跳至主要内容
临床试验/NCT07326423
NCT07326423Enrolling By Invitation不适用

Mental Imagery Therapy for Autism (MITA) - a Randomized Controlled Study of Early Intervention Computerized Brain Training Program for Children With ASD

ImagiRation, LLC1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
1
主要终点
Childhood Autism Rating Scale (CARS-2)

研究概览

简要总结

Mental Imagery Therapy for Autism (MITA) is a highly innovative adaptive language therapy application for children with autism. MITA exercises are limitless in variations, therefore avoiding routinization. Each activity is dynamic, quickly adjusting to the child's exact ability level. All activities are disguised as games that engage children. A 3-year observational clinical study of 6,454 children with ASD demonstrated that children who engaged with MITA showed 2.2-fold greater language improvement than children with similar initial evaluations (p<0.0001). This study explores MITA intervention in a randomized controlled trial of 60 children with ASD. Two- to five-year-old ASD children will be randomly assigned to one of two groups. The MITA group will supplement their conventional language therapy with MITA exercises. The control group will receive treatment-as-usual. The hypothesis is that the MITA group will show greater improvement in developmental milestones.

详细描述

Among primates, humans have exceptionally long and widely distributed fronto-temporal and fronto-parietal tracts (such as the arcuate and superior longitudinal fasciculi), yet the maturation of these pathways depends on early experience. During childhood, these tracts are fine-tuned (largely via myelination and synaptogenesis) through engagement in syntactically rich conversations, imaginative pretend play, and narrative storytelling 5-9. Both biological factors-such as genetically shortened sensitive period for pathways development-and social factors-including limited conversational engagement, low syntactic complexity in daily interactions, lack of storytelling, and excessive passive screen time-can substantially reduce the functional development of these connections and profoundly alter a child's developmental trajectory.

Autistic individuals frequently face a compounding disadvantage from both biological and social factors during early development: a potentially abbreviated critical period, combined with reduced spontaneous engagement in reciprocal conversation, joint attention, and pretend play. These factors limit the experiential scaffolding that typically drives the maturation of fronto-parieto-temporal white-matter tracts.

In a subset of autistic adults these tracts remain structurally and functionally underdeveloped. This compromises the executive function of Prefrontal Synthesis (PFS): the deliberate, effortful co-activation and dynamic binding of distributed visuospatial representations in working memory in order to construct an integrated, manipulable "scene" or situation model. When PFS is impaired, individuals struggle to intentionally generate a unified visuospatial scene that simultaneously contains an agent (subject), an action, and a patient (object) in their correct spatial-temporal relations. Because most syntactic constructions (e.g., active vs. passive voice, relative clauses, prepositional phrases) evolved to efficiently encode precisely these visuospatial-relational configurations, PFS deficits can render sentence comprehension fragmentary or reliant on non-syntactic strategies (e.g., rote memorization or simple word-order heuristics). The autism community refers to this phenomenon as the lack of multi-cue responsivity, or stimulus overselectivity, or tunnel vision (since individuals focus on a single word rather than integrating multiple words within a sentence).

In the absence of robust compensatory mechanisms (which some autistic individuals do develop), this core deficit in constructing and manipulating internal situation models contributes to persistent difficulties with complex language comprehension, abstract reasoning, planning, and flexible adaptive behavior-often resulting in lifelong challenges with independent living for those at the more severely affected end of the spectrum.

About 20 years ago, investigators posed a critical question: if many autistic children show limited interest in conversations, imaginative play, and story listening, could structured, non-conversational exercises be developed that nonetheless train the same fronto-parieto-temporal networks underlying syntactic processing and mental scene construction? Moreover, could such brain training be delivered during the peak sensitive period for language and socio-cognitive development (ages 2-4 years)? To address this challenge, Mental Imagery Therapy for Autism (MITA), a tablet-based intervention was built around highly stylized, brightly colored animated characters that are frequently preferred by autistic children. MITA consists of adaptive, game-like exercises designed to systematically train PFS both within and outside the verbal domain.

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)

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age 2 and 5 years at the time of enrollment
  • diagnosis of ASD confirmed by a study investigator who was experienced in ASD diagnosis.

排除标准

  • a neurodevelopmental disorder of known etiology (e.g., fragile X syndrome)
  • significant sensory or motor impairment,
  • major physical problems such as a chronic serious health condition,
  • seizures at time of entry. Children who developed seizures during the course of the study were not excluded.
  • use of psychoactive medications,
  • history of a serious head injury and/or neurologic disease,
  • alcohol or drug exposure during the prenatal period,
  • CARS-2 total score > 48 (severe ASD).

研究组 & 干预措施

MITA-treatment

Experimental

The treatment group received PFS-training activities emphasizing mental-juxtaposition-of-objects organized into the gamified application MITA

干预措施: Mental Imagery Therapy for Autism (MITA) (Behavioral)

Control

Active Comparator

The active-control group received the same standard clinic-based early intervention but, during the tablet-computer-based therapy unit, used non-MITA applications targeting memory and executive functions (e.g., matching colors and shapes, logical sequences, same/different discrimination, sound discrimination, imitation and musicalization, early literacy and graphomotor skills, animal-sound matching, quantity-number association, comparison, counting, and introductory fractions).

干预措施: General executive function (Behavioral)

结局指标

主要结局

Childhood Autism Rating Scale (CARS-2)

时间窗: the baseline, 6-months, 12-months, 18-months, 24-months, and 30-months

The Childhood Autism Rating Scale, Second Edition (CARS-2) is a 15-item behavioral rating scale developed to quantitatively assess the severity of ASD. CARS-2 works by rating a child's behavior, characteristics, and abilities against the expected developmental growth of a typical child. Each item is scored from 1 to 4: 1 being normal for a child's age, 2 for mildly abnormal, 3 for moderately abnormal, and 4 as severely abnormal. CARS-2 score ranges from 15 (no pathology) to 60 (severe ASD) with 30 being the cutoff rate for a diagnosis of mild autism. Scores 30-37 indicate mild to moderate autism, while scores between 38 and 60 are characterized as severe autism 36.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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