Condition category
Mental and Behavioural Disorders
Date applied
17/03/2017
Date assigned
28/03/2017
Last edited
27/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Special education students with learning disabilities are known to be at risk for developing emotional and behavioural problems. This can threaten students' school readiness and complicate teaching, requiring punishment which may lead to dropping out of school. In contrast, emotional problems are often underestimated and are likely to remain unaddressed. Unfortunately, solely using punishment strategies to deal with problem behaviour seems to be ineffective and only makes the problems worse. Previous research shows that programmes such as the School-Wide Positive Behaviour Support (SWPBS) can be effective at preventing and addressing external problems (i.e. behavioural issues). However, SWPBS lacks clear evidence-based interventions for dealing with negative emotions and internalizing problems (i.e. emotional problems). Therefore, the TIME-IN programme was developed as a school-wide healthcare policy, which extends SWPBS by also adding emotional support systems such as Emotion Regulation Training (ERT). TIME-IN aims to improve the inclusion of special education students with learning disabilities in the classroom by teaching adaptive emotion regulation strategies and by reducing externalised and internalised problems, which is also a key priority for Flemish government as part of recent educational reformation. The aim of this study is to test the effectiveness of the TIME-IN programme on children’s emotion regulation, behaviour and emotional well-being in special education children.

Who can participate?
Children aged 8-12 with learning disabilities, their parents and their special education teachers.

What does the study involve?
Participating schools are allocated to either receiving the TIME-IN programme or to continue as normal. Schools receive the programme if they display that they are willing and ready to implement it. TIME-IN is supervised by a school psychologist and follows a three level approach using proactive (creating or controlling a situation), preventive (preventing a situation) and curative (curing a situation) programmes. TIME-IN works to create a school wide plan to create a safe school environment and to determine student’s special educational needs. The programme also includes training on classroom management, promoting emotional awareness, coaching emotional regulating strategies (i.e. problem-solving) and repairing conflicts between teachers and children. Schools who do not receive the TIME-IN programme continue with their normal care. Emotional regulation strategies and school readiness of students are measured before and after the programme using questionnaires for teachers, students and their parents.

What are the possible benefits and risks of participating?
A possible benefit with participating is that the programme may improve children's school readiness and prevent school drop-out. There are no notable risks with participating.

Where is the study run from?
MPI 't Craeneveld Oudenaarde (Belgium)

When is the study starting and how long is it expected to run for?
September 2015 to June 2015

Who is funding the study?
1. Educational Government (Belgium)
2. Special Research Fund Ghent University (BOF) University of Ghent (Belgium)

Who is the main contact?
Mr Henk Weymeis
Henk.Weymeis@Ugent.be

Trial website

http://www.time-in.be (website) https://www.acco.be/nl-be/items/9789462922884/Wij-zijn-gedrag (protocol)

Contact information

Type

Scientific

Primary contact

Mr Henk Weymeis

ORCID ID

http://orcid.org/0000-0001-8887-8376

Contact details

University of Ghent
Henri Dunantlaan 2
Gent
9000
Belgium
+32 485 652 678
henk.weymeis@ugent.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ISBN 978-94-6292-288-4

Study information

Scientific title

Extending school-wide positive behaviour support (swpbs) with emotional support systems in promoting school readiness: Effect of time-in on special education children's externalizing and internalizing problems

Acronym

TIME-IN

Study hypothesis

1. TIME-IN improves special education children's adaptive emotion regulation strategies compared to a control group with no intervention
2. TIME-IN reduces both children's externalizing and internalizing problems compared to a control group with no intervention
3. TIME-IN reduces both children's externalizing and internalizing problems through adaptive emotion regulation

Ethics approval

Ethical Commission of Ghent University Faculty of Psychology and Pedagogical Sciences, 22/9/2014, ref: 2014/45

Study design

Prospective controlled two armed non randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Children with learning disabilities, at risk for developing behavioural, emotional and academic problems (clinical sample).

Intervention

Participating schools are allocated to either receiving the intervention or to the control group. Schools are allocated based on their readiness to implement the intervention programme and based on the implementation criteria such as sufficient awareness of need and motivation to get started with the implementation of a demanding school-wide programme. This is done through discussions with school boards. Control schools are chosen randomly selected from an ongoing study on school readiness in 18 nearby schools.

Intervention group (TIME-IN):
Participating schools implement the TIME-IN programme over nine months. This consists of 48 meetings, lasting a total of 122 hours. Five workshops of three hours and one two-hour plenary information sessions is devoted to the development and presentation of a school-wide charter and additionally three three-hour discussion sessions are held over the year to evaluate the schools action plan. Next, one plenary information session (three hours) is organised to discussion children's screening results and six workshops of three hours on the implementation of a school-wide quality assurance system is implemented: Action-Oriented Working in the Classroom (AOW). 30 teachers are trained about the programme through five three-hour workshops. The school clinical psychologist staff receive four workshops (three hours) to training outside classroom interventions. Finally two school-parent contacts (three hours) are organised to involve parents in the learning process.

Teachers are expected to enhance a safe classroom climate by formulating and visualizing positive behavioural expectations, practicing relational skills and providing clear instructions regarding the course content. Teachers promote emotional competencies using classroom emotional thermometers tools which enhance emotion identification by visualising different emotions and fostering emotional understanding. Students' special needs and adaptive emotion regulation strategies are improved by using a student reminder card. When aggressive behaviour or an emotional crisis arise, staff use the Life Space Crisis Intervention procedure in order to repair the conflictual relationship between teachers and child. Teachers support the children to cool down and receive assistance from the school psychologist.

Control group (Care as usual):
The control group does not receive any interventions and continue with their normal care.

School readiness is measured at baseline and at month nine (after the intervention) using questionnaires for teachers, students and their parents in a multi-informant assessment procedure.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Externalizing problems are measured using the Teacher Report Form (TRF) at baseline and nine months
2. Internalizing problems are measured using the Teacher Report Form (TRF) at baseline and nine months
3. Depressive symptoms are measured using the Child Depression Inventory (CDI) at baseline and nine months

Secondary outcome measures

Emotional regulation strategies are measured using FEEL-KJ is measured using at baseline and nine months

Overall trial start date

20/05/2014

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Special Education Children with learning disabilities between 8 - 12 years old
2. Their biological parents (father and/or mother)
3. Their Special Education Teacher

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

T0: 100 participants T1: 100 participants

Participant exclusion criteria

1. Children, parents or teachers who do not consent to participate in the study
2. Children younger than 8 and older than 12 years
3. Children who are not primarily diagnosed with a learning disability (in Flemish education this is categorised as 'Type BA - special education')

Recruitment start date

01/09/2014

Recruitment end date

15/09/2014

Locations

Countries of recruitment

Belgium

Trial participating centre

MPI 't Craeneveld
Serpentsstraat 63
Oudenaarde
9700
Belgium

Sponsor information

Organisation

Flemish Government Education

Sponsor details

Hendrik Consciencegebouw
Koning Albert II laan 15
Brussels
1210
Belgium

Sponsor type

Government

Website

http://onderwijs.vlaanderen.be/

Funders

Funder type

University/education

Funder name

Ghent University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of the results in a paper and submission to a scientific peer-reviewed journal. Also, publication of the results in an internal research report, to be available for all stakeholders (school district, school managing board, teachers, parents and students) is planned.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Henk Weymeis henk.weymeis@ugent.be

Intention to publish date

01/09/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes