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

NCT ID: NCT03994757

Last Updated: 2019-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MRBI group

Group Type EXPERIMENTAL

MRBI

Intervention Type 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.

Control group

Group Type SHAM_COMPARATOR

Control

Intervention Type 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.

Interventions

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MRBI

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.

Intervention Type BEHAVIORAL

Control

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chia-Ying Chung, MD

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chia-Ying Chung, MD

Role: CONTACT

+886-3-3281200 ext. 8148

Facility Contacts

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Chia-Ying Chung, MD

Role: primary

+886-3-3281200 ext. 8148

Other Identifiers

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201602004A3

Identifier Type: -

Identifier Source: org_study_id

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