Autism Spectrum DisorderPDBINCT03812068
Parent-mediated Developmental Behavioral Intervention
A study testing Long-distance developmental behavioral intervention and Developmental behavioral intervention in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study explores the effectiveness of two intervention programs: "Long-distance developmental behavioral intervention" and "developmental behavioral interventions" for children with autism spectrum disorder or multiple developmental delays. Read more about this study
- Who is it for?
- Ages 30 months and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Long-distance developmental behavioral intervention and Developmental behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2018to 31 Aug 2021
- 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 30 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Child's age between 30-84 months old.
- Children have a diagnosis of autism spectrum disorder or multiple developmental delays.
- Children without physical disabilities or major health problems, such as congenital limb defects.
- One of the fathers or mothers involved in the study shall be the primary caregiver of the child.
- The father or mother participating in the study has at least 9 education years and can read and understand Chinese.
- The father or mother participating in the study is willing to allow the child to undergo a comprehensive development assessment and is willing to video during the training process.
Who cannot join
- Absence of chromosome abnormalities, congenital anomalies, and major neurological or sensory impairments or disorders (e.g., cerebral palsy, microcephalus, macrocephalus, severe brain damage, uncorrected vision, or hearing loss).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
School and Graduate Institute of Physical Therapy, National Taiwan University
Taipei, 100
Yen-Tzu Wu, PhD
About this study
Official title: The Effectiveness of a Parent-mediated Developmental Behavioral Intervention for Children With Autism Spectrum Disorder and Developmental Delay: A Randomized Controlled Trial
This study explores the effectiveness of two intervention programs: "Long-distance developmental behavioral intervention" and "developmental behavioral interventions" for children with autism spectrum disorder or multiple developmental delays.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Long-distance developmental behavioral intervention, Developmental behavioral intervention
- Keywords
- ASD, Early intervention, Development
- 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.
Long-distance developmental behavioral interventionBehavioural
Long-distance learning program combined parent-mediated developmental behavioral intervention
Developmental behavioral interventionBehavioural
Parent-mediated developmental behavioral intervention
| Study group | Role | What they receive |
|---|---|---|
| Long-distance developmental behavioral intervention | Experimental | Long-distance learning program combined parent-mediated developmental behavioral intervention Receives: Behavioral: Long-distance developmental behavioral intervention |
| Developmental behavioral intervention | Active comparator | only parent-mediated developmental behavioral intervention Receives: Behavioral: Developmental behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Autism Diagnostic Observation Schedule
measurement of autism status and severity level
Measured: 3 months
Child Behavior Checklist Ages 1.5-5
measurement of child's behavioral syndrome and problems
Measured: 3 months
Pediatric Evaluation of Disability Inventory
measurement of child's daily living function
Measured: 3 months
Mullen Scale of Early Learning
measurement of child's cognitive and motor development
Measured: 3 months
Movement Assessment Battery for Children
measurement of child's motor coordination
Measured: 3 months
3D Gait Assessment Foot-worn Inertial Sensor
measurement of gait performance
Measured: 3 months
Peabody Developmental Motor Scales, Second Edition
measurement of multiple fine and gross motor functions
Measured: 3 months
Secondary outcomes (2)
Parenting Stress Index
measurement of parenting stress for parents
Measured: 3 months
Parenting Sense of Competence Scale
measurement of the parent's self-efficacy and satisfaction as being parents
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start30 Sep 2018
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (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 National Taiwan University 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812068
- Sponsor's protocol ID
- 201809001RINC
- Acronym
- PDBI
- Status last verified
- Oct 2018
- First submitted
- 17 Jan 2019
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Parent-mediated Developmental Behavioral Intervention for Children With Autism Spectrum Disorder and Developmental Delay: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03812068
- Acronym / sponsor ID
- PDBI / 201809001RINC
- Conditions
- Autism Spectrum Disorder
- Keywords
- ASD, Early intervention, Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 22 Jan 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.
This study explores the effectiveness of two intervention programs: "Long-distance developmental behavioral intervention" and "developmental behavioral interventions" for children with autism spectrum disorder or multiple developmental delays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-distance developmental behavioral intervention | Experimental | Behavioral: Long-distance developmental behavioral interventionLong-distance learning program combined parent-mediated developmental behavioral intervention |
| Developmental behavioral intervention | Active comparator | Behavioral: Developmental behavioral interventiononly parent-mediated developmental behavioral intervention |
Who may qualify
- Ages
- 30 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Child's age between 30-84 months old.
- Children have a diagnosis of autism spectrum disorder or multiple developmental delays.
- Children without physical disabilities or major health problems, such as congenital limb defects.
- One of the fathers or mothers involved in the study shall be the primary caregiver of the child.
- The father or mother participating in the study has at least 9 education years and can read and understand Chinese.
Key exclusion criteria (1 listed)
- Absence of chromosome abnormalities, congenital anomalies, and major neurological or sensory impairments or disorders (e.g., cerebral palsy, microcephalus, macrocephalus, severe brain damage, uncorrected vision, or hearing loss).
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 |
|---|---|---|
| Long-distance developmental behavioral interventionLong-distance learning program combined parent-mediated developmental behavioral intervention | Behavioural | Long-distance developmental behavioral intervention |
| Developmental behavioral interventionParent-mediated developmental behavioral intervention | Behavioural | Developmental behavioral intervention |
Primary outcome
The Autism Diagnostic Observation Schedule
Time frame: 3 months
measurement of autism status and severity level
Child Behavior Checklist Ages 1.5-5
Time frame: 3 months
measurement of child's behavioral syndrome and problems
Pediatric Evaluation of Disability Inventory
Time frame: 3 months
measurement of child's daily living function
Mullen Scale of Early Learning
Time frame: 3 months
measurement of child's cognitive and motor development
Movement Assessment Battery for Children
Time frame: 3 months
measurement of child's motor coordination
3D Gait Assessment Foot-worn Inertial Sensor
Time frame: 3 months
measurement of gait performance
Peabody Developmental Motor Scales, Second Edition
Time frame: 3 months
measurement of multiple fine and gross motor functions
2 secondary outcomes
Parenting Stress Index
Time frame: 3 months
Parenting Sense of Competence Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-distance developmental behavioral intervention and Developmental behavioral intervention in people with Autism Spectrum Disorder, run by National Taiwan University 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 6 inclusion and 1 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 22 Jan 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. 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 Yen-Tzu Wu, PhD (886-2-33668136, yenwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Autism Diagnostic Observation Schedule (time frame: 3 months). The study lists 7 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 22 Jan 2019.