Clinical trial NCT03994757: Effects of Routines-Based Early Intervention in Children With Autism Spectrum Disorder
Official title: Effects of Routines-Based Early Intervention in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Routine-Based Early Intervention
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Goal Attainment Scale(GAS)
timeFrame: baseline, up to 24hours,3-month FU
measure: Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)
timeFrame: baseline, up to 24hours,3-month FU
Secondary outcomes:
measure: Childhood Asperger Syndrome Test(CAST)
timeFrame: baseline, up to 24hours,3-month FU
measure: The Children Autism Rating Scale Second Edition(CARS-2)
timeFrame: baseline, up to 24hours,3-month FU
measure: Clancy Behavior Scale
timeFrame: baseline, up to 24hours,3-month FU
measure: Social Responsiveness Scale(SRS)
timeFrame: baseline, up to 24hours,3-month FU
measure: Theory of Mind Inventory-2(ToMI-2)
timeFrame: baseline, up to 24hours,3-month FU
measure: The Berry-Buktenica Developmental Test of Visual-Motor Integration(VMI)
timeFrame: baseline, up to 24hours,3-month FU
measure: Preschool Language Impaired Scale(PLS)/ Language Impaired Scale(LS)
timeFrame: baseline, up to 24hours,3-month FU
measure: Peabody Picture Vocabulary Test-Revised(PPVT-R)
timeFrame: baseline, up to 24hours,3-month FU
measure: Assessment of preschool children's participation(APCP) / Children Assessment of Participation and Enjoyment andPreferences for Activity of Children(CAPE)
timeFrame: baseline, up to 24hours,3-month FU
measure: Functional Independence Measure for Children(WeeFIM)
timeFrame: baseline, up to 24hours,3-month FU
measure: TNO-AZL Preschool children Quality of Life(TAPQOL)/TNO-AZL Quality of Life Questionnaire(TACQOL)
timeFrame: baseline, up to 24hours,3-month FU
measure: Sensory Profile(SP)
timeFrame: baseline, up to 24hours,3-month FU
measure: Parenting Stress Index(PSI)
timeFrame: baseline, up to 24hours,3-month FU
measure: Swanson, Nolan, and Pelham Questionnaire(SNAP)
timeFrame: baseline, up to 24hours,3-month FU
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ying Chung, MD
role: STUDY_DIRECTOR
References: