergartens, (consisting of 880 teachers), will be randomised into intervention or 12-month wait-list control. All kindergartens (intervention and control) will complete measures at baseline and 10-month follow-up (in August 2019 and then June 2020). Once baseline measures have been collected from all kindergartens (intervention and control), those in the intervention condition will receive the TIK intervention (October through to March). Twelve-month follow up measures will be collected in June 2020 and will be the same measures collected at baseline (outlined below) as well as data on intervention implementation (attendance dosage, feasibility, acceptability). Control kindergartens will receive the same measures at the same times as the intervention kindergartens and will receive the intervention after the 12-month waiting period (in autumn 2020).
Tuning in to Kids for Teachers - TIK-T: Intervention
This intervention is professional training for teachers/childcare workers. Key components include:
- Kindergarten leaders/principals and all school workers will receive an initial three hour briefing on the intervention in March 2019;
- Kindergarten leaders/lead pedagogue will attend a two-day (14 hours) professional training in TIK to learn to use emotion coaching with children in December 2019. This will give them skills to support teachers in their application of the ideas in their interactions with children.
- Childcare workers/kindergarten teachers will attend a full day training (seven hours) in how to use emotion coaching and in skills to understand and regulate their emotions January 2020;
- The Kindergarten leaders/education or pedagogue will deliver supervision sessions to assist teachers in implementation of the TIK ideas. This will be two x three hour sessions at monthly intervals (February, March 2020);
- Structured manuals will be used for intervention delivery and fidelity checklists to ensure adherence to the intervention.
- Support materials will be provided in online format/manuals for all teachers.
Measures:
- a structured, validated observation measure of classroom social-emotional environment;
- teacher responses on questionnaires about their meta-emotion philosophy (beliefs about emotions), emotion awareness/regulation, emotion socialisation (emotion dismissiveness and emotion coaching), emotion wellbeing/mental health and perceptions of the functioning of the kindergarten/school;
- kindergarten leader's responses on questionnaires about the kindergarten environment;
- kindergarten organisational data on teacher absences, staff turnover etc to measure overall organisational functioning;
- parents will complete an online questionnaire about their child's emotional language, social/emotional/behavioural functioning and their experience of support/engagement with the kindergarten. The will also complete a brief measure on their emotion socialization.
- a small number of children (for whom parental consent is given) in eight kindergartens will participate in a direct assessment at the kindergarten of the child's emotion knowledge;
- costs of intervention delivery along with expected financial costs/benefits of (improved) organisational functioning (such as costs of staff absences, re-hiring, organisational problems)
- Intervention implementation: information will be collected from teachers/kindergarten leaders about intervention acceptability, feasibility and dosage/attendance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bergen, Norway
- FUS Kindergartens
-
Oslo, Norway
- FUS Kindergartens
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Trondheim, Norway
- FUS Kindergartens
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- teachers/kindergarten workers in the eligible kindergartens
- all children
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention TIK-T
24 kindergartens will receive the full intervention.
Dosage: 1 3 hour implementation session for kindergarten leaders; 1 x 2-day training workshop for kindergarten leaders and a lead resource person in each kindergarten who will support teachers in learning and implementing Emotion Coaching with children; 2 full training days for all teachers/childcare workers in Emotion Coaching; 2 x booster sessions for all teachers with the resource person in their kindergarten to assist them in using Emotion Coaching with children in their kindergartens.
|
This is an emotion-focused intervention for teachers giving them skills in emotion coaching children in their care and also understanding and managing their own emotions.
|
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No Intervention: wait list control
24 kindergartens will be in the 12-month wait list condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Coping with Toddler's Negative Emotions Scale (CTNES)
Time Frame: Baseline and 10 month follow up
|
Teacher's responsiveness to children's emotions using the CTNES (12 scenarios, 6 possible responses for each)
|
Baseline and 10 month follow up
|
|
Change in Classroom Assessment Scoring System (CLASS)
Time Frame: Baseline and 10 month follow up
|
The CLASS" is an observational tool for assessing classroom quality in the kindergarten based on teacher - child interactions in the classroom rather than evaluation of the physical environment or a specific curriculum.
Divided into 3 domains: emotional support (positive climate, negative climate, teacher sensitivity, and regard for student perspectives), classroom organization (behavior management, productivity, and instructional learning formats), and instructional support (concept development, quality of feedback, and language modeling).
These constructs are rated on a 7-point scale (1-2 low, 3-5 mid, and 6-7 high) recorded in 30-minutes (20 min observation, 10 min scoring) cycles over a period of up to 3 hours (with six as the recommended average number of observation cycles).
|
Baseline and 10 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change on Brief Problem Monitor (BPM)
Time Frame: Baseline and 10 month follow up
|
Parent reports on children's behavioural functioning using the BPM, an 18-item parent-reported questionnaire.
Items are rated on a 0, 1, 0r 2 scale, with one being absence and 2 being strongly indicated.
|
Baseline and 10 month follow up
|
|
Change on Emotion Regulation Checklist,
Time Frame: Baseline and 10 month follow up
|
Parent report on child emotion regulation; a 24 item parent reported questionnaire that gives subscales of emotion regulation and lability/negativity.
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Baseline and 10 month follow up
|
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Change on EAS Temperament Scale
Time Frame: Baseline and 10 month follow up
|
Parent report on child emotionality using a 20 item measure that gives subscales of Reactivity, Sociability, Shyness and Activity
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Baseline and 10 month follow up
|
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Change on Emotional literacy - parent reported
Time Frame: Baseline and 10 month follow up
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Parent report emotion language using a list of 60 emotion words where parents indicate whether or not the child would understand the given word.
|
Baseline and 10 month follow up
|
|
Change on Emotional literacy - direct assessment
Time Frame: Baseline and 10 month follow up
|
Using an iPad, and 60 different emotion words, testers will ask the child to point to one of 4 pictures to see if they can identify emotion words.
|
Baseline and 10 month follow up
|
|
Change on Parent perception of kindergarten environment
Time Frame: Baseline and 10 month follow up
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Questions about perceived emotional support child receives in kindergarten.
These will be set questions asking parents to rate on a 1 - 5 point likert scale their satisfaction, support etc from the kindergarten.
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Baseline and 10 month follow up
|
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Change on Teacher perception of kindergarten environment
Time Frame: Baseline and 10 month follow up
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Questions about perceived support teacher received in workplace.
These will be set questions asking teachers to rate on a 1 - 5 point likert scale their satisfaction, support perceived functioning of the kindergarten.
|
Baseline and 10 month follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Evalill B Karevold, PhD, University of Oslo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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