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RecruitingNCT06471816PRO-DIALOGUpdated Oct 1, 2025

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

An interventional study of Dialogue Based Early Detection and Traditional parent-teacher meeting in Child Behavior and Child Development, sponsored by Haukeland University Hospital. Recruiting at 3 sites in Norway. Open to participants aged 2 Years to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-01.

Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2024, registered Jun 2024).
  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
2 Years to 3 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Child Behavior
  • Child Development

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Keywords

  • Health Promotion
  • Secondary Prevention
  • Kindergarten
  • Child Mental Health
  • Parent Involvement
03

In context

Child Behavior

224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.

This study's planned enrollment of 200 is above the median of 140 across 197 interventional studies indexed under Child Behavior.

Browse Child Behavior studies →

Lead sponsor

Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 3 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Parents don't communicate in Norwegian or English
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Intervention kindergartens

    Participants (parents of kindergarten children) will take part in the biannual DBED parent-teacher meetings.

    Other: Dialogue Based Early Detection

  • Active comparator
    Control kindergartens

    Participants (parents of kindergarten children) will take part in traditional parent-teacher meetings.

    Other: Traditional parent-teacher meeting

Interventions

  • OtherDialogue 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 interventions or further assessments locally in the kindergarten or in the public services will be decided.

  • OtherTraditional 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.

06

What researchers measure

Primary outcomes

  1. Total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)

    The SDQ has five scales (scored 0-10); emotional problems, conduct problems, hyperactivity, peer problems and pro-social scale. The scales are combined (excluding the pro-social scale) into a 'total difficulties' score (0-40).

    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

07

Study locations

3 of 3 sites recruiting
08

References and documents

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. PubMed 40842037 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06471816
Collaborators
University of Bergen, Western Norway University of Applied Sciences
Responsible party
Sponsor
First posted
Jun 24, 2024
Start date
Jan 1, 2024
Primary completion
Jun 30, 2029 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Oct 1, 2025

Study contacts

Ingvar Bjelland, PhD
Contact
ingvar.bjelland@helse-bergen.no
+47 909 55 893
Gro J Wergeland, PhD
Contact
gro.janne.henningsen.wergeland@helse-bergen.no
+47 481 76 828
Ingvar Bjelland, PhD
principal investigator · Haukeland University Hospital
Randi-Luise Møgster, MD
study director · Haukeland University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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