NCT04651465

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
431

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Feb 2017Dec 2027

Study Start

First participant enrolled

February 7, 2017

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

10.9 years

First QC Date

November 13, 2020

Last Update Submit

November 2, 2022

Conditions

Keywords

emotion socializationinterventionTuning in to Kids

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Affect Integration Inventory (AII)

    Up to 18 months

  • Difficulties with Emotion Regulation Scale (DERS)

    Up to 18 months

Study Arms (2)

Tuning in to Kids parenting program

EXPERIMENTAL

Intervention groups receive the Tuning in to Kids parenting program

Behavioral: Tuning in to Kids

Business as usual

NO INTERVENTION

control groups have "business as usual", and then get offered the intervention program after one year follow-up assessment.

Interventions

A parenting program that includes 6 group supervisions of parents, where emotion coaching and promotion of kids emotional competence are main focus.

Tuning in to Kids parenting program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, 0358, Norway

Location

Study Officials

  • Evalill Bølstad, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised control trial, where both intervention and control group participants are assessed at baseline, and then the intervention groups get the intervention, and all group participants are assessed at follow up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 13, 2020

First Posted

December 3, 2020

Study Start

February 7, 2017

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations