Developmental DelayNCT05502536
Effects of Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder
A study testing Traditional rehabilitation programs with Individualized fairytales class in people with Developmental Delay and Preschool Children, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Under traditional rehabilitation programs, investigate the additional effects of individualized fairytales on preschool children with Attention Deficit Hyperactivity Disorder with developmental delays. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Developmental Delay, Preschool Children, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Traditional rehabilitation programs with Individualized fairytales class
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Aug 2022to 30 Jun 2023
- 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 Attention Deficit Hyperactivity Disorder and 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 Attention Deficit Hyperactivity Disorder and developmental delay, under regular traditional rehabilitation programs, intelligence quotient below 70
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Individualized Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder With Developmental Delay
Under traditional rehabilitation programs, investigate the additional effects of individualized fairytales on preschool children with Attention Deficit Hyperactivity Disorder with developmental delays.
Read the detailed description
Thirty preschool children with Attention Deficit Hyperactivity Disorder and developmental delays will be enrolled in regular traditional rehabilitation programs.
They will be randomized to the intervention group and control group. The participants in the intervention group will receive an additional 30 minutes per week for 12 sessions of individualized fairytales classes by a child and educational teacher for three months. The participants of both groups will continue to receive the traditional rehabilitation programs.
Therapeutic effects, including attention, cognitive function, vocabulary function, physical functional performance, and quality of life at baseline, will be evaluated after 12 weeks of treatment and three months after the treatment.
The evaluator will be blinded to the group's allocation during the whole course of the intervention.
- Being tested
- Traditional rehabilitation programs with Individualized fairytales class
- Medical subject headings
- Learning Disabilities, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional rehabilitation programs with Individualized fairytales classOther
In addition to traditional rehabilitation programs, 30 minutes per week for 12 sessions of individualized fairytales classes by a child and educational teacher for three months, to preschool children with Attention Deficit Hyperactivity Disorder and developmental delays in regular traditional rehabilitation programs
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | traditional rehabilitation programs with additional individualized fairytales class Receives: Other: Traditional rehabilitation programs with Individualized fairytales class |
| Control group | No intervention | traditional rehabilitation programs without additional individualized fairytales class |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of hyperactivity
score assessed by Swanson, Nolan and Pelham questionnaire, higher score indicating greater hyperactivity
Measured: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
changes of attention
score change by Conners Kiddie Continuous Performance Test, greater score indicating lower attention span
Measured: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Secondary outcomes (10)
change of vocabulary
score change by Receptive and Expressive Vocabulary Test, higher score indicating greater performance
Measured: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of sensory integration
score change by Sensory Profile, 0-100, higher score indicating better sensory profile
Measured: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of intelligence
score change by Wechsler Intelligence Scale for Children, the average score is 100, with a higher score indicating higher intelligence and a lower score indicating a lower level of intelligence
Measured: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of physical functional performance
score assessed by Pediatric Outcome Data Collection Instrument, 0-100, a higher score indicating greater performance
Measured: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of quality of life
score assessed by the Pediatric Quality of Life Inventory, 0-100, a higher score indicating a greater quality of life
Measured: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of family impact
score assessed by Child Health Questionnaire, parent form 28, 0-100, a higher score indicating better performance
Measured: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of walking time
walking time
Measured: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of stairs climbing time
climbing time
Measured: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of balance
one leg standing time
Measured: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of physical function
5 times sit to stand up
Measured: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start20 Aug 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 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
- NCT05502536
- Sponsor's protocol ID
- 2022SKHADR033
- Status last verified
- Aug 2022
- First submitted
- 14 Aug 2022
- Last updated
- 16 Aug 2022
- 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 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Individualized Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder With Developmental Delay
- ClinicalTrials.gov ID
- NCT05502536
- Acronym / sponsor ID
- 2022SKHADR033
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 16 Aug 2022 (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.
Under traditional rehabilitation programs, investigate the additional effects of individualized fairytales on preschool children with Attention Deficit Hyperactivity Disorder with developmental delays.
Detailed description
Thirty preschool children with Attention Deficit Hyperactivity Disorder and developmental delays will be enrolled in regular traditional rehabilitation programs.
They will be randomized to the intervention group and control group. The participants in the intervention group will receive an additional 30 minutes per week for 12 sessions of individualized fairytales classes by a child and educational teacher for three months. The participants of both groups will continue to receive the traditional rehabilitation programs.
Therapeutic effects, including attention, cognitive function, vocabulary function, physical functional performance, and quality of life at baseline, will be evaluated after 12 weeks of treatment and three months after the treatment.
The evaluator 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
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Traditional rehabilitation programs with Individualized fairytales classtraditional rehabilitation programs with additional individualized fairytales class |
| Control group | No intervention | –traditional rehabilitation programs without additional individualized fairytales class |
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 Attention Deficit Hyperactivity Disorder and 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 Attention Deficit Hyperactivity Disorder and developmental delay, under regular traditional rehabilitation programs, intelligence quotient below 70
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 |
|---|---|---|
| Traditional rehabilitation programs with Individualized fairytales classIn addition to traditional rehabilitation programs, 30 minutes per week for 12 sessions of individualized fairytales classes by a child and educational teacher for three months, to preschool children with Attention Deficit Hyperactivity Disorder and developmental delays in regular traditional rehabilitation programs | Other | Intervention group |
Primary outcome
changes of hyperactivity
Time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
score assessed by Swanson, Nolan and Pelham questionnaire, higher score indicating greater hyperactivity
changes of attention
Time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
score change by Conners Kiddie Continuous Performance Test, greater score indicating lower attention span
10 secondary outcomes
change of vocabulary
Time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of sensory integration
Time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of intelligence
Time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of physical functional performance
Time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of quality of life
Time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of family impact
Time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of walking time
Time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of stairs climbing time
Time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of balance
Time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
change of physical function
Time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- 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 Traditional rehabilitation programs with Individualized fairytales class in people with Developmental Delay and Preschool Children, 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 16 Aug 2022. 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 (886-2-28332211 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 hyperactivity (time frame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment). 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 16 Aug 2022.