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临床试验/NCT05792449
NCT05792449进行中(未招募)不适用

Tele-rehabilitation Program: An Innovative and Sustainable Early Intervention Service for Children With Autism Spectrum Disorders

National University Hospital, Singapore2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
2
主要终点
Mullen's Scale of Early Learning (MSEL)

研究概览

简要总结

In Singapore, Autism Spectrum Disorders (ASD) is ranked number one in disease burden for children 0-14 years of age. The Child Development Unit at the National University Hospital serves 3000 children annually, of which 25-30% of children have been diagnosed with ASD. Therapist roles are to provide interim therapy for these children before entry into community-based Early Intervention Centres (EIPIC), which currently have waiting times of 6-9 months. Current limitations with interim care includes long wait times, high cost for families, lack of manpower and space to serve the patients, poor parental involvement due to their work commitments, parental difficulties attending frequent, needed, in-hospital therapy and difficulty generalizing patient treatment to the home/community setting (decreasing effectiveness). The proposed Telerehabilitation (also called Telerehab) initiative involves the use of video conferencing technology to help address the aforementioned deficits. Offering early intervention through Telerehab will enable previously unattainable benefits such as seeing the child in their home environment, allowing multiple caregivers to have access to the early intervention training, more frequent contact with families and the ability to trouble shoot real life difficulties in real time. The important advantages to the caregivers include less financial burden arising from time off from work and travel, more access to treatment over a longer period of time and ability to access a multidisciplinary team. An additional benefit for the children is they need not travel to unfamiliar environments, which is frequently distressing for children with ASD. Lastly, Telerehab is a sustainable initiative allowing for less manpower to cover the growing number of patients, and the possibility to be implemented in other government run hospitals and clinics facing similar challenges. Elaboration of benefits:1) Importance of parent and caregiver empowerment. Early Intervention in the current model has been predominantly centre based with initiatives to increase caregiver education. A large body of literature suggests that early intervention is highly successful when provided at the age of diagnosis, with younger children yielding better outcomes. Caregiver involvement is vital to long-term success, as they spend a significant amount of time with their child; they can support the generalizations of new skills. National Research Council identifies parent training to be the key component for successful intervention for children with autism. Parent training improves quality of life by reducing parental stress and increasing optimism.2) Addressing nationally identified gaps. The Enabling Master plan recommendations for 2012-2016 (under Ministry of Family and Social Development) identifies gaps in family involvement and support in acquiring necessary skills and knowledge to be competent in helping their children make developmental gains. Child Development Unit (CDU) envisions that Telerehab is a viable avenue for supporting parents in learning EI skills.3) Improving existing parent training programmes. CDU has successfully piloted a parent-training program for children with ASD called SPEECCH. In our study of the impact of this parent-training program, children made measurable progress in all four skill areas assessed (p<0.001). Focus on achievable and observable family- centred developmental goals showed evidence for increased parental understanding of children's learning and behaviour amp; effective use of strategies for facilitating communication and interactions to support their child's development (p<0.001). However this intervention service could not be sustained due to high caseload demands and insufficient manpower. Parent interviews during review visits identified having sustained contact with therapists and parent coaching to be key areas of need. Currently the service provides intervention for 24 children with ASD weekly for one hour across 12 weeks, and continued support for up to 20 weeks (maximum of 16 hours of intervention). Of the new referrals of 150 children with ASD, if a sustained service is to be provided, only a small group of children will receive intervention. In order to address the demand, the frequency and intensity of intervention has had to be sacrificed to be able to provide some service to all patients. Hence to maximize the impact of early intervention, a sustainable model of service delivery using technology through videoconferencing is being proposed.

