Early Remote Intervention in Autism: a Randomized Noninferiority Clinical Trial Comparing Semi-intensive Early Start Denver Model (ESDM) Intervention With Remote Parental Training/ Supervision Versus Intensive ESDM Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL)
研究概览
简要总结
The Early Start Denver Model (ESDM) has shown its efficiency in the early management of ASD.
The study aims to evaluate the efficiency of a new type of management based on a semi-intensive center-based intervention (8h per week) coupled with a MOOC (Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations) for remote parental training/supervision. The goal is to determine if compared to the ESDM reference intervention (15h per week), this type of care can bring, a sufficient improvement in child development course and decreased symptoms of autism in young children, and if it could be, therefore, better suited to the needs of children and their family, bypassing the previously stated obstacles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ASD based on the Diagnosis and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria;
- •Diagnosis of ASD on the Autism Diagnosis Observation Schedule (ADOS-2) and Autism Diagnosis Interview (ADIR) for toddlers (we will include children above or equal to 13, which is the research cut-off);
- •Aged between 15 and 36 months;
- •DQ of 30 or above at the MSEL
- •Sign informed consent form by both parents
排除标准
- •A neurodevelopmental disorder with known etiology (e.g. fragile X syndrome, Rett syndrom)
- •Significant sensory or motor impairment
- •Major physical problems such as a chronic serious health condition
- •History of a serious head injury and/or neurologic disease
- •Seizures at time of entry
- •Use of psychoactive medications (7 ) Families unavailable for the intervention and the followup over a period of 12 months
- •(8) Impossibility for family to have access to the MOOC
研究组 & 干预措施
ESDM 15h
This arm receives 15 hours per week of ESDM intervention from ESDM therapists. The parents benefit from a 20 hour parent training program delivered in the participating center.
干预措施: ESDM intervention (Other)
ESDM 8h + MOOC
This arm receives 8 hours per week of ESDM intervention from ESDM therapists in addition to whatever community service the parents choose. The parents benefit from a training program remotely delivered via a MOOC platform as well as parental supervision of sessions delivered at home 1 hour per week for the duration of the study.
干预措施: ESDM intervention (Other)
ESDM 8h + MOOC
This arm receives 8 hours per week of ESDM intervention from ESDM therapists in addition to whatever community service the parents choose. The parents benefit from a training program remotely delivered via a MOOC platform as well as parental supervision of sessions delivered at home 1 hour per week for the duration of the study.
干预措施: MOOC (Other)
结局指标
主要结局
The gain in developmental quotient measured using the Mullen Scales of Early Learning (MSEL)
时间窗: From day 0 to months 12
Minimum = 49 (worse outcome) and maximum = 155 (better outcome)
次要结局
- Assessment of child autism symptoms and change in autism symptoms using ADOS-2(At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention)
- Assessment of child behavioral adaptation using The Vineland Adaptive Behavior Scales second version (VABS-2)(At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention)
- Assessment of sensory reactivity using The Dunn's Sensory Profile for toddlers(At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention)
- Assessment of the parent burden and quality of life using the CareQuol-7D(At baseline, 6 months after the set up of the intervention and at 12 months after the set up of the intervention)