Clinical trial NCT06471816: Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens
Official title: Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Behavior
Child Development
Keywords: Health Promotion
Secondary Prevention
Kindergarten
Child Mental Health
Parent Involvement
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: Western Norway University of Applied Sciences
First posted: 2024-06-24
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Kindergartens from three different organisations are involved. The kindergartens are randomized to the implementation or control condition within each organisation (block randomization).
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if the novel Dialogue Based Early Detection (DBED) method can prevent impaired mental health in kindergarten children. It will also learn about the screening properties of DBED to identify children with impaired mental health, if DBED facilitates early interventions, and if DBED is well accepted and sustainable in an ordinary kindergarten setting.

The main questions it aims to answer are:

* Do children in kindergartens where DBED is implemented develop better mental health scores than children in kindergarten where DBED is not implemented?
* How well identifies DBED kindergarten children with impaired mental health compared to a traditional screening instrument (the Strengths and Difficulties Questionnaire)?
* What is the impact of DBED on activation of interventions for mental health problems?
* What is the social validity of DBED?

Researchers will compare outcomes in kindergartens where DBED is implemented with outcomes in kindergartens where it's not.

* During the last three years of kindergarten attendance participants (parents of kindergarten children) in the intervention kindergartens will take part in the biannual DBED parent-teacher meetings, while participants in the control kindergartens will take part in traditional parent-teacher meetings.
* Twice a year all participants will answer questionnaires of the child's mental health and parental stress during the follow-up period (3 years in kindergarten and 2 first years in school).
* Participants in the intervention kindergartens will answer user satisfaction questionnaires after every parent-teacher meeting.
* The kindergarten teachers will report on type and time of supportive interventions for each participating child during the follow-up period in kindergarten.


Eligibility criteria: Inclusion Criteria:

* Attendance in kindergarten
* Inclusion during the first half-year of the third last year in kindergarten

Exclusion Criteria:

* Parents don't communicate in Norwegian or English

Primary outcomes:
measure: Total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)
timeFrame: The SDQ is completed by both kindergarten teacher and each parent twice a year during the three last year of attendance of the child in kindergarten, continued by the parents during the first two years in school
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Bergen
country: Norway
facility: Eventus Barnehage AS
city: Straume
country: Norway
facility: Øygarden municipality
Study officials:
affiliation: Haukeland University Hospital
name: Ingvar Bjelland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haukeland University Hospital
name: Randi-Luise Møgster, MD
role: STUDY_DIRECTOR
References: