Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06471816

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Child Behavior Behavior Child Development

Age range

2 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eventus Barnehage AS, Bergen, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Gro J Wergeland, PhD

CONTACT

[email protected]

+47 481 76 828

Ingvar Bjelland, PhD

CONTACT

[email protected]

+47 909 55 893

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • University of Bergen
  • Western Norway University of Applied Sciences

Registry information

Official study title

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

Acronym: PRO-DIALOG

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 24, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.