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

NCT06471816 | Recruiting

• 1 other identifier: 151749
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Child Behavior; Child Development

Keywords

Health Promotion; Secondary Prevention; Kindergarten; Child Mental Health; Parent Involvement

Outcome Measures

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: 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

Study Arms (2)

Intervention kindergartens

EXPERIMENTAL

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

Other: Dialogue Based Early Detection

Control kindergartens

ACTIVE COMPARATOR

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

Other: Traditional parent-teacher meeting

Interventions

Dialogue Based Early Detection OTHER

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.

Intervention kindergartens

Traditional parent-teacher meeting OTHER

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.

Control kindergartens

Eligibility Criteria

• Age: 2 Years - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Attendance in kindergarten

You may not qualify if:

• Parents don't communicate in Norwegian or English

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator
• Western Norway University of Applied Sciences: collaborator

Study Sites (3)

Haukeland University Hospital

Bergen, NO-5021, Norway

RECRUITING

Eventus Barnehage AS

Bergen, NO-5237, Norway

RECRUITING

Øygarden municipality

Straume, NO-5354, Norway

RECRUITING

Related Publications (1)

• 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 DERIVED

Related Links

• Paper that describes the development of the intervention / method under study in PRO-DIALOG

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ingvar Bjelland, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Randi-Luise Møgster, MD

  Haukeland University Hospital

  STUDY DIRECTOR

Central Study Contacts

Ingvar Bjelland, PhD

CONTACT

+47 909 55 893; ingvar.bjelland@helse-bergen.no

Gro J Wergeland, PhD

CONTACT

+47 481 76 828; gro.janne.henningsen.wergeland@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Kindergartens from three different organisations are involved. The kindergartens are randomized to the implementation or control condition within each organisation (block randomization).

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

NO (3)