Let´s Talk About Children Intervention in a School Context
Primary Purpose
Children's Wellbeing, Child Overall Health Related Quality of Life, Burnout
Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Let's Talk about Children intervention
Sponsored by
About this trial
This is an interventional prevention trial for Children's Wellbeing focused on measuring Let's Talk about Children, School, Teacher-Student Relationship, Teacher-Parent Relationship, Children's Wellbeing, Teachers' Occupational Wellbeing, Parental Burnout
Eligibility Criteria
Inclusion Criteria:
- First-grade students
- Students' parents
- First-grade teachers
- Sufficient Finnish language skills
Exclusion Criteria:
- Insufficient Finnish language skills
Sites / Locations
- University of Helsinki: Faculty of Educational Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Let's Talk about Children intervention
Control group
Arm Description
Teachers, students, and parents in Finland, that take part in the LTC -intervention.
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.
Outcomes
Primary Outcome Measures
Change in teacher and parent relationship
A set of teacher-parent interaction tests
Change in children's wellbeing: psychiatric symptoms
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.
Change in children's wellbeing: health-related quality of life
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.
Change in teacher and student relationship
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.
Secondary Outcome Measures
Change in teachers' occupational wellbeing: burnout
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.
Change in teachers' occupational wellbeing: job engagement
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.
Change in parents' wellbeing: burnout
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).
Full Information
NCT ID
NCT05038280
First Posted
August 24, 2021
Last Updated
November 1, 2022
Sponsor
University of Helsinki
1. Study Identification
Unique Protocol Identification Number
NCT05038280
Brief Title
Let´s Talk About Children Intervention in a School Context
Official Title
Let´s Talk About Children Intervention in a School Context
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to examine the fidelity, the perceived benefits, and the effectiveness of the Let's Talk about Children (LTC) -intervention in a school context. The Let's Talk about Children method is a standardised, family-focused intervention aimed to build a shared understanding between parents, children, and teachers to find ways of working together to support the child's everyday life, well-being, learning, and development, both at home and at school. The Let's Talk about Children intervention is used in several different schools in Finland. The study examines the effects of the Let's Talk about Children method on the teacher-student relationship, the trust between teachers and parents and the students', teachers' and parents' well-being. Participants (N=1316 school-children, N=188 school-teachers and N=1316 parents) are recruited and divided into intervention and control groups. The intervention group consists of teachers who use the Let's Talk about Children method in their work and those students and parents who participate in the Let's Talk about Children discussions. 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. The fidelity and perceived benefits of the method are examined in the intervention group. Otherwise, there is two data collection points. The data is collected in intervention and control groups before the intervention and 6 months after the intervention.
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children's Wellbeing, Child Overall Health Related Quality of Life, Burnout
Keywords
Let's Talk about Children, School, Teacher-Student Relationship, Teacher-Parent Relationship, Children's Wellbeing, Teachers' Occupational Wellbeing, Parental Burnout
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2820 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Let's Talk about Children intervention
Arm Type
Experimental
Arm Description
Teachers, students, and parents in Finland, that take part in the LTC -intervention.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Let's Talk about Children intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in teacher and parent relationship
Description
A set of teacher-parent interaction tests
Time Frame
6 months after baseline
Title
Change in children's wellbeing: psychiatric symptoms
Description
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.
Time Frame
6 months after baseline
Title
Change in children's wellbeing: health-related quality of life
Description
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.
Time Frame
6 months after baseline
Title
Change in teacher and student relationship
Description
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.
Time Frame
6 months after baseline
Secondary Outcome Measure Information:
Title
Change in teachers' occupational wellbeing: burnout
Description
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.
Time Frame
6 months after baseline
Title
Change in teachers' occupational wellbeing: job engagement
Description
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.
Time Frame
6 months after baseline
Title
Change in parents' wellbeing: burnout
Description
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).
Time Frame
6 months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
First-grade students
Students' parents
First-grade teachers
Sufficient Finnish language skills
Exclusion Criteria:
- Insufficient Finnish language skills
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lotta Allemand
Organizational Affiliation
University of Helsinki
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Helsinki: Faculty of Educational Sciences
City
Helsinki
ZIP/Postal Code
00014
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
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Let´s Talk About Children Intervention in a School Context
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