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

November 2, 2022 updated by: Evalill Bølstad, PhD, University of Oslo
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
431

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parent Emotion Socialization Questionnaire (PESQ)
Time Frame: Up to 18 months
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)
Time Frame: Uo to 18 months
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)
Time Frame: Up to 18 months
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)
Time Frame: Up to 18 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Affect Integration Inventory (AII)
Time Frame: Up to 18 months
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)
Time Frame: Up to 18 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oslo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Evalill Bølstad, PhD, University of Oslo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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