Menu
Recruiting NCT06471816

Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens

No phase Interventional Child Behavior Child Development

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dialogue Based Early Detection, Traditional parent-teacher meeting.
Who it may be relevant to
Registry conditions: Child Behavior, Child Development. Basic parameters: 2 years — 3 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens: A Randomized Controlled Trial

Overview

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.

Interventions

  • Other Dialogue Based Early Detection
    Before the biannual parent-teacher meeting, both the kindergarten teacher and the parents will complete the Early Worry Questionnaire containing 39 items related to development and well-being of the individual child. For each item the respondents are asked to indicate if they during the last three months have been concerned. In the parent-teacher meeting they will discuss their possible concerns and try to reach an agreement on how to evaluate the child. If necessary, possible supportive interve
  • Other Traditional parent-teacher meeting
    This is an annual or biannual meeting that is prepared by the kindergarten teacher where (s)he reports on the child's appearance / behaviour and possible challenges as to development and behaviour from an educationalist's view. There are no common templates for the agenda of such meetings, however, usually the kindergarten teacher's perspective and opinion will dominate.

Primary outcome measures

  • Total difficulties score of the Strengths and Difficulties Questionnaire (SDQ) [Time frame: [Time Frame: The SDQ is completed by both kindergarten teacher and each parent twice a year with approximately 6 months intervals during the three last year of attendance of the child in kindergarten, continued by the parents during the first two years i]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Norway · 3 centers
  • Haukeland University Hospital — Bergen
  • Eventus Barnehage AS — Bergen
  • Øygarden municipality — Straume

Publications

  • Bjelland I, Wergeland GJ, Gillberg C, Gjestad R, Visnjic-Jevtic A, Lisaeth VK, Miniscalco C, Tufta ALF, Vermeer IL, Sadownik AR, Wilson P, Posserud MB. PRO-DIALOG-the effect of a novel dialogue-based parent-teacher conference on mental health in kindergarten children: a cluster randomized controlled trial. Trials. 2025 Aug 21;26(1):299. doi: 10.1186/s13063-025-08980-x. PMID 40842037

Identifiers

NCT: NCT06471816 · 151749

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