Children's WellbeingNCT05038280
Let´s Talk About Children Intervention in a School Context
A study testing Let's Talk about Children intervention in people with Children's Wellbeing and Child Overall Health Related Quality of Life, run by University of Helsinki at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Children's Wellbeing, Child Overall Health Related Quality of Life, Burnout
- What is being tested?
- Let's Talk about Children intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 27 Sep 2021to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- First-grade students
- Students' parents
- First-grade teachers
- Sufficient Finnish language skills
Who cannot join
- Insufficient Finnish language skills
Trial locations and contacts
1 site in 1 country.
Finland1 site
University of Helsinki: Faculty of Educational Sciences
Helsinki, 00014
About this study
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.
Read the 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?
- Being tested
- Let's Talk about Children intervention
- Keywords
- Let's Talk about Children, School, Teacher-Student Relationship, Teacher-Parent Relationship, Children's Wellbeing, Teachers' Occupational Wellbeing, Parental Burnout
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let's Talk about Children interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Let's Talk about Children intervention | Experimental | Teachers, students, and parents in Finland, that take part in the LTC -intervention. Receives: Behavioral: Let's Talk about Children intervention |
| Control group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in teacher and parent relationship
A set of teacher-parent interaction tests
Measured: 6 months after baseline
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.
Measured: 6 months after baseline
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.
Measured: 6 months after baseline
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.
Measured: 6 months after baseline
Secondary outcomes (3)
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.
Measured: 6 months after baseline
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.
Measured: 6 months after baseline
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).
Measured: 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start27 Sep 2021
- Primary completion31 Jan 2023
- Study completion31 May 2023
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 Children's WellbeingStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lotta Allemand, University of Helsinki
- Investigators
- Lotta Allemand, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038280
- Sponsor's protocol ID
- University of Helsinki
- Status last verified
- Nov 2023
- First submitted
- 24 Aug 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allemand L, Niemela M, Merikukka M, Salmela-Aro K. The "Let's Talk about Children" intervention in a Finnish school context: fidelity, parents' experiences, and perceived benefits. Front Psychol. 2023 Jun 9;14:1183704. doi: 10.3389/fpsyg.2023.1183704. eCollection 2023.
PubMed 37359866
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Let´s Talk About Children Intervention in a School Context
- ClinicalTrials.gov ID
- NCT05038280
- Acronym / sponsor ID
- University of Helsinki
- Keywords
- Let's Talk about Children, School, Teacher-Student Relationship, Teacher-Parent Relationship, Children's Wellbeing, Teachers' Occupational Wellbeing, Parental Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 9 Sep 2021 (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 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?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Let's Talk about Children intervention | Experimental | Behavioral: Let's Talk about Children interventionTeachers, students, and parents in Finland, that take part in the LTC -intervention. |
| Control group | No 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. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- First-grade students
- Students' parents
- First-grade teachers
- Sufficient Finnish language skills
Key exclusion criteria (1 listed)
- Insufficient Finnish language skills
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 |
|---|---|---|
| Let's Talk about Children interventionThe 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. | Behavioural | Let's Talk about Children intervention |
Primary outcome
Change in teacher and parent relationship
Time frame: 6 months after baseline
A set of teacher-parent interaction tests
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.
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.
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.
3 secondary outcomes
Change in teachers' occupational wellbeing: burnout
Time frame: 6 months after baseline
Change in teachers' occupational wellbeing: job engagement
Time frame: 6 months after baseline
Change in parents' wellbeing: burnout
Time frame: 6 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 37359866Allemand L, Niemela M, Merikukka M, Salmela-Aro K. The "Let's Talk about Children" intervention in a Finnish school context: fidelity, parents' experiences, and perceived benefits. Front Psychol. 2023 Jun 9;14:1183704. doi: 10.3389/fpsyg.2023.1183704. eCollection 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lotta Allemand principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let's Talk about Children intervention in people with Children's Wellbeing and Child Overall Health Related Quality of Life, run by University of Helsinki at 1 site in Finland.
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 4 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: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in teacher and parent relationship (time frame: 6 months after baseline). The study lists 4 primary outcomes in all. 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 NCT05038280, 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 29 Nov 2023.