Clinical trial NCT04651465: Norwegian Tuning in to Kids Effectivity Study
Official title: Norwegian Tuning in to Kids Effectivity Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Emotional Intelligence
Keywords: emotion socialization
intervention
Tuning in to Kids
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 431
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Parent Emotion Socialization Questionnaire (PESQ)
timeFrame: Up to 18 months
measure: Coping with children negative emotions scale (CCNES)
timeFrame: Uo to 18 months
measure: Eysenck's child behavior questionnaire (ECBI)
timeFrame: Up to 18 months
measure: Preschool anxiety scale - revised (PAS-R)
timeFrame: Up to 18 months
Secondary outcomes:
measure: Affect Integration Inventory (AII)
timeFrame: Up to 18 months
measure: Difficulties with Emotion Regulation Scale (DERS)
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Evalill Bølstad, PhD
role: PRINCIPAL_INVESTIGATOR
References: