- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05038280
Let´s Talk About Children Intervention in a School Context
Study Overview
Status
Intervention / Treatment
Detailed Description
The Let´s Talk about Children Intervention method is one of the Effective Child & Family Methods. The LTC -method was developed as a part of the Functioning Child & Family project co-ordinated by the Finnish Institute for Health and Welfare. The LTC -intervention includes two steps: Let´s Talk about Children discussion and Let´s Talk about Children network meeting. The method is used in social- and healthcare services, kindergartens and schools but has been studied mainly in the field of social- and healthcare services. The aim of the LTC -work in schools is to support the child's well-being, learning and development in everyday life. The other aim of the LTC -intervention in the school environment is to support teachers and parents in their everyday interactions and activities with children. The LTC is used to build a common comprehensive understanding of the child and his/her situation in school and at home, and to plan actions based on this understanding. The aim is also to build a mutually supportive parent-teacher relationship based on respect. Students, parents and a teacher take part in the discussion. The LTC logbook is used as the framework for the discussions. The LTC -method is based on an ecological, transactional model of child development.
The research questions of the research study are:
Is the intervention delivered as designed? How do teachers/parents experience the Let´s Talk about Children intervention? Does the Let´s Talk about Children intervention have an effect on teacher and student relationship? Does the Let´s Talk about Children intervention have an effect on teacher and parent relationship? Does the Let´s Talk about Children intervention have an effect on students´ well-being? Does the Let´s Talk about Children intervention have an effect on teachers´ well-being at work? Does the Let´s Talk about Children intervention have an effect on parents´ well-being?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland, 00014
- University of Helsinki: Faculty of Educational Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- First-grade students
- Students' parents
- First-grade teachers
- Sufficient Finnish language skills
Exclusion Criteria:
- Insufficient Finnish language skills
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Let's Talk about Children intervention
Teachers, students, and parents in Finland, that take part in the LTC -intervention.
|
The LTC -intervention includes two steps: Let´s Talk about Children discussion and Let´s Talk about Children network meeting.
Students, students´ parents, and a teacher take part in the LTC -discussion.
The LTC logbook is used as the framework for the discussions.
The LTC discussion depicts the child's ordinary day in all developmental contexts and an action plan is made with parents to enhance the identified strengths and to give support in vulnerabilities.
When the action plan is difficult to carry out without further participants, the LTC-Network meeting is planned with parents (and sometimes also the child).
LTC-Network meeting provides a forum for case-based cross-sectoral collaboration, including also the families and their social network.
|
|
No Intervention: Control group
The control group includes teachers who do not use the method in their work and students and parents who do not participate in the discussions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in teacher and parent relationship
Time Frame: 6 months after baseline
|
A set of teacher-parent interaction tests
|
6 months after baseline
|
|
Change in children's wellbeing: psychiatric symptoms
Time Frame: 6 months after baseline
|
SDQ - The Strengths and Difficulties Questionnaires.
The SDQ has 25 items and consists of sub-scales to measure emotional symptoms, conduct problems, hyperactivity/inattention, peer problems and prosocial behavior.
Scoring 0-40 (prosocial scale is not included in the total score), higher score meaning more problems.
|
6 months after baseline
|
|
Change in children's wellbeing: health-related quality of life
Time Frame: 6 months after baseline
|
The Kid-KINDL-R.
The KINDL questionnaire is a generic instrument for assessing Health-Related Quality of Life in children and adolescents aged 3-17.
The KINDLR questionnaire consists of 24 Likert-scaled items associated with six dimensions: physical well-being, emotional well-being, self-esteem, family, friends and everyday functioning (school or nursery school/kindergarten).
The sub-scales of these six dimensions can be combined to produce a total score.
The total score is transformed to a scale of 0-100 such that higher score represents a better outcome, i.e. better HRQoL.
|
6 months after baseline
|
|
Change in teacher and student relationship
Time Frame: 6 months after baseline
|
Student-Teacher Relationship Scale (short form).
