- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06501300
Tuning in to Kids in School - Competence Building and Collaboration in the Team Around Primary School Students (TIKiS)
The current project is a randomized controlled trial of the Australian evidence-based parenting program Tuning in to Kids® which has been adapted for using with Norwegian elementary school teachers (Tuning in to Kids in Schools; TIKiS).
TIKiS aims to improve emotion socialization practices of primary school teachers so that children's emotional competence is promoted.
This project will determine effectiveness and implementation quality of TIKiS through questionnaire and observation measures given before and after the intervention, comparing intervention and wait-list control schools.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project is a collaboration between the University of Oslo, the education agency and health agency in Oslo municipality, Norway.
A total of 20 schools will be recruited for the project, and randomly allocated to the intervention or wait-list control condition (10 in each). Teachers in the intervention schools will receive the TIKiS intervention delivered by trained facilitators. Facilitators of the teacher groups will be from staff from education and health agencies and will have at least a masters' degree in psychology, pedagogy or similar.
The TIKiS program facilitators attend a two day training in TIKiS. In addition, they will attend a 90-minute workshop and receive three days of 90-minute program supervision before they act as program facilitators for the teachers.
In the intervention condition, school leaders will attend adapted three 90-minute group sessions to assist with implementation. All teachers in the intervention schools will attend introduction sessions outlining the program. Then teachers and other relevant school staff (special education teachers, resource teachers, social teachers and assistants) in grade 1-4 (the first 4 years of elementary school) will attend six x 90 minute group sessions led by a pair of program facilitators.
In intervention and control schools, facilitators of groups, teachers and relevant school staff will complete questionnaires at baseline and follow-up. Observations of classes of these teachers and staff will be conducted at baseline and follow-up.
Control schools will receive the intervention following completion of all follow-up measures.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0373
- Department of Psychology, University of Oslo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- School staff that work with children in grades 1.-4.
Exclusion Criteria:
- (Exclusion from analysis) school staff in the intervention school that did not participate in the intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Teachers and relevant school staff six 90-minute supervised group lessons with a 1-2 week space between each time. School leaders attend three 90-minute sessions adapted to them |
The aim of the TIKiS is to improve emotion coaching and reduce emotion dismissing in elementary school teachers through six x 90-minute group sessions.
|
|
No Intervention: Waitlist Control
Receives no intervention, business as usual.
Receives intervention the following year.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Classroom Assessment Scoring system - CLASS- K3
Time Frame: Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
A structured, validated observation measure of a classroom's social-emotional environment.
Scored from 1 to 7 where 1 is low score (few behaviour markers observed or are rarely observed) and 7 is a high score (many behaviour indicators are frequently observed).
(Pianta, La Paro, & Hamre, 2008).
|
Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
|
Coping with Children's Negative Emotions Teacher Version - CCNES-T:
Time Frame: Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
A measure of emotion coaching and emotion dismissing behaviors (Fabes et al., 2000). This study uses a short form of the original CCNES (21 questions), which has been modified and translated to Norwegian. Teachers rate how likely they are to respond to childrens' expressions of negative emotions in various scenarios on a scale of 1 (very unlikely) to 7 (very likely). |
Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
|
Program differentiation
Time Frame: Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
Program differentiation is how differnt our intervention is from similar interventions that the school has used recently.
This is measured by asing teachers to what degree they have worked with similar teaching strategies in the previous year on a scale of 1 (not at all) to 5 (a lot).
|
Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
|
Content Fidelity/Adherance
Time Frame: Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
Content Fidelity/Adherance is is how much of the manual and planned content that the facilitators cover for each group session.
Facilitators fill in a checklist of core components after each group session to get the proportion of core content completed for each session and in total for the whole intervention.
|
Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
|
Dosage
Time Frame: Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
Dosage is how much of the intervention each participant received, which will be measured as the proportion of intervention sessions that each teacher participated in.
|
Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
|
Reach
Time Frame: Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
Reach is measured as the proportion of eligible teachers that have participated in the intervention, and the proportion of eligible schools that have participated.
|
Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
|
Teacher Implementation
Time Frame: 5 months after intervention (post-intervention)
|
Teacher feedback on program satisfaction and use of program content will be measured quantitively trhough a questionnaire and qualitatively and through focus group interviews. The questionnaire will ask about obstacles and ease of attending the intervention and using the learned content afterwards, and what aspects they found useful on a scale of 1 to 7 where 1 is a low score and 7 is a high score. The questionnaire will also ask about what cocepts they have used, and what stopped them from attending using multiple choice with a free text option. The focus group interviews will be used to get a more detailed assessment of program satisfaction and use of program content |
5 months after intervention (post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Affect Integration Inventory (AII)
Time Frame: Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
A measure of how well various emotions are integrated (Solbakken & Monsen, 2017).
Teachers rate how well 18 statements about emotions describe them from a scale of 0 (doesnt fit at all) to 9 (fits perfectly).
|
Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
|
Bergen burnout inventory (BBI)
Time Frame: Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
A measure of employee burnout with 9 items. Participants rate how nmuch they agree with each of the 9 statemetns from 1 (disagree completely ) to 6 (agree completely). (Matthiesen, 1992; Salmela-Aro et al., 2011) |
Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
|
Hopkins symptom checklist 10 - HSCL-10
Time Frame: Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
A measure of distress, which consists of two subscales; anxiety and depression (Derogatis et al., 1974; Hesbacher et al., 1980; Strand et al., 2003).
This is a short form of the HSCL with only 10 questions (6 depression, 4 anxiety).
Particiapnts rate how much they have experienced each of the 10 symptoms in the past week form 1 (not at all) to 4 (a lot).
|
Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
|
Satisfaction with Life scale (SWLS)
Time Frame: Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
A 5 item scale that measures satisfaction with life (Diener et al., 1985).
Participatns rate how much they agree with each of the 5 statements on a scale of 1 (fits poorly) to 7 (fits perfectly).
|
Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
|
Collaboration between school health service, educational psychological services and teachers in Oslo.
Time Frame: Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
Likert scale from 1 to 5 of how well the employees experience the collaboration with the other services.
Where 1 is they disagree completely that there is a good collaboration and 5 is they agree completely that there is a good colaboration.
|
Right before intervention (Baseline) and 5 months after intervention (post-intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sophie Havighurst, University of Oslo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Other Study ID Numbers
- TIKiS Norway
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.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
Atisama TherapeuticsRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on Emotion-focused: Tuning in to Kids in School
-
University of OsloActive, not recruitingParent and Child Emotional Intelligence and Child Self-regulationNorway
-
Children's Hospital Medical Center, CincinnatiCompletedHeart Defects, Congenital | Parenting | Emotion RegulationUnited States
-
University of OsloActive, not recruiting
-
Lusofona UniversityFundação para a Ciência e a Tecnologia; FUNDAÇAO CALOUSTE GULBENKIAN; Santa Casa... and other collaboratorsRecruitingParental Emotion Socialization | Parents' Beliefs About and Reactions to Children's Emotions | Parental Emotion RegulationPortugal
-
The University of Hong KongCompletedADHD | Emotion Regulation | Parenting InterventionHong Kong
-
University of OsloCompleted
-
University Hospital, AkershusUniversity of Oslo; University of Melbourne; ExtrastiftelsenTerminated
-
St. Jude Children's Research HospitalNational Heart, Lung, and Blood Institute (NHLBI)RecruitingSickle Cell DiseaseUnited States
-
Oregon Social Learning CenterU.S. Department of EducationCompletedSchool ReadinessUnited States
-
Oregon Social Learning CenterNational Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute...Completed