Effects of Routines-Based Early Intervention in Children With Autism Spectrum Disorder

Chang Gung Medical Foundation

Status: Unknown

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Control; Behavioral: MRBI

Study type: Interventional

Funder types: Other

Identifiers

NCT03994757

201602004A3

Details and patient eligibility

About

Autism Spectrum Disorder (ASD) mainly has social and interaction related problems, and repetitive behaviors or interests. In recent years, studies showed that Routine-Based Early Intervention(RBEI) could increase children's development and enhance skills maintenance. Using the International Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) to assess children can identify different factors under systematic analysis, then improving children's physical functions and self-care abilities. Therefore, this study will design RBEI programs for autistic children, and use ICF-CY to assess the efficacy of RBEIin body function, body structure, and participation for children with autism.

Full description

Study will enroll 30-40 children with ASD, aged 3-9 years. Children will receive subjective and objective assessment for pre-test, post-test and three-monthfollow-up after treatment. After pre-test, children will be randomized and assigned to either the experimental group or the control group. The experimental group willreceive RBEI and the control group willreceive traditional therapy. The treatment period is 12 weeks, 1-2 times a week, 1-2hours each time, and homework is given during the treatment period, allowing parents to do treatment at home. Post-test will be conducted immediately after the end of treatment period, and homework will continue until three-month follow-up conducts. It is expected that after intervention, the physical function, activities and participation, quality of life of the experimental group will improve and significantly different from the control group.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parents are willing to sign written consent form
• Diagnosed as ASD by doctor
• No neurological disease

Exclusion criteria

• Active medical condition
• Progressive or degenerative symptoms or illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

MRBI group

Experimental group

Treatment:

Behavioral: MRBI

Control group

Sham Comparator group

Treatment:

Behavioral: Control