Autism Spectrum DisorderNCT03994757
Effects of Routines-Based Early Intervention in Children With Autism Spectrum Disorder
A study testing MRBI in people with Autism Spectrum Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- MRBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents are willing to sign written consent form
- Diagnosed as ASD by doctor
- No neurological disease
Who cannot join
- Active medical condition
- Progressive or degenerative symptoms or illness
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Chia-Ying Chung, MD, +886-3-3281200 ext. 8148, chiaying928@yahoo.com
Chia-Ying Chung, MD
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- MRBI, Control
- Keywords
- Autism Spectrum Disorder, Routine-Based Early Intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRBIBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MRBI group | Experimental | Not described Receives: Behavioral: MRBI |
| Control group | Sham comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, up to 24hours,3-month FU
Secondary outcomes (14)
Childhood Asperger Syndrome Test(CAST)
This parent-reported questionnaire is used to screen the autistic characteristic of children with high-function autism or Asperger, including repetitive behavior, social dysfunction and communication deficit, etc. Available age is 4-11. This 2-point questionnaire has 37 items, including 6 non-scoring general developmental items and 31 target items. At the end has additional items identifying whether child has special needs.Retest reliability is .83. Study showed that CAST can screen out 87.5% of children with Asperger.
Measured: baseline, up to 24hours,3-month FU
The Children Autism Rating Scale Second Edition(CARS-2)
This 5-point scale is used to identify whether child is autism. Applicable to preschool children.The internal consistency is .92-.95, inter-rater reliability is .85-.97, and retest reliability is .89-.99.
Measured: baseline, up to 24hours,3-month FU
Clancy Behavior Scale
This 3-point scale is used to screen whether child is autism. Available age is 2-5. The administered time is 10 minutes in average. Total score above 14 shows child has autism tendency and above 23 shows child is autism.It has good sensitivity.
Measured: baseline, up to 24hours,3-month FU
Social Responsiveness Scale(SRS)
Filled out by parents or teachers, the average time is 15-20 minutes. It is used to assess the social barriers of children aged 4-18 and to determine whether a child has autism. It is a four-point scale with a score of 0-3. The internal consistency is 0.91-0.97, retest reliability is 0.84-0.97, inter-rater reliability is 0.76-0.95.
Measured: baseline, up to 24hours,3-month FU
Theory of Mind Inventory-2(ToMI-2)
A questionnaire for assessing children's social cognition ability, which is a five-point questionnaire for continuity. It can be filled out by parents or filled by children with good reading skills and oral skills. Applicable age is 2-13 years old, including 60 topics. Each question is described as a state, including emotional cognition, mental state understanding, pragmatics, etc. The person who fills the mark is marked with a slash on the line of "definitely not"," probably not", "undecided", "probably", and "definitely" to respond. The internal consistency is 0.96.
Measured: baseline, up to 24hours,3-month FU
The Berry-Buktenica Developmental Test of Visual-Motor Integration(VMI)
It is used to assess children's ability to visually recognize and motor coordination. Applicable for 3 years old to adult, and the evaluation time is about 15-20 minutes. It contains high retest reliability and internal consistency.
Measured: baseline, up to 24hours,3-month FU
Preschool Language Impaired Scale(PLS)/ Language Impaired Scale(LS)
It is used to assess whether children have problems in communication, including sound, articulation, intonation, fluency, vocabulary comprehension and expression. Suitable for children from 3 to 5 years old (PLS) and over 5 years old (LS). This 0-1 point measure includes 3 subscales: comprehension, expression and language development. The higher percentile rank represent better outcome. The retest reliability and the inter-tester reliability are 0.91-0.97.
Measured: baseline, up to 24hours,3-month FU
Peabody Picture Vocabulary Test-Revised(PPVT-R)
It is used to assess children's vocabulary comprehension and can also be used as a child intelligence test. Suitable for children from 3-12 years old. The test is based on the number of questions corresponding to the child's physiological age, and the test is tested backward after answering the six questions (the highest level) in the eight consecutive questions, and the test is completed after the eight consecutive questions (basic level). Questions below the basic level are considered correct. Internal consistency and inter-tester reliability are good.
Measured: baseline, up to 24hours,3-month FU
Assessment of preschool children's participation(APCP) / Children Assessment of Participation and Enjoyment andPreferences for Activity of Children(CAPE)
Used to measure children's learning, playing, development skills and personal qualities. Applicable to children aged 2-6 (APCP) and 6-21 (CAPE), the parents score this questionnaire according to the child's performance in the past four months.There are 45 questions in total.First, check if the child have done this activity (1 point means yes, 0 points means no), then check the frequency child doing this activity (1 point, means only once in the last four months, to 7 points, means every day in the past four months). The measurement field includes: 1. Game activities (9 questions) 2. Skill development (15 questions) 3. Sports activities (10 questions) 4. Social activities (11 questions). The measurement aspect includes: diversity, intensity. There is moderate to good internal consistency.
Measured: baseline, up to 24hours,3-month FU
Functional Independence Measure for Children(WeeFIM)
It is used to understand the functional performance of children in the areas of self-care, mobility, and cognition. It is suitable for infants to adolescents. It contains 18 items, involving six functions. The score is from 1 to 7 points, 1 is completely dependent, and 7 is completely independent. Retest reliability and inter-tester reliability are 0.90-0.99.
Measured: baseline, up to 24hours,3-month FU
TNO-AZL Preschool children Quality of Life(TAPQOL)/TNO-AZL Quality of Life Questionnaire(TACQOL)
It is used to assess the health-related quality of life, such as children's motor, communication, emotions, and body structure. Suitable for children from 6 months to 6 years old (TAPQOL) and 6-15 years old (TACQOL). Parents fill in according to the child's condition. First, children or their parents check the frequency of the condition happening (1 ,means never, to 3 , means usually), then check how do children feel when the condition happens (0, means never, to 4 , means not very well).Higher score represent better outcome. Moderate to good retest reliability and inter-tester reliability.
Measured: baseline, up to 24hours,3-month FU
Sensory Profile(SP)
It is used to assess children's sensory processing capabilities, including sensory conditioning, emotional response, sensory processing, etc. Suitable for six-month old child to adults. It is a standardized evaluation tool, which is filled out by the main caregivers. The project score is 1-5 points, the internal consistency reliability is .70-.90, and the inter-tester reliability is .25-.76.
Measured: baseline, up to 24hours,3-month FU
Parenting Stress Index(PSI)
Used to understand parental distress, child distress behaviors and parent-child interaction. Suitable for parents of children under the age of 12. Parents fill in according to subjective feelings and current situation. This 1-5 point measure includes 3 subscales: Parent-Child Dysfunctional Interaction, Difficult Child, and Parent Distress. Higher percentile rank represent worse outcome. Retest reliability and inter-tester reliability is 0.89-0.93.
Measured: baseline, up to 24hours,3-month FU
Swanson, Nolan, and Pelham Questionnaire(SNAP)
It is used to measure the child's inattention, impulsivity or hyperactivity, as well as the status of opposing behavior. Fill in by parents or primary caregivers. This 0-3 point scale includes 26 items. Total scores range from 0 to 78. Higher scores represent a worse outcome. The retest reliability is 0.59-0.72, the internal consistency is 0.88-0.90, and the concurrent validity is 0.56-0.72.
Measured: baseline, up to 24hours,3-month FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Aug 2017
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ying Chung, MD, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994757
- Sponsor's protocol ID
- 201602004A3
- Status last verified
- Dec 2018
- First submitted
- 24 Dec 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Routines-Based Early Intervention in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03994757
- Acronym / sponsor ID
- 201602004A3
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Routine-Based Early Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRBI group | Experimental | Behavioral: MRBI |
| Control group | Sham comparator | Behavioral: Control |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parents are willing to sign written consent form
- Diagnosed as ASD by doctor
- No neurological disease
Key exclusion criteria (2 listed)
- Active medical condition
- Progressive or degenerative symptoms or illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRBIThe 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. | Behavioural | MRBI group |
| ControlTraditional 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. | Behavioural | Control group |
Primary outcome
Goal Attainment Scale(GAS)
Time frame: baseline, up to 24hours,3-month FU
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.
Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)
Time frame: baseline, up to 24hours,3-month FU
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.
14 secondary outcomes
Childhood Asperger Syndrome Test(CAST)
Time frame: baseline, up to 24hours,3-month FU
The Children Autism Rating Scale Second Edition(CARS-2)
Time frame: baseline, up to 24hours,3-month FU
Clancy Behavior Scale
Time frame: baseline, up to 24hours,3-month FU
Social Responsiveness Scale(SRS)
Time frame: baseline, up to 24hours,3-month FU
Theory of Mind Inventory-2(ToMI-2)
Time frame: baseline, up to 24hours,3-month FU
The Berry-Buktenica Developmental Test of Visual-Motor Integration(VMI)
Time frame: baseline, up to 24hours,3-month FU
Preschool Language Impaired Scale(PLS)/ Language Impaired Scale(LS)
Time frame: baseline, up to 24hours,3-month FU
Peabody Picture Vocabulary Test-Revised(PPVT-R)
Time frame: baseline, up to 24hours,3-month FU
Assessment of preschool children's participation(APCP) / Children Assessment of Participation and Enjoyment andPreferences for Activity of Children(CAPE)
Time frame: baseline, up to 24hours,3-month FU
Functional Independence Measure for Children(WeeFIM)
Time frame: baseline, up to 24hours,3-month FU
TNO-AZL Preschool children Quality of Life(TAPQOL)/TNO-AZL Quality of Life Questionnaire(TACQOL)
Time frame: baseline, up to 24hours,3-month FU
Sensory Profile(SP)
Time frame: baseline, up to 24hours,3-month FU
Parenting Stress Index(PSI)
Time frame: baseline, up to 24hours,3-month FU
Swanson, Nolan, and Pelham Questionnaire(SNAP)
Time frame: baseline, up to 24hours,3-month FU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ying Chung, MD study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRBI in people with Autism Spectrum Disorder, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Ying Chung, MD (+886-3-3281200 ext. 8148, chiaying928@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scale(GAS) (time frame: baseline, up to 24hours,3-month FU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.