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Recruiting NCT06882629

VR Homework Exercises for Selective Mutism Treatment

No phase Interventional Selective Mutism Anxiety Disorder of Childhood

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 'Speaking at school, a matter of doing' combined with VR homework exercises.
Who it may be relevant to
Registry conditions: Selective Mutism, Anxiety Disorder of Childhood. Basic parameters: 4 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effect of Virtual Reality Homework Exercises As an Add-On to Behavioral Therapy for Children with Selective Mutism

Overview

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.

Interventions

  • Behavioral '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

Primary outcome measures

  • SM symptoms (frequent measurement) [Time frame: 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) [Time frame: 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) [Time frame: 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 outcome measures (12)
  • VR data [Time frame: During intervention phase (up to 1 year; every time child uses the VR homework exercises at home)]
  • VR completion [Time frame: During the intervention phase (once a week, up to 1 year)]
  • VR immersion [Time frame: During the intervention phase (once a month, up to 1 year)]
  • Structured Clinical Interview for DSM-5 Junior (SCID-5-Junior) [Time frame: 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) [Time frame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)]
  • Child Behaviour Checklist (CBCL) [Time frame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)]
  • Teacher Report Form (TRF) [Time frame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)]
  • Parenting burden questionnaire (OBVL) [Time frame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)]
  • Family Accommodation Scale - Anxiety (FASA) [Time frame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)]
  • Clinical global impression of outcome (CGI) [Time frame: During the intervention phase (up to 1 year), at the end of every therapy session with therapist]
  • Outcome Rating Scale (ORS) [Time frame: During the intervention phase (up to 1 year), at the end of every therapy session with therapist]
  • Therapy evaluation: Visual Facial Anxiety Scale (VFAS) [Time frame: During the intervention (up to 1 year; at the end of each VR session at home and at the end of each therapy session with therapist)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Levvel — Amsterdam

Identifiers

NCT: NCT06882629 · NL86645.018.24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