VR Homework Exercises for Selective Mutism Treatment

Recruiting · NCT06882629 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

'Speaking at school, a matter of doing' combined with VR homework exercises

What this trial is about

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.

Who can take part

Age range

4 Years to 13 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

The child meets the DSM-5 criteria for SM (as a primary classification).
The child is attending primary school.
Referred to an academic center for Child and Adolescent Psychiatry (Levvel) for diagnosis and treatment of SM
Psychiatric comorbidity is permitted, given that SM is the primary treatment target.
Medication use is permitted, if stable for at least 4 weeks prior to the start of treatment.

Exclusion criteria

No participating parents.
Parents do not have sufficient mastery of the Dutch language.
Parents or child have an estimated IQ below 75.
The child needs inpatient treatment.
Children with a (medical) condition that is a contraindication for using a VR headset (epilepsy, claustrophobia, facial condition, sensitive vestibular system, panic attacks)
Parents receiving parental guidance which is not part of the standard treatment program.
Children that have received protocolled behavior therapy for SM in the past 12 months.

Where it is running

1 location listed.

Levvel - Amsterdam, North Holland, Netherlands

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →