VR Homework Exercises for Selective Mutism Treatment

NCT06882629 | Recruiting DMC

• 1 other identifier: NL86645.018.24
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Selective Mutism; Anxiety Disorder of Childhood

Keywords

Virtual reality; Virtual reality exposure therapy; Intervention; Treatment; Children; Anxiety

Outcome Measures

Primary Outcomes (3)

• SM symptoms (frequent measurement)

  Both parents and teachers are asked to report on SM symptoms. This is done by answering 9 yes/no questions on the child's speaking behavior and communication, including non-verbal communication, making sounds and conversing with others (more yes indicates more speaking behavior). The short assessment is specifically designed for this study in collaboration with experienced SM therapists and a statistician, specialized in SCED's.

  During the baseline period (2 weeks), during the intervention phase (up to 1 year) and during follow-up (3 months after end of intervention phase), three times a week

• SM symptoms (SMQ-NL)

  Evaluated by parents. The SMQ consists of 23 questions that are scored on a 4-point Likert scale ranging from "always" to "never." The symptom subscale consists of 17 questions (0-68; higher scores indicate more SM symptoms), that assess the severity of the symptoms across different situations (family, school and public situations). The second subscale indicates to what extend a child experiences problems due to not speaking in certain situations.

  Baseline (2 weeks), start first phase of intervention (up to 4 months), start second phase of intervention (up to 4 months), start training phase, immediately after intervention (up to 4 months), at follow-up (3 months after end of intervention)

• SM symptoms (Social context of speaking)

  The questionnaire consists of 16 questions assessing (0-64; higher scores indicate less SM symptoms) the social context of speaking assesses the severity of symptoms at school across different social situations (e.g. their own teacher, another teacher, in the classroom or in the presence of peers), speaking behaviour (e.g. whispering and functional speech) and its interference at school. Teachers are asked to evaluate how often child is showing different speaking behaviours and in which social context on a 4-point Likert scale. The questionnaire includes 8 questions that are based on the School Speech Questionnaire (SSQ). For the purpose of our study, the SSQ does not provide enough detail on the child's speaking behaviour, for that reason 8 more questions were included.

  Baseline (2 weeks), start first phase of intervention (up to 4 months), start second phase of intervention (up to 4 months), start training phase (up to 4 months), immediately after intervention, at follow-up (3 months after end of intervention)

Secondary Outcomes (16)

• VR data

  During intervention phase (up to 1 year; every time child uses the VR homework exercises at home)

• VR completion

  During the intervention phase (once a week, up to 1 year)

• VR immersion

  During the intervention phase (once a month, up to 1 year)

• Structured Clinical Interview for DSM-5 Junior (SCID-5-Junior)

  Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)

• Fear Survey Schedule for Children - Revised (FSSC-R or in Dutch VAK 4-12)

  Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)

Other Outcomes (5)

• Adult Self Report (ASR)

  Baseline (2 weeks)

• EMBU-P

  Baseline (2 weeks)

• Communication - Vineland-3-NL

  Baseline (2 weeks)

Study Arms (1)

Intervention

EXPERIMENTAL

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

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

Interventions

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

Intervention

Eligibility Criteria

• Age: 4 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luuk Stapersma: lead

Study Sites (1)

Levvel

Amsterdam, North Holland, 1076 EC, Netherlands

RECRUITING

MeSH Terms

Conditions

Mutism; Anxiety Disorders

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: March 18, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)