详细描述

In Singapore, Autism Spectrum Disorders (ASD) is ranked number one in disease burden for children 0-14 years of age. The Child Development Unit at the National University Hospital serves 3000 children annually, of which 25-30% of children have been diagnosed with ASD. Therapist roles are to provide interim therapy for these children before entry into community-based Early Intervention Centres (EIPIC), which currently have waiting times of 6-9 months. Current limitations with our interim care includes long wait times, high cost for families, lack of manpower and space to serve the patients, poor parental involvement due to their work commitments, parental difficulties attending frequent, needed, in-hospital therapy and difficulty generalizing patient treatment to the home/community setting (decreasing effectiveness). Currently, clinic-based environment does not include natural environments for learning development and hence spontaneous generalization is a challenge and impacts child outcomes. Standard interventions do not allow therapists to observe or facilitate a child's behaviour and skills during natural routines. Previous work on telerehab show that it ensures the best outcome for the child. It provides the best modality for therapists to observe the child during these routines in home environments and provide meaningful and relevant strategies in real time. Despite standard therapy, expected significant outcomes of parent training have not been achieved. The key factor has been the need to provide parents with more instruction and practice with the content inside real-life moments and interactions with children. Telerehab facilitates the provision of more sustained opportunities for parent coaching within the home setting (natural environment). A clinic based model of intervention requires transition of children into new environments. The intolerance of children with Autism to changes in their routine/environment is well known; typically presented with acute symptoms of agitation or anxiety. They are frequently distressed in clinical environments, making it difficult for the parent and professionals to continue with the early intervention program. Telerehab provides early intervention in safe and secure natural home contexts of the child thus averting the challenges of transition. Early intervention services provided in the clinical setting are often provided with only one caregiver present. Logistics and travel costs prevent participation of multiple caregivers in early intervention coaching programs. Telerehab makes it feasible for multiple caregivers to participate in early intervention and build their capacities through teleconferencing support from professionals. Previous models of home-based interventions have found to incur high costs for the provider with limited reach. Home visits by professionals incur expense in the form of travel time, travel costs and hence the number of families covered through this is limited. Telerehab maximizes impact of home based interventions without high costs and with wider reach. The cost of early intervention(EI) through Telerehab will be similar to the current costs of clinic-based interventions paid by families. Cost incurred is essentially technology investment and professional manpower investment. Current duration of EI is 16 hours, which is sustainable up to 20 weeks for each family based on current CDU caseloads of 150 new referrals per year. Telerehab proposes to sustain the core intervention across 47 weeks for a duration of 16 hours leading to better sustainability, which also contributes to gains in productivity. This demonstrates the scalability of the Telerehab program.

The current standard program for early intervention treatment is in-clinic therapy based on the Foundational Skills Curriculum (FSC): a framework for early intervention developed from outcomes of an Autism research project conducted in the UK. This framework provides a clear and systematic approach to understanding the child's functioning in 3 core areas of development (across 141 items): Play, Social Interaction, and Communication.

The telerehab program will provide parent coaching on EI through video conferencing using the FSC. The telerehab program aims to improve access to services and facilitate intervention in the natural environment of children and their families by developing video conferencing (VC) as a feasible and acceptable medium to build parent capabilities in EI. The specific service model objectives are to realize positive gains in service efficiency (i.e. reducing the total time and resource utilization per completed intervention course relative to current practice); reduce total costs and non-financial barriers for patients (i.e. access) as well as the total cost to the health system per completed course (i.e. sustainability) and realize positive gains in provider productivity and hence cost-effectiveness (i.e. reduced cost per unit outcome achieved).

Implementation Strategies and Patient Flow CDU receives referrals from polyclinics for children at risk of ASD. These referrals will be scheduled for a developmental assessment by the developmental paediatrician. Baseline assessments will be conducted under the program as well as under standard care. Children who are enrolled into the evaluation study will then continue with either the standard program (clinic-based therapy) or the telerehab program. The program schedule for the patient in terms of type of visits and intervention blocks for both the standard program and telerehab is shown in Annex 1: Program Schedule. The duration of clinic-based intervention sessions will be 60 min while the duration of VC based intervention sessions will be 45 min.

