VR Homework Exercises for Selective Mutism Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-13
SponsorLuuk Stapersma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • '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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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
2

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.

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)
3

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.

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 outcomes

1

VR data

Each parent has a unique ID to sign-in to a web-based application that is used to guide the child through the virtual school. Parents will indicate that when the next exercise is presented. These responses are saved. Every time the parent signs in, the total time and the time spent playing the different games will be automatically stored on a secured database. This will be recorded in seconds.

Time frame
During intervention phase (up to 1 year; every time child uses the VR homework exercises at home)
2

VR completion

Parents are asked to track the time they spend working on the VR homework exercises on a VR tracking sheet on a weekly basis. They are asked to fill out how long and which days they practiced. The number of days practiced will be divided by the total number of days in the week. This yields a percentage of VR completion per week.

Time frame
During the intervention phase (once a week, up to 1 year)
3

VR immersion

Specifically for this study three questions were designed to measure the level of immersion children experience while practicing with the VR. Children are asked to rate their immersive experience on 4-point Likert scale ranging from strongly disagree to strongly agree.

Time frame
During the intervention phase (once a month, up to 1 year)
4

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

Semi-structured interview for children and adolescents between 8 -18. The interview is suitable for both children and their parents. The SCID-5 Junior consists of 17 modules to classify DSM-5 disorders. The SCID-5 Junior is used in standard clinical care, to check for additional anxiety disorders and disorders that might look like SM. The SCID-5 Junior will be administered in the same manner as in regular clinical care, meaning that parents only report on the modules: anxiety, autism and obsessive-compulsive behavior, unless there are indications that suggest the presence of another co-morbid disorder.

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

Other outcomes

1

Adult Self Report (ASR)

The ASR is a self-report questionnaire for adults (ages 18-59) assessing aspects of adaptive functioning and problems. The questionnaire provides a Total score (123 items, 0-252, higher scores indicate more behavioral and emotional problems) and scores for an Internalizing and Externalizing subscale.

Time frame
Baseline (2 weeks)
2

EMBU-P

The EMBU-P (with the Swedish name Egna Minnen Beträffende Uppfostran - Parent version) rates the parents' own rearing behavior with their children. Rearing behavior is scored on across 4 dimensions: Rejection, Emotional Warmth, Control Attempts and Favoring Subject. It has 83 items (higher scores per dimension indicate more of that rearing behavior, which can be positive or negative).

Time frame
Baseline (2 weeks)
3

Communication - Vineland-3-NL

This questionnaire evaluates adaptive behavior on five domains: communication, daily living skills, socialization, motor skills and maladaptive behavior. The questionnaire is suitable for both parents and teachers. Only the domain communication will be assessed as the presence of speech and language problems is often linked to SM.

Time frame
Baseline (2 weeks)
4

Immersive Tendencies Questionnaire - Parent report

For the purpose of this study, the questions were rephrased to turn the original questionnaire into a parent-report. Parents are asked to evaluate their child's immersive tendencies on a 7-point likert scale, ranging from strongly disagree to strongly agree (10 items, 0-70, higher scores indicate more immersive tendencies).

Time frame
Baseline (2 weeks)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Luuk Stapersma

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor institution