Characterization of (A)Typical Sensorimotor Pathways in Individuals With Autism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Movement Assessment Battery for Children 3 (MABC3)
Study Overview
Brief Summary
The goal of this interventional study is to understand whether sensorimotor skills could represent an endophenotype for autism, i.e. a specific class of biomarkers that bridges the gap between biological components of a condition and the behavioral/clinical dimensions. Motor and sensory differences are often observed in people with autism and may appear early in development or be shared among family members.
The study will address three main questions:
- What are the developmental effects of early differences in motor and sensory skills?
- Are motor and sensory abilities influenced by family relationships?
- Can studying motor and sensory differences in autism help researchers better understand the biological mechanisms underlying the condition? This study is structured in three topic-oriented work packages (WPs): WP1, a longitudinal assessment of sensorimotor skills as early predictors of later social characteristics in a mixed sample of infant siblings of autistic children (at elevated likelihood of autism) or with typical familial likelihood (no first-degree relatives with autism) (Q1); WP2, a cross-sectional investigation of sensorimotor abilities in autistic children and their parents as compared with typically developing children and their parents (Q2); and WP3, a dense-phenotyping approach to establish, within individuals, associations between traits across behavioral, neural, and molecular levels.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •children aged 2 to 12 years (both autistic and typically developing)
- •Clinical diagnosis of Autism Spectrum Disorder based on clinical judgment according to DSM-5 criteria (for the autism group).
- •being parents of the enrolled children (both autistic and typically developing)
- •infants younger than 24 months of age with a first-degree family member with a clinical diagnosis of Autism Spectrum Disorder.
Exclusion Criteria
- •Presence of medical and/or neurological conditions of clinical significance, including epilepsy.
- •Presence of dysmorphic syndromes or known genetic syndromes.
- •Current use of medications and/or psychotropic drugs.
Arms & Interventions
Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations
All children and their parents enrolled in the study will undergo an assessment of intellectual functioning, and a direct evaluation of motor skills using the Movement Assessment Battery for Children - Thirs Edition (MABC-3). Motor skills will also be assessed indirectly through either a parent or self-completed questionnaire. The motor profile of the participants will be further characterized using kinematic analysis of upper-limb movements during two experimental tasks.
Intervention: clinical assessment (Diagnostic Test)
Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations
All children and their parents enrolled in the study will undergo an assessment of intellectual functioning, and a direct evaluation of motor skills using the Movement Assessment Battery for Children - Thirs Edition (MABC-3). Motor skills will also be assessed indirectly through either a parent or self-completed questionnaire. The motor profile of the participants will be further characterized using kinematic analysis of upper-limb movements during two experimental tasks.
Intervention: Neuropsychological examination (Diagnostic Test)
Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations
All children and their parents enrolled in the study will undergo an assessment of intellectual functioning, and a direct evaluation of motor skills using the Movement Assessment Battery for Children - Thirs Edition (MABC-3). Motor skills will also be assessed indirectly through either a parent or self-completed questionnaire. The motor profile of the participants will be further characterized using kinematic analysis of upper-limb movements during two experimental tasks.
Intervention: Neurophysiological evaluation (Diagnostic Test)
Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations
All children and their parents enrolled in the study will undergo an assessment of intellectual functioning, and a direct evaluation of motor skills using the Movement Assessment Battery for Children - Thirs Edition (MABC-3). Motor skills will also be assessed indirectly through either a parent or self-completed questionnaire. The motor profile of the participants will be further characterized using kinematic analysis of upper-limb movements during two experimental tasks.
Intervention: Genetic evaluation (Diagnostic Test)
Outcomes
Primary Outcomes
Movement Assessment Battery for Children 3 (MABC3)
Time Frame: immediately after the intervention
The Movement ABC-3 (Movement Assessment Battery for Children, Third Edition) is a comprehensive, standardized assessment tool for identifying gross and fine motor coordination difficulties in individuals aged 3 to 25, assessing skills like dexterity, aiming, catching, balance, and locomotion.
Developmental Coordination Disorder Questionnaire (DCDQ)
Time Frame: immediately after the intervention
The Developmental Coordination Disorder Questionnaire (DCDQ) is a parent questionnaire originally developed for estimating gross and fine motor skill difficulties in children. The questionnaire consists of 15 items investigating different subdomains of motor abilities, such as ball skills, complex motor coordination, fine and general motor skills. For each item, parents rate the children's degree of motor coordination on a 5-point scale comparing it to same-age peers.
Adult Developmental Coordination Disorder/Dyspraxia Checklist (ADC)
Time Frame: immediately after the intervention
The Adult Developmental Coordination Disorder/Dyspraxia Checklist (ADC) is a self-report screening tool for adults (16+) to identify potential Developmental Coordination Disorder (DCD/Dyspraxia) by assessing lifelong motor challenges in daily activities
kinematic analysis of two motor tasks
Time Frame: immediately after the intervention
(a) a reaching-and-inserting task involving a ball (ball task), which consists in reaching and grasping a rubber ball (diameter: 6 cm) placed over a support and dropping it in a small basket, provided with a hole large enough (diameter: 7 cm) not to require fine movements; (b) a task requiring grasping a moving ball (ball-rolling task) which requires participants to catch a ball rolling toward them on a curvilinear path off an inclined tabletop. As outcome measure, we will consider the total movement duration (recorded in sec).
Secondary Outcomes
- Magnetic Resonance (MRI)(immediately after the intervention)
- Magnetic Resonance Spectroscopy(immediately after the intervention)
- Exome sequencing(immediately after the intervention)