The Effect of Virtual Reality Homework Exercises As an Add-On to Behavioral Therapy for Children with Selective Mutism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- SM symptoms (frequent measurement)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •No participating parents.
- •Parents do not have sufficient mastery of the Dutch language.
- •Parents or child have an estimated IQ below
- •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.
结局指标
主要结局
SM symptoms (frequent measurement)
时间窗: 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
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.
SM symptoms (Social context of speaking)
时间窗: 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)
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.
SM symptoms (SMQ-NL)
时间窗: 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)
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.
次要结局
- 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))
- Child Behaviour Checklist (CBCL)(Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention))
- VR data(During intervention phase (up to 1 year; every time child uses the VR homework exercises at home))
- Teacher Report Form (TRF)(Baseline (2 weeks), immediately after intervention (up to 1 year) and at follow-up (3 months after end of intervention))
- Parenting burden questionnaire (OBVL)(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)(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)(During the intervention phase (up to 1 year), at the end of every therapy session with therapist)
- Outcome Rating Scale (ORS)(During the intervention phase (up to 1 year), at the end of every therapy session with therapist)
- VR completion(During the intervention phase (once a week, up to 1 year))
- Therapy evaluation: Visual Facial Anxiety Scale (VFAS)(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))
- Monthly VR evaluation(During the intervention (once a month, up to 1 year))
- Qualitative interview parents(Immediately after intervention (up to 1 year), and at follow-up (3 months after the end of the intervention))
- Qualitative interview therapists(Immediately after intervention (up to 1 year))
- Qualitative interview child(Immediately after intervention (up to 1 year))
研究者
Luuk Stapersma
Principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)