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

NCT03994757 | Unknown DMC

• 1 other identifier: 201602004A3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Routine-Based Early Intervention

Outcome Measures

Primary Outcomes (2)

• Goal Attainment Scale(GAS)

  It's an individualized assessment tool, setting goals based on the subject's ability and condition, and specifically describe or quantify the progress of the situation, with a view to regularly assessing and understanding whether the subject has progressed or regressed. The scale is a five-point scale from -2 to 2.

  baseline, up to 24hours,3-month FU

• Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)

  Applicable to infants and young children aged 3-71 months. It includes the clinical assessment and the parent-report questionnaires. It is used to evaluate the motor, language, cognition, social self-care and other fields of infants and young children. It has good inter-tester reliability, retest reliability, internal consistency, content validity and construction validity. Considering to the comprehensive developmental capacity of children with autism, we assess the overall developmental capacity of children with autism up to nine years oldin this study.

  baseline, up to 24hours,3-month FU

Secondary Outcomes (14)

• Childhood Asperger Syndrome Test(CAST)

  baseline, up to 24hours,3-month FU

• The Children Autism Rating Scale Second Edition(CARS-2)

  baseline, up to 24hours,3-month FU

• Clancy Behavior Scale

  baseline, up to 24hours,3-month FU

• Social Responsiveness Scale(SRS)

  baseline, up to 24hours,3-month FU

• Theory of Mind Inventory-2(ToMI-2)

  baseline, up to 24hours,3-month FU

Study Arms (2)

MRBI group

EXPERIMENTAL

Behavioral: MRBI

Control group

SHAM COMPARATOR

Behavioral: Control

Interventions

MRBI BEHAVIORAL

The activities content is designed according to the children's daily routine and goals. It mainly involves bathing activities, eating activities, dressing activities, game activities, social and communication activities, and according to the needs of parents. In the treatment room, after the therapist and parents discuss the intervention methods and suggestions, they will demonstrate the intervention strategies and methods, and let the parents practice the practice, and the therapist will guide them. After discussing with parents, the therapist will give parents a homework related to children's daily routine, let the parents implement at home, and discuss with parents and record before each intervention.

MRBI group

Control BEHAVIORAL

Traditional treatment was directly performed for children in the treatment room by the therapist. The activity content was designed according to the children's goals. After each end of treatment, therapist will give parents a homework related to traditional treatments, let the parents perform at home, and know the parents' performance at home and record before each treatment begins.

Control group

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Active medical condition
• Progressive or degenerative symptoms or illness

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Chia-Ying Chung, MD

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Chia-Ying Chung, MD

CONTACT

+886-3-3281200; chiaying928@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2018
• First Posted: June 21, 2019
• Study Start: August 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 1, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)