Viewing Study NCT06471816



Ignite Creation Date: 2024-07-17 @ 11:23 AM
Last Modification Date: 2024-10-26 @ 3:32 PM
Study NCT ID: NCT06471816
Status: RECRUITING
Last Update Posted: 2024-06-24
First Post: 2024-06-18

Brief Title: Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens
Sponsor: Haukeland University Hospital
Organization: Haukeland University Hospital

Study Overview

Official Title: Promoting Mental Health in Young Children - a Dialogue Based Approach in Kindergartens A Randomized Controlled Trial
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PRO-DIALOG
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 its 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 childs 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None