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The Effect of Virtual Reality Homework Exercises As an Add-On to Behavioral Therapy for Children with Selective Mutism
Selective mustism (SM) is an anxiety disorder that manifests in childhood. Children with Children with SM do not speak in certain social situations where this is expected of them. For example, a child may talk at home, but is afraid to speak at school. The goal of this clinical trial is to determine the efficacy of behavioral therapy for children with selective mutism (SM) combined with virtual reality (VR) homework exercises. Virtual Reality Exposure is an effective treatment for adults with anxiety disorders. The main questions to answer are: * Is behavioral therapy combined with VR homework exercises effective in the treatment of SM? * Which familial factors contribute to a positive treatment outcome and homework adherence? A single-case experimental design (SCED) will be used to evaluate the efficacy of the treatment. The child's speaking behavior at baseline will be compared to the child's speaking behavior in the different phases of the intervention. Participants will: * Follow individual therapy sessions at school. * Practice with the VR homework exercises at least once a week. * Parents and teachers will evaluate the child's speaking behavior.
The treatment in this study consists of behavioral therapy for SM (with the protocol 'Talking at school, a matter of doing') with the addition of the VR homework exercises. The protocol consists of 10 steps that help the child to gain confidence while speaking at school. The individual therapy sessions are provided at school. For every step of the protocol there are VR homework exercises available. Families receive a VR headset for the duration of the study. Parents are instructed to work on the VR homework exercises at least once a week and encouraged to work on the VR homework exercises several times a week. On average, treatment is approximately 25 weeks.
Age
4 - 13 years
Sex
ALL
Healthy Volunteers
No
Levvel
Amsterdam, North Holland, Netherlands
Start Date
March 1, 2025
Primary Completion Date
April 1, 2027
Completion Date
June 1, 2027
Last Updated
March 18, 2025
15
ESTIMATED participants
'Speaking at school, a matter of doing' combined with VR homework exercises
BEHAVIORAL
Lead Sponsor
Luuk Stapersma
NCT06352463
NCT05967468
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03932032