Developmental DelayNCT04988139
Effects of Educational Training on Children With Developmental Delay
A study testing individualized educational training in people with Developmental Delay, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Using a single-blind, randomized controlled design to investigate the additional therapeutic effects of individualized educational training on traditional rehabilitation programs for preschool children with developmental delays. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Developmental Delay
- What is being tested?
- individualized educational training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 31 Dec 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preschool children with a diagnosis of developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
Who cannot join
- age less than 3 or greater than 6 of children diagnosed with developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effects of Individualized Educational Training on Preschool Children With Global Developmental Delay
Using a single-blind, randomized controlled design to investigate the additional therapeutic effects of individualized educational training on traditional rehabilitation programs for preschool children with developmental delays.
Read the detailed description
A total of 20 preschool children with developmental delay who are receiving traditional rehabilitation programs will be enrolled.
The participants will be randomized into two groups, including the intervention group (traditional rehabilitation program with individualized educational training: one time per week, 50 min per session, with a total of 4 sessions in one month) and the control group (traditional rehabilitation program without individualized educational training).
Therapeutic effects, including pediatric daily activity, attention, cognitive function, functional performance, quality of life, and physical functional performance at baseline, after one month of treatment, and 3 months after the treatment, will be evaluated.
The evaluators will be blinded to the group's allocation during the whole course of the intervention.
- Conditions
- Developmental Delay
- Being tested
- individualized educational training
- Keywords
- preschool children, developmental delay, educational training, therapeutic effects
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized educational trainingOther
50 min per session, one session per week, 4 sessions per month, of individualized educational training to preschool children with developmental delays under traditional rehabilitation programs
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | traditional rehabilitation programs with additional individualized educational training Receives: Other: individualized educational training |
| Control group | No intervention | traditional rehabilitation programs without additional individualized educational training |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of daily activity
score assessed by Pediatric Daily Occupation Scale
Measured: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of attention
score assessed by Conners Kiddie Continous Performance Test, 2nd edition
Measured: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Secondary outcomes (10)
change of visual motor integration
score assessed by Beery-Buktenica Visual Motor Integration
Measured: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
change of intelligence
score assessed by Wechsler Intelligence Scale of children
Measured: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Changes of functional performance
score assessed by Pediatric Outcome Data Collection Instrument
Measured: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of quality of life
score assessed by Pediatric Quality of Life Inventory
Measured: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of family impact
score assessed by Child Health Questionnaire, parent form 28
Measured: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of walking speed
walking speed
Measured: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of chair climbing speed
stairs climbing speed
Measured: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of balance
one leg standing time
Measured: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of balance and coordination
timed up and go test
Measured: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of physical function
5 times sit to stand test
Measured: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DelayStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Model description
- A total of 20 children with developmental delays who are receiving traditional rehabilitation programs will be enrolled. The participants will be randomized into two groups, including the intervention group (traditional rehabilitation program with additional educational training) and the control group (traditional rehabilitation program without educational training). The intervention group will receive 1 month of individualized educational training, 50 min per session, 1 session per week, a total of 4 sessions. All of the evaluations will be performed before training, re-evaluated 1 month after completion of treatment, and 3 months after completion of the treatment in the study group. The control group will be evaluated at the baseline, 1 month, and 6 months later, respectively.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ru-Lan Hsieh, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988139
- Sponsor's protocol ID
- 2021SKHADR032
- Status last verified
- Jul 2021
- First submitted
- 31 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Individualized Educational Training on Preschool Children With Global Developmental Delay
- ClinicalTrials.gov ID
- NCT04988139
- Acronym / sponsor ID
- 2021SKHADR032
- Conditions
- Developmental Delay
- Keywords
- preschool children, developmental delay, educational training, therapeutic effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Aug 2021 (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.
Using a single-blind, randomized controlled design to investigate the additional therapeutic effects of individualized educational training on traditional rehabilitation programs for preschool children with developmental delays.
Detailed description
A total of 20 preschool children with developmental delay who are receiving traditional rehabilitation programs will be enrolled.
The participants will be randomized into two groups, including the intervention group (traditional rehabilitation program with individualized educational training: one time per week, 50 min per session, with a total of 4 sessions in one month) and the control group (traditional rehabilitation program without individualized educational training).
Therapeutic effects, including pediatric daily activity, attention, cognitive function, functional performance, quality of life, and physical functional performance at baseline, after one month of treatment, and 3 months after the treatment, will be evaluated.
The evaluators will be blinded to the group's allocation during the whole course of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 20 children with developmental delays who are receiving traditional rehabilitation programs will be enrolled. The participants will be randomized into two groups, including the intervention group (traditional rehabilitation program with additional educational training) and the control group (traditional rehabilitation program without educational training). The intervention group will receive 1 month of individualized educational training, 50 min per session, 1 session per week, a total of 4 sessions. All of the evaluations will be performed before training, re-evaluated 1 month after completion of treatment, and 3 months after completion of the treatment in the study group. The control group will be evaluated at the baseline, 1 month, and 6 months later, respectively.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: individualized educational trainingtraditional rehabilitation programs with additional individualized educational training |
| Control group | No intervention | –traditional rehabilitation programs without additional individualized educational training |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preschool children with a diagnosis of developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
Key exclusion criteria (1 listed)
- age less than 3 or greater than 6 of children diagnosed with developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
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 |
|---|---|---|
| individualized educational training50 min per session, one session per week, 4 sessions per month, of individualized educational training to preschool children with developmental delays under traditional rehabilitation programs | Other | Intervention group |
Primary outcome
changes of daily activity
Time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
score assessed by Pediatric Daily Occupation Scale
changes of attention
Time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
score assessed by Conners Kiddie Continous Performance Test, 2nd edition
10 secondary outcomes
change of visual motor integration
Time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
change of intelligence
Time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Changes of functional performance
Time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of quality of life
Time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of family impact
Time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of walking speed
Time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of chair climbing speed
Time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of balance
Time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of balance and coordination
Time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of physical function
Time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- 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.
Ru-Lan Hsieh, MD principal investigator
Shin Kong Wu Ho-Su 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 individualized educational training in people with Developmental Delay, run by Taipei Medical University 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 1 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 3 Aug 2021. 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 Ru-Lan Hsieh, MD (886228332211 ext. 2531, M001052@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of daily activity (time frame: score change from baseline to 1 month of treatment, and 3 months after treatment, lower scores mean a worse outcome). 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 3 Aug 2021.