Clinical trial NCT06882629: VR Homework Exercises for Selective Mutism Treatment
Official title: The Effect of Virtual Reality Homework Exercises As an Add-On to Behavioral Therapy for Children with Selective Mutism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Selective Mutism
Anxiety Disorder of Childhood
Keywords: Virtual reality
Virtual reality exposure therapy
Intervention
Treatment
Children
Anxiety
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 15
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: SM symptoms (frequent measurement)
timeFrame: 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
measure: SM symptoms (SMQ-NL)
timeFrame: 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)
measure: SM symptoms (Social context of speaking)
timeFrame: 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:
measure: VR data
timeFrame: During intervention phase (up to 1 year; every time child uses the VR homework exercises at home)
measure: VR completion
timeFrame: During the intervention phase (once a week, up to 1 year)
measure: VR immersion
timeFrame: During the intervention phase (once a month, up to 1 year)
measure: Structured Clinical Interview for DSM-5 Junior (SCID-5-Junior)
timeFrame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
measure: Fear Survey Schedule for Children - Revised (FSSC-R or in Dutch VAK 4-12)
timeFrame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
measure: Child Behaviour Checklist (CBCL)
timeFrame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
measure: Teacher Report Form (TRF)
timeFrame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
measure: Parenting burden questionnaire (OBVL)
timeFrame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
measure: Family Accommodation Scale - Anxiety (FASA)
timeFrame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention)
measure: Clinical global impression of outcome (CGI)
timeFrame: During the intervention phase (up to 1 year), at the end of every therapy session with therapist
measure: Outcome Rating Scale (ORS)
timeFrame: During the intervention phase (up to 1 year), at the end of every therapy session with therapist
measure: Therapy evaluation: Visual Facial Anxiety Scale (VFAS)
timeFrame: 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)
measure: Qualitative interview child
timeFrame: Immediately after intervention (up to 1 year)
measure: Monthly VR evaluation
timeFrame: During the intervention (once a month, up to 1 year)
measure: Qualitative interview parents
timeFrame: Immediately after intervention (up to 1 year), and at follow-up (3 months after the end of the intervention)
measure: Qualitative interview therapists
timeFrame: Immediately after intervention (up to 1 year)
Other outcomes:
measure: Adult Self Report (ASR)
timeFrame: Baseline (2 weeks)
measure: EMBU-P
timeFrame: Baseline (2 weeks)
measure: Communication - Vineland-3-NL
timeFrame: Baseline (2 weeks)
measure: Immersive Tendencies Questionnaire - Parent report
timeFrame: Baseline (2 weeks)
measure: Intake questionnaire
timeFrame: Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after the end of the intervention)
Locations:
city: Amsterdam
country: Netherlands
facility: Levvel
state: Noord-Holland
Study officials:
References: