NCT05038280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

August 24, 2021

Last Update Submit

November 28, 2023

Conditions

Keywords

Let's Talk about ChildrenSchoolTeacher-Student RelationshipTeacher-Parent RelationshipChildren's WellbeingTeachers' Occupational WellbeingParental Burnout

Outcome Measures

Primary Outcomes (4)

  • Change in teacher and parent relationship

    A set of teacher-parent interaction tests

    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.

    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.

    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.

    6 months after baseline

Secondary Outcomes (3)

  • Change in teachers' occupational wellbeing: burnout

    6 months after baseline

  • Change in teachers' occupational wellbeing: job engagement

    6 months after baseline

  • Change in parents' wellbeing: burnout

    6 months after baseline

Study Arms (2)

Let's Talk about Children intervention

EXPERIMENTAL

Teachers, students, and parents in Finland, that take part in the LTC -intervention.

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.

Interventions

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.

Let's Talk about Children intervention

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • First-grade students
  • Students' parents
  • First-grade teachers
  • Sufficient Finnish language skills

You may not qualify if:

  • \- Insufficient Finnish language skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Helsinki: Faculty of Educational Sciences

Helsinki, 00014, Finland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Lotta Allemand

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2021

First Posted

September 9, 2021

Study Start

September 27, 2021

Primary Completion

January 31, 2023

Study Completion

May 31, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations