VR Homework Exercises for Selective Mutism Treatment

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое '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

Первичные конечные точки

• SM symptoms (frequent measurement) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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)]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Levvel — Amsterdam

Идентификаторы

NCT: NCT06882629 · NL86645.018.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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