Plain English Summary
Background and study aims
Social anxiety is characterized by a fear of negative evaluation by peers, distress in social situations and the avoidance of social situations that might provoke anxiety. Socially anxiety in childhood and adolescents has been related to various negative wellbeing outcomes (such as fewer friendships and impaired social skills). To prevent and treat social anxiety, many interventions have been developed. Two dominant intervention components are generally included in these programs: exposure and cognitive restructuring. Currently, little evidence is available for the separate effectiveness of these intervention components.
To better understand the effectiveness of interventions aimed at reducing social anxiety in children, this study aims to assess the separate and combined effects of two dominant intervention components: exposure and cognitive restructuring. These two components are generally included side by side in interventions aimed at reducing (social) anxiety.
Who can participate?
Eight- to twelve-year-old children with emerging social anxiety symptoms as measured using the Social Anxiety Scale for Adolescents.
What does the study involve?
Schools are randomized into a condition (i.e., exposure condition, cognitive restructuring condition, or combination condition) and children from grades four to six that report experiencing more social anxiety than the class average will be invited to participate in an intervention. 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.
What are the possible benefits and risks of participating?
There are no risks for children’s participation in this study. Participation in this study’s interventions is free to schools and their students. The intervention modules implemented and evaluated in this study teach children how to (better) manage anxiety provoking situations. This may reduce their experience of anxiety in social situations, and in turn may improve their self-esteem and may lead to more positive peer interactions.
Where is the study run from?
University of Amsterdam, Department of Child Development and Education, Netherlands
When is the study starting and how long is it expected to run for?
May 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
Minne Fekkes
minne.fekkes@tno.nl
Trial website
Contact information
Type
Scientific
Primary contact
Ms Brechtje de Mooij
ORCID ID
https://orcid.org/0000-0002-0569-3913
Contact details
Nieuwe Achtergracht 127
Amsterdam
1018WS
Netherlands
+31 622915656
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-8033
Study information
Scientific title
Effective components of social anxiety interventions for children with emerging social anxiety symptoms
Acronym
Study hypothesis
This study intends to gain insight into the effectiveness of separate intervention components (i.e., exposure and cognitive restructuring), which are generally combined in multifaceted intervention programs to reduce children's social anxiety symptoms.
This study aims to answer two questions:
1. Is a brief group intervention using exposure, cognitive restructuring, or a combination of both, effective in reducing social anxiety symptoms in children?
2. Is there a difference in effectiveness between the brief group interventions using exposure, cognitive restructuring, or a combination of both components?
Ethics approval
Approved 26/07/2017, Ethics Review Board of the Faculty of Social and Behavioral Sciences (Nieuwe Achtergracht 129B, 1018WS Amsterdam, the Netherlands; +31(0)205256686; w.p.m.vandenwildenberg@uva.nl), ref: 2017-CDE-8033
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
Emerging social anxiety
Intervention
Schools are randomized into a condition (i.e., exposure condition, cognitive restructuring condition, or combination condition) and children from grades four to six that report experiencing more social anxiety than the class average will be invited to participate in an intervention.
Schools were matched based on their size and the level of education children generally continue to (a schools’ average standardized test score). Using a random number generator, schools were assigned a number between 1 and 3, which indicated which condition they would be assigned to.
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 exposure exercises
2. A module with cognitive restructuring exercises
3. A module combining exposure and cognitive restructuring exercises
The modules were developed for the purpose of this study and were inspired by evidence-based anxiety interventions, such as Cool Kids.
The exposure module will consist of exposure exercises only, using social situations that are common in the school context (i.e., answering a question, giving an oral presentation. The cognitive restructuring module will consist of cognitive restructuring exercises only and will use the same social situations in a hypothetical manner. The combination module will include both cognitive restructuring exercises and exposure exercises.
All modules will consist of four one-hour sessions and will be provided by certified professionals.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
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.
1. Social anxiety symptoms measured using the self-reported Social Anxiety Scale for Adolescents
2. Distress measured using a self-report measure developed for the purpose of this study
3. Avoidant and approach behavior measured using a self-report measure developed for the purpose of this study
4. Automatic thoughts measured using the Children’s Automatic Thoughts Scale – Positive/Negative
Secondary outcome measures
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.
1. Internalizing behavior measured using the subscale Internalizing behavior from the self-report version of the Social Skills Improvement System – Rating Scales
2. Social skills measured using multiple subscales from the self-report version of the Social Skills Improvement System – Rating Scales
3. Self-efficacy measured using a self-report measure developed for the purpose of this study
4. Self-perceived competence measured using the Dutch translation of the Self-perception Scale for Children
Overall trial start date
01/01/2017
Overall trial end date
31/03/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Eight- to twelve-year-old children with emerging social anxiety symptoms as measured using the Social Anxiety Scale for Adolescents.
Participant type
Other
Age group
Child
Gender
Both
Target number of participants
156 split between three arms
Participant exclusion criteria
1. No signs of social anxiety
2. Participation in another social anxiety 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
Department 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
+31 205255820
L.S.deMooij@uva.nl
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
ZonMw
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. A second publication might assess the mediation of intervention effects.
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 share the data.
Intention to publish date
01/06/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list