Condition category
Mental and Behavioural Disorders
Date applied
11/01/2019
Date assigned
17/01/2019
Last edited
18/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Children can show aggressive reactions but also depressive and withdrawn reactions to daily life challenges such as trying to belong to a group, bullying, denial or other social situations. To a certain level, these challenges belong to normal development. However, these early conduct and emotional problems are found to be important predictors of depression, delinquency, school dropout and psychological disorders later on in life. Reducing these problems at an early age with indicative preventive interventions directed at social interactions may prevent escalation into severe problems that are harder to treat.This study examines whether Topper Training (“Kanjertraining” in Dutch) is effective in reducing emotional, conduct and peer problems, self-esteem, depression and peer victimisation.

Who can participate?
This training is directed at children aged 8 to 11 years with mild to severe emotional and /or behavioural problems and their parents.

What does the study involve?
Children are randomly assigned to either the treatment or the waitlist group. The treatment consists of ten lessons of 1.5 hour given to children and parents. The waitlist group receives the training half a year after the other group. Children practice social skills and make use of four coloured caps in role-plays. These caps symbolize four different ways of reacting in social situations. Children also discuss social themes and dilemmas. Every session ends with a physical trust-building exercise. Parents are made aware of their role as a model for their child and practice the same skills as the children. Moreover, a ‘Topper’ way of thinking and acting as a parent is taught wherein children’s positive intentions are affirmed and children’s sense of responsibility is stimulated by reducing psychological control over the child.Children and parents learn to become aware of their behaviour, to reflect on it and to choose for behaviour that is in line with their intentions: be authentic and trustworthy.

What are the possible benefits and risks of participating?
Parents, teachers and children complete questionnaires before, after and half a year after the intervention. We compare the groups on emotional, conduct and peer problems, self-esteem, depression and victimisation. We hypothesize that children and parents will benefit from the training in these areas. The intervention is already given the same way for many years and no risks to participants are known. Children and parents may become more conscious of their feelings and behaviors by filling in the questionnaires.

Where is the study run from?
The training studied here is given at the Topper Training Foundation in Almere, The Netherlands. Children are recruited in primary schools and public health institutions.

When is the study starting and how long is it expected to run for?
The first training starts in September 2010, the second in February 2011 and the third in September 2011.

Who is funding the study?
Toppertraining Foundation

Who is the main contact?
Lilian Vliek
lilian@kanjertraining.nl

Trial website

N/A

Contact information

Type

Public

Primary contact

Dr Lilian Vliek

ORCID ID

http://orcid.org/0000-0002-1740-8964

Contact details

Edvard Munchweg 41
Almere
1328MB
Netherlands
0031-(0)365489405
lilian@kanjertraining.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of Topper Training on psychosocial problems, self-esteem, and peer victimisation in 8- to 11- year-olds: a randomised controlled trial

Acronym

TopperEffect

Study hypothesis

1. Toppertraining will effectively reduce emotional problems, conduct problems, peer problems and victimisation, and will increase self-esteem.
2. Toppertraining will cause children to cope more adequately with the challenges or problems that they face.
3. Toppertraining will reduce the impact that problems have on the lives of the children.

Ethics approval

The Faculty of social and behavioural sciences of the University of Amsterdam, 04/12/2014, ref. 2014-CDE-3827.

Study design

Randomized controlled trial with two parallel conditions (intervention and waitlist group), with three measurement points.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Problems in social interactions

Intervention

The intervention consists of ten 90-minute group sessions given every two weeks. In the first half hour, children and parents are trained together, after which they are trained in separate groups. After each meeting, parents are given background information and homework assignments to do at home. The sessions follow a detailed protocol. Each session starts with a rehearsal of exercises from the previous sessions. Thereafter, the trainer introduces the theme of the session through a story. Children practice social skills and make use of four coloured caps in role-plays. They also discuss social themes and dilemmas. Every session ends with a physical trust-building exercise.

The first three sessions are directed at basic social skills: presenting oneself, eye contact, giving and receiving compliments, and expressing and interpreting emotions. In the fourth session, children practice reacting to bullying and troublesome situations. Special attention is paid to bystander behaviour: children practice ignoring or walking away from negative behaviour. The themes of the fifth, sixth and seventh sessions are showing interest in one another, trust, and friendship, respectively. In the seventh and eighth sessions, the children give each other feedback: children receive suggestions from their peers for behavioural change. The ninth session reminds children of the people who love them and stresses their worth to those people. The last session is the diploma ceremony. Parents are made aware of their role as a model for their child and practice the same skills as the children. Moreover, a ‘Topper’ way of thinking and acting as a parent is taught wherein children’s positive intentions are affirmed and children’s sense of responsibility is stimulated by reducing psychological control over the child.

The waitlist group has to wait half a year and receives the same intervention thereafter. Children were measured before, after and half a year after treatment (follow-up).

Children are randomised into treatment or waitlist group after pretest measurement in a 3:2 ratio using a simple randomisation procedure (a throw of the dice).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Collected at pre-training baseline (05/2010 and 2011), post-training (12/2010 and 2011), and follow-up (05/2011 and 2012):
1. Emotional, peer, and conduct problems and prosocial behavior and impact of problems by the Strengths and Difficulties Questionnaire (SDQ) filled in by parents and teachers,
2. depression measured by self-report Children’s Depression Inventory,
3. self-esteem measured by Self-Perception Profile for Children (SPPC).

Secondary outcome measures

Self-perceived victimisation and bullying, measured by questions of the Topper questionnaire at baseline (05/2010 and 2011), post-training (12/2010 and 2011), and follow-up (05/2011 and 2012).

Overall trial start date

01/10/2009

Overall trial end date

01/06/2012

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Children who are in primary school
2. Aged between 8 and 11 years
3. Experience internalising and/or externalising problems in social interactions
4. Motivated to follow the training programme (parents also motivated).

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

90

Participant exclusion criteria

N/A

Recruitment start date

01/02/2010

Recruitment end date

01/07/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Topper Training Foundation
Edvard Munchweg 41
Almere
1328 MB
Netherlands

Sponsor information

Organisation

Topper Training Foundation

Sponsor details

Edvard Munchweg 41
Almere
1328 MB
Netherlands
0031(0)365489405
info@kanjertraining.nl

Sponsor type

Other

Website

www.kanjertraining.nl

Funders

Funder type

Charity

Funder name

Topper Training Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This study is part of a PhD project. Therefore an article is part of the dissertation of Lilian Vliek. We also intend to publish this in an international scientific journal in 2019.

2015 results published in thesis: https://www.kanjertraining.nl/wp-content/uploads/2015/08/effects_of_eanjertraining_dissertation-1.pdf

IPD sharing statement: the datasets generated during and/or analysed during the current study will be stored in a publicly available repository at the Open Science Framework (osf.io/3ke9j).

The raw anonymised data will be available after publication of the results in an international journal. Open Science Framework is an open access website. Researchers can contact the author if they want to analyse the data.

All parents signed a consent form to indicate that they agreed to participate in the study.

Intention to publish date

01/02/2019

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/01/2019: Internal review.