Norwegian Tuning in to Kids Effectivity Study (N-TIK)

The current Randomised Controlled Trial study delivers and evaluate an evidence-based prevention program from Australia (Tuning in to Kids: TIK) to parent of preschool children. Reports from parents and preschool teachers are used to determine whether the program leads to universal benefits of improved wellbeing and reduced mental health difficulties for children and parents.

Study Overview

• Status: Active, not recruiting
• Conditions: Emotional Intelligence
• Intervention / Treatment: Behavioral: Tuning in to Kids

Detailed Description

The study recruits approximately 250 parents of preschool children through local kindergartens to evaluate the N-TIK program as a universal and selective prevention program. The study will use a cluster randomized controlled design and comparing an intervention with a wait-list control sample. Baseline measurement (Time 1) are gathered from parents, children and teachers and include measurement of parenting, parent functioning, child emotion competence, child behavior and child kindergarten adjustment. Following baseline assessment families is allocated into Intervention or Wait-list conditions. Intervention parents attend a 6-session group parenting program where they learn to emotion coach their children and regulate their own emotions. These groups are facilitated by selected research team facilitators. Post-program, Intervention parents complete program evaluation measures (Time 2) to provide program feedback. At 12-month follow-up (Time 3) baseline assessments are repeated for Intervention and Wait-list participants with preschool teachers reporting on children's adjustment. Wait-list parents are then offered the N-TIK program delivered by community practitioners who have been trained by the project team in the intervention and have previously co-facilitated groups alongside the research group facilitators. This ensures the program can be used beyond just the research study building sustainability of the preventive intervention in the municipalities

• Study Type: Interventional
• Enrollment (Actual): 431
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0358
    • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parent of a preschool child aged 4-5 years old

Exclusion Criteria:

• Under the age of 18
• Not able to read and write in Norwegian

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tuning in to Kids parenting program; Intervention groups receive the Tuning in to Kids parenting program	Behavioral: Tuning in to Kids; A parenting program that includes 6 group supervisions of parents, where emotion coaching and promotion of kids emotional competence are main focus.
No Intervention: Business as usual; control groups have "business as usual", and then get offered the intervention program after one year follow-up assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Emotion Socialization Questionnaire (PESQ)	Parent Emotion Socialization Questionnaire (PESQ) is a scale with items that are scored from 1 to 5, where 5 indicates high levels of specific parenting beliefs (i.e. emotion coaching and emotion dismissive beliefs). Change in PESQ from baseline to post intervention (up to 6 months after baseline) to 1 year follow-up measured by questionnaire reports.	Up to 18 months
Coping with children negative emotions scale (CCNES)	Coping with children negative emotions scale (CCNES) is a scale with items that are scored from 1 to 7, where 7 indicates high levels of specific parenting behavior (i.e. supportive and nonsupportive parenting behavior). Change in CCNES from baseline to post intervention (up to 6 months after baseline) to 1 year follow-up measured by questionnaire reports.	Uo to 18 months
Eysenck's child behavior questionnaire (ECBI)	Eysenck's child behavior questionnaire (ECBI) is a scale with items that are scored from 1 to 7, where 7 indicates high levels of behavior problems. Change in ECBI from baseline to post intervention (up to 6 months after baseline) to 1 year follow-up measured by questionnaire reports.	Up to 18 months
Preschool anxiety scale - revised (PAS-R)	Preschool anxiety scale - revised (PAS-R) is a scale with items that are scored from 1 to 5, where higher score indicates higher levels of anxiety. Change in PAS-R from baseline to post intervention (up to 6 months after baseline) to 1 year follow-up measured by questionnaire reports.	Up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Affect Integration Inventory (AII)	Affect Integration Inventory (AII) is a scale with scores from 0 to 8, where 8 indicates high affect integration. Change in AII from baseline to post intervention (up to 6 months after baseline) to 1 year follow-up measured by questionnaire reports.	Up to 18 months
Difficulties with Emotion Regulation Scale (DERS)	Difficulties with Emotion Regulation Scale (DERS) is a scale with scores from 1 to 5, where 5 indicates more difficulties with emotion regulation. Change in DERS from baseline to post intervention (up to 6 months after baseline) to 1 year follow-up measured by questionnaire reports.	Up to 18 months

Collaborators and Investigators

• Sponsor: University of Oslo
• Investigators: Principal Investigator: Evalill Bølstad, PhD, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Anticipated): December 31, 2027
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: intervention; Tuning in to Kids; emotion socialization
• Other Study ID Numbers: 002 (University of CT Health Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No