VR Homework Exercises for Selective Mutism Treatment

NCT ID: NCT06882629

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Selective Mutism; Anxiety Disorder of Childhood

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

The treatment in this study consists of behavioral therapy for selective mutism (with the protocol 'Speaking 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. For every treatment step 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.

Interventions

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

The treatment in this study consists of behavioral therapy for selective mutism (with the protocol 'Speaking 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. For every treatment step 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luuk Stapersma

OTHER

Sponsor Role: lead

Responsible Party

Luuk Stapersma

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Levvel

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Luuk Stapersma

Role: primary

l.stapersma@levvel.nl

+31 2 890 16 71

Other Identifiers

NL86645.018.24

Identifier Type: -

Identifier Source: org_study_id