Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059427) titled 'The Effectiveness of Sensory Integration Therapy for Children with Autism Spectrum Disorder and Intellectual Disabilities' on Oct. 16.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Single blind -participants are blinded Control - No treatment

Primary Sponsor: Institute - Osaka Prefecture University

Condition: Condition - Autism Spectrum Disorder and Intellectual Disabilities Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effectiveness of sensory integration therapy for children with autism spectrum disorder accompanied by intellectual disability and contribute to the development of appropriate support programs. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The intervention group will undergo sensory integration therapy. The program consists of 16 sessions, held twice weekly for 60 minutes each, over an 8-week period. Interventions/Control_2 - The control group will receive usual care(occupational therapy at a child development support center). Sessions will be held 2 to 4 times over a period of 8 weeks, with a frequency of 1 to 2 times per month and a duration of 40 minutes per session.

Eligibility: Age-lower limit - 2 years-old = Gender - Male and Female Key inclusion criteria - 1. Children diagnosed with autism spectrum disorder (including autistic disorder). 2. Children rated as severe on the Childhood Autism Rating Scale Second Edition (CARS2). 3. Children with a developmental index of 70 or below on the New K-type Developmental Test 2001 administered at child guidance centers or similar facilities. Key exclusion criteria - 1. Children with obvious physical disabilities due to conditions such as cerebral palsy. 2. Children with medical restrictions on physical exertion due to conditions such as epilepsy or heart disease. 3. Children who have received sensory integration therapy from an occupational therapist, either currently or in the past. Target Size - 52

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2022 Year 03 Month 30 Day Date of IRB - 2022 Year 03 Month 30 Day Anticipated trial start date - 2022 Year 03 Month 31 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067967

Disclaimer: Curated by HT Syndication.