Child BehaviorPRO-DIALOGNCT06471816
Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens
A study testing Dialogue Based Early Detection and Traditional parent-teacher meeting in people with Child Behavior and Child Development, run by Haukeland University Hospital at 3 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior, Child Development
- What is being tested?
- Dialogue Based Early Detection and Traditional parent-teacher meeting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesNorway
- Study dates
- 1 Jan 2024to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attendance in kindergarten
- Inclusion during the first half-year of the third last year in kindergarten
Who cannot join
- Parents don't communicate in Norwegian or English
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway3 sites, 3 recruiting
- Recruiting
Haukeland University Hospital
Bergen, NO-5021
Hilde M Ersvær, +47 404 90 226, hilde.margrethe.ersver@helse-bergen.no
Ingvar Bjelland, PhD, +47 909 55 893, ingvar.bjelland@helse-bergen.no
- Recruiting
Eventus Barnehage AS
Bergen, NO-5237
Thomas Hopland, +47 959 92 323, hopland@eventusbarnehage.no
Remi Kaldhussæter, +47 918 73 025, remi@eventusbarnehage.no
- Recruiting
Øygarden municipality
Straume, NO-5354
Trond Heggestad, +47 917 15 563, trond.heggestad@oygarden.kommune.no
Kjersti S Sundal, +47 924 59 375, kjersti.sundal@oygarden.kommune.no
About this study
Official title: 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:
Read more
- 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
- Being tested
- Dialogue Based Early Detection, Traditional parent-teacher meeting
- Keywords
- Health Promotion, Secondary Prevention, Kindergarten, Child Mental Health, Parent Involvement
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialogue Based Early DetectionOther
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 meetingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention kindergartens | Experimental | Participants (parents of kindergarten children) will take part in the biannual DBED parent-teacher meetings. Receives: Other: Dialogue Based Early Detection |
| Control kindergartens | Active comparator | Participants (parents of kindergarten children) will take part in traditional parent-teacher meetings. Receives: Other: Traditional parent-teacher meeting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: [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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Kindergartens from three different organisations are involved. The kindergartens are randomized to the implementation or control condition within each organisation (block randomization).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Western Norway University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Ingvar Bjelland, PhD, Principal investigator, Haukeland University HospitalRandi-Luise Møgster, MD, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471816
- Sponsor's protocol ID
- 151749
- Acronym
- PRO-DIALOG
- Status last verified
- Sep 2025
- First submitted
- 18 Jun 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06471816
- Acronym / sponsor ID
- PRO-DIALOG / 151749
- Conditions
- Child Behavior, Child Development
- Keywords
- Health Promotion, Secondary Prevention, Kindergarten, Child Mental Health, Parent Involvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen, Western Norway University of Applied Sciences
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Kindergartens from three different organisations are involved. The kindergartens are randomized to the implementation or control condition within each organisation (block randomization).
| Arm | Type | Receives |
|---|---|---|
| Intervention kindergartens | Experimental | Other: Dialogue Based Early DetectionParticipants (parents of kindergarten children) will take part in the biannual DBED parent-teacher meetings. |
| Control kindergartens | Active comparator | Other: Traditional parent-teacher meetingParticipants (parents of kindergarten children) will take part in traditional parent-teacher meetings. |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Attendance in kindergarten
- Inclusion during the first half-year of the third last year in kindergarten
Key exclusion criteria (1 listed)
- Parents don't communicate in Norwegian or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialogue Based Early DetectionBefore 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. | Other | Intervention kindergartens |
| Traditional parent-teacher meetingThis 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. | Other | Control kindergartens |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 40842037Bjelland 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.
- Paper that describes the development of the intervention / method under study in PRO-DIALOGLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ingvar Bjelland, PhD principal investigator
Haukeland University Hospital
Randi-Luise Møgster, MD study director
Haukeland University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialogue Based Early Detection and Traditional parent-teacher meeting in people with Child Behavior and Child Development, run by Haukeland University Hospital at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingvar Bjelland, PhD (+47 909 55 893, ingvar.bjelland@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06471816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.