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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04651465
Other study ID # 002
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 7, 2017
Est. completion date December 31, 2027

Study information

Verified date November 2022
Source University of Oslo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 431
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Norway University of Oslo Oslo

Sponsors (1)

Lead Sponsor Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
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