Condition category
Mental and Behavioural Disorders
Date applied
15/05/2020
Date assigned
19/05/2020
Last edited
19/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Socials skills interventions for children and adolescents are widely available, and these interventions generally evaluated as complete program packages. Previous research has shown that social skills programs can be beneficial to children’s and adolescents’ social-emotional development. Still, at this moment, it is unclear which intervention components drive program effects. This study aims to assess the separate effects of cognitive restructuring exercises (i.e., transforming unhelpful thoughts into helpful ones) and psychophysical exercises (i.e., using body movement such as standing up straight to experience more positive cognitions) on children’s self-esteem. Findings from this study may inform intervention developers and practitioners when selecting which interventions to implement.

Who can participate?
Eight- to twelve-year-old children with low self-esteem

What does the study involve?
Schools are randomized into one of three conditions (i.e., cognitive restructuring, psychophysical, or no-treatment control condition) and children from grades four to six that reported lower self-perceived competence and assertiveness are invited to participate in a brief group intervention. 1 week before the start of the intervention, participants whose parents gave consent to participation completed the second measurement occasion. When the intervention is finished, participants complete another measurement occasions, and once more approximately 3 months after the intervention has finished.

What are the possible benefits and risks of participating?
There are no risks of participating in this study. The intervention is free to schools and participating children, and we expect the interventions to enhance children’s self-esteem.

Where is the study run from?
University of Amsterdam (Netherlands)

When is the study starting and how long is it expected to run for?
January 2017 to March 2019

Who is funding the study?
ZonMw (Netherlands Organisation for Health Research and Development)

Who is the main contact?
Brechtje de Mooij, L.S.deMooij@uva.nl

Trial website

Contact information

Type

Scientific

Primary contact

Ms Brechtje de Mooij

ORCID ID

https://orcid.org/0000-0002-0569-3913

Contact details

University of Amsterdam
Nieuwe Achtergracht 127
Amsterdam
1018WS
Netherlands
+31622915656
L.S.deMooij@uva.nl

Type

Scientific

Additional contact

Mr Minne Fekkes

ORCID ID

Contact details

Schipholweg 77
Leiden
2316ZL
Netherlands
+31 634056595
minne.fekkes@tno.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2017-CDE-8097

Study information

Scientific title

Do cognitive restructuring and psychophysical exercises enhance children’s self-esteem? A micro-trial into intervention components.

Acronym

Study hypothesis

This study intends to gain insight into the effectiveness of separate intervention components (i.e. cognitive restructuring and psychophysical exercises), which are included in multifaceted interventions to enhance children's self-esteem.
This study aims to answer two questions:
1. Is a brief group intervention with cognitive restructuring exercises effective in enhancing children’s self-esteem?; (ii) Is a brief group intervention with psychophysical exercises effective in enhancing children’s self-esteem?
2. Is there a difference in effectiveness between a brief group intervention with psychophysical exercises and with cognitive restructuring exercises?

Ethics approval

Approved 26/06/2017, Ethics Review Board of the University of Amsterdam, Department of Child Development and Education (University of Amsterdam, Nieuwe Achtergracht 127, Amsterdam, 1018WS, Netherlands; +3120 525 6686; w.p.m.vandenwildenberg@uva.nl), ref: 2017-CDE-8097

Study design

Randomized three-arm micro-trial with four measurement occasions

Primary study design

Interventional

Secondary study design

Randomised parallel trial

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

Non-clinical low self-esteem

Intervention

Schools are randomized into a condition (i.e., cognitive restructuring condition, psychophysical condition or no-treatment control condition) and children from grades four to six that report experiencing lower self-esteem than the class average will be invited to participate in an intervention.

Schools are randomized into one of the three conditions using a random number generator. Randomization took place before inviting schools to participate in the study.

The interventions consist of four one-hour sessions, which are provided by certified professionals. Participants complete four measurement occasions: approximately five weeks before the start of the intervention, one week before the start of the intervention, one week after the intervention has ended and three months after the intervention has ended.

Three intervention modules will be assessed:
1. A module with cognitive restructuring exercises.
2. A module with psychophysical exercises.
3. No treatment
The modules were developed for the purpose of this study and were inspired by Dutch self-esteem interventions implemented by our clinical partners.

The cognitive restructuring module will consist of cognitive restructuring exercises only. The psychophysical module will consist of psychophysical exercises only from the Rock and Water program.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

All measurements were used at all included measurement occasions ( approximately 5 weeks before the start of the intervention, 1 week before the start of the intervention, 1 week after the intervention has ended and 3 months after the intervention has ended)
1. Self-worth measured using the Rosenberg Self-Esteem Scale
2. Self-perceived competence measured using Self-Perception Profile for Children
3. Self-efficacy measured using General Self-Efficacy Scale

Secondary outcome measures

All measurements were used at all included measurement occasions ( approximately 5 weeks before the start of the intervention, 1 week before the start of the intervention, 1 week after the intervention has ended and 3 months after the intervention has ended)
1. Automatic thoughts measured using the Children's Automatic Thoughts Scale-Negative/Positive
2. Social skills measured using the Social Skills Improvement System-Rating Scales
3. Assertiveness measured using the Social Skills Improvement System-Rating Scales

Overall trial start date

01/01/2017

Overall trial end date

31/03/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

8- to 12-year-old children with low self-esteem compared to class levels, measured using the Self-Perception Scale for Children and the Social Skills Improvement System-Rating Scales-Assertiveness subscale

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

156 split between three arms.

Participant exclusion criteria

1. No signs of low self-esteem
2. Participation in another social-emotional skills intervention
3. Insufficient mastery of Dutch language

Recruitment start date

01/05/2017

Recruitment end date

31/08/2018

Locations

Countries of recruitment

Netherlands

Trial participating centre

University of Amsterdam
Research Institute of Child Development and Education Nieuwe Achtergracht 127
Amsterdam
1018WS
Netherlands

Sponsor information

Organisation

University of Amsterdam

Sponsor details

Nieuwe Achtergracht 127
Amsterdam
1018WS
Netherlands
+3120 525 5820
L.S.deMooij@uva.nl

Sponsor type

University/education

Website

https://www.uva.nl/en

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact-factor journal. This manuscript will also be part of a dissertation on the effective components of social skills training programs for children.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to lack of consent to do so.

Intention to publish date

01/08/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/05/2020: Trial’s existence confirmed by University of Amsterdam.