Baseline Assessments Visit 0/1: Child found to be at risk for ASD on clinical evaluation by the developmental paediatrician based on the DSM-5 criteria will be referred for this study. The informed consent will be obtained prior to undergoing any research-related activities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Computer-generated randomisation will be used to randomly assign the participants to one of the intervention groups. Block randomisation will be used to allocate the recruited subjects into one of the interventions. A randomisation list will be generated by the study statistician and envelopes will be prepared. Although the allocation of intervention will be concealed and the study team will not know in advance which subject will receive which intervention, the blinding will not be possible once the intervention is assigned. Assessors of the initial and final MSEL were not told of the intervention status of the patient to avoid bias in outcome assessment. Blinding of the parents is not possible in the context of this study.

入排标准

年龄范围
15 Months 至 48 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 15-48 months
  • Children meet cut off score for Autism Spectrum Disorders (ASD) on Autism Diagnostic Observation Schedule-2 (ADOS): The Autism Diagnostic Observation Schedule (ADOS) is a semi-structured assessment of communication, social interaction, and play (or imaginative use of materials) for individuals suspected of having autism or other pervasive developmental disorders. The ADOS consists of a toddler module and four other modules, each of which is appropriate for children and adults of differing developmental and language levels, ranging from nonverbal to verbally-fluent. The ADOS consists of standardized activities that allow the examiner to observe the occurrence or non-occurrence of behaviours that have been identified as important to the diagnosis of autism and other pervasive developmental disorders across developmental levels and chronological ages.
  • Parent(s) is/are willing and able to give informed consent
  • Families with at least one parent who is digitally literate with the home use of the internet and access to Wi-Fi
  • The same parent(s) or caregiver(s) in attendance for most intervention sessions and all review sessions in order to monitor performance across outcome measures

排除标准

  • Participants not having access to the internet will be excluded
  • Received or receiving other treatment or interventions (Note: this is an exclusion criterion but not a withdrawal criterion)
  • Children with genetic and other associated auditory or visual impairment and/or seizure disorders

结局指标

主要结局

Mullen's Scale of Early Learning (MSEL)

时间窗: Change from baseline MSEL assessment at study completion, an average of 1 year

MSEL is a standardized developmental assessment to examine developmental skills using 5 subscales: Gross Motor, Visual Reception, Fine Motor, Expressive Language and Receptive Language. For each scale, the assessment derives a T-score with a mean of 50 and standard deviation of 10, a percentile score, and an age equivalent. An early learning composite (ELC) score is calculated from the total of the subscale scores (except the gross motor scale) with a mean of 100 and standard deviation of 15 (Bacon et al., 2014). The use of MSEL subscale scores allow for greater granularity of analysis, to examine the impact of intervention on specific functions of the child and for separate assessment of verbal and non-verbal abilities (Vismara et al, 2009). Differences in the T-scores on the subscales of the MSEL as well as MSEL ELC from baseline to program conclusion will be calculated and compared between the two intervention groups. The margin of non-inferiority is set at 5 units.

次要结局

  • Vineland Adaptive Behaviour Scales (VABS-III)(Change from baseline VABS-III assessment at study completion, an average of 1 year)
  • Joint Engagement Rating Inventory (JERI)(Change from baseline parent-child interaction based on JERI at study completion, an average of 1 year)
  • Parenting Stress Index-Short Form (PSI-SF)(Change from baseline PSI-SF assessment at study completion, an average of 1 year)
  • Families in Early Intervention Quality of Life (FEIQoL)(Change from baseline FEIQoL assessment at study completion, an average of 1 year)
  • Cost survey(Change from baseline cost assessment at study completion, an average of 1 year)
  • Parent Satisfaction Survey(At study completion, an average of 1 year)
  • NDBI-Fi(Change from baseline parent intervention fidelity based on NDBI-Fi at study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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