Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens (PRO-DIALOG)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Child Behavior; Child Development
• Intervention / Treatment: Other: Dialogue Based Early Detection; Other: Traditional parent-teacher meeting

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ingvar Bjelland, PhD; Phone Number: +47 909 55 893; Email: ingvar.bjelland@helse-bergen.no
• Study Contact Backup: Name: Gro J Wergeland, PhD; Phone Number: +47 481 76 828; Email: gro.janne.henningsen.wergeland@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, NO-5021
    • Recruiting
    • Haukeland University Hospital
    • Contact: Ingvar Bjelland, PhD; Phone Number: +47 909 55 893; Email: ingvar.bjelland@helse-bergen.no
    • Contact: Hilde M Ersvær; Phone Number: +47 404 90 226; Email: hilde.margrethe.ersver@helse-bergen.no
  • Bergen, Norway, NO-5237
    • Recruiting
    • Eventus Barnehage AS
    • Contact: Thomas Hopland; Phone Number: +47 959 92 323; Email: hopland@eventusbarnehage.no
    • Contact: Remi Kaldhussæter; Phone Number: +47 918 73 025; Email: remi@eventusbarnehage.no
  • Straume, Norway, NO-5354
    • Recruiting
    • Øygarden municipality
    • Contact: Trond Heggestad; Phone Number: +47 917 15 563; Email: trond.heggestad@oygarden.kommune.no
    • Contact: Kjersti S Sundal; Phone Number: +47 924 59 375; Email: kjersti.sundal@oygarden.kommune.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention kindergartens; Participants (parents of kindergarten children) will take part in the biannual DBED parent-teacher meetings.	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 interventions or further assessments locally in the kindergarten or in the public services will be decided.
Active Comparator: Control kindergartens; Participants (parents of kindergarten children) will take part in traditional parent-teacher meetings.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen; Western Norway University of Applied Sciences
• Investigators: Principal Investigator: Ingvar Bjelland, PhD, Haukeland University Hospital; Study Director: Randi-Luise Møgster, MD, Haukeland University Hospital

Publications and helpful links

General 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 22, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Health Promotion; Child Mental Health; Secondary Prevention; Kindergarten; Parent Involvement
• Additional Relevant MeSH Terms: Behavior; Child Behavior
• Other Study ID Numbers: 151749

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No