The STRS is a teacher-report instrument designed for teachers of children between the ages of 3 and 12 which measures a teacher's perception of conflict, closeness, and dependency with a specific child.
Teachers will complete the Student-Teacher Relationship Scale (short form) for each child in his/her classroom to assess Student-Teacher closeness and Student-Teacher conflict.
Seven items make up the Closeness subscale, 8 items make up the Conflict subscale.
Teachers respond to each item on a five-point scale (1 = definitely does not apply to 5 = definitely applies), with higher scores indicating a better outcome for the closeness scale and a worse outcome for the conflict scale.
|
6 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in teachers' occupational wellbeing: burnout
Time Frame: 6 months after baseline
|
Bergen Burnout Indicator 15.
The Bergen Burnout Inventory is comprised of 15 items, ranging from 1 to 5. The total score range is from 15 to 75 with a higher score reflecting higher burnout.
|
6 months after baseline
|
|
Change in teachers' occupational wellbeing: job engagement
Time Frame: 6 months after baseline
|
The Utrecht Work Engagement scale.
The UWES is comprised of 9 items, ranging from 1 to 5. The total score range is from 9 to 45 with a higher score indicating more work engagement.
|
6 months after baseline
|
|
Change in parents' wellbeing: burnout
Time Frame: 6 months after baseline
|
Parental Burnout Assessment (Finnish version of the PBA).
The scale consists of 23 items.
Nine measure exhaustion in one's parental role, six measure contrast with the previous parental self, five measure feelings of being fed up as a parent and three measure emotional distancing from one's children.
All item are rated on a 7-point Likert scale (0 = never; 6 = daily).
|
6 months after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lotta Allemand, University of Helsinki
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- University of Helsinki
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Burnout
-
Shengjing HospitalActive, not recruitingCareer Burnout | Student BurnoutChina
-
Fundacion Arturo Lopez PerezNot yet recruitingBurnout Syndrome | Professional Burnout
-
Wroclaw University of Health and Sport SciencesUniversity of Silesia in Katowice; Jan Dlugosz University in CzestochowaCompleted
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingOccupational Burnout
-
Region SkaneLund University; Swedish Council for Working Life and Social Research; County...CompletedProfessional BurnoutSweden
-
University of PadovaUniversity of ChileCompleted
-
University Hospital, Basel, SwitzerlandCompleted
-
Uppsala UniversityNot yet recruitingBurnout | Exhaustion Disorder | Clinical Burnout
-
Firstbeat Technologies OyTampere University; University of Jyvaskyla; Aisti Health OyActive, not recruitingOccupational Stress | Occupational BurnoutFinland
-
University Diego PortalesInstituto de Seguridad del Trabajo, ChileActive, not recruitingBurnout | Burnout, Caregiver | Parental BurnoutChile
Clinical Trials on Let's Talk about Children intervention
-
Oregon Center for Applied Science, Inc.CompletedSexually Transmitted Diseases | Communication | Adolescent Pregnancy | Sexuality | ParentalUnited States
-
University of GuelphCanadian Institutes of Health Research (CIHR); Western University; Society of...Completed
-
JHSPH Center for Clinical TrialsNational Cancer Institute (NCI)Enrolling by invitationCancer | Mobile Application | Social Support (Formal and Informal)United States
-
UNC Lineberger Comprehensive Cancer CenterNational Institutes of Health (NIH); National Human Genome Research Institute...Not yet recruiting
-
Nantes University HospitalNational Cancer Institute, France; Nantes University hospital, Research DepartmentNot yet recruiting
-
Centre for Evidence and Implementation Singapore...MOH Office for Healthcare Transformation (MOHT), SingaporeActive, not recruiting
-
University of WashingtonNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment (MCI) | Dementia, MildUnited States
-
Public Health Management CorporationDepartment of Health and Human ServicesCompletedPregnancy in AdolescenceUnited States
-
University of ChicagoChildrens Services Council; St. Marys Medical Center; Soma Medical Center; Home...Withdrawn
-
Child TrendsUniversity of California, San Francisco; Power to DecideRecruiting