Attention Deficit Hyperactivity DisordersNCT06277440
Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays
A study testing cognitive training in people with Attention Deficit Hyperactivity Disorders and Developmental Delays, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
To explore whether children with Attention Deficit Hyperactivity Disorder and developmental delays who receive cognitive training and conventional rehabilitation can improve executive function more than traditional rehabilitation alone. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorders, Developmental Delays
- What is being tested?
- cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2024to 30 Sep 2024
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under regular rehabilitation programs intelligence quotient 70 or greater
Who cannot join
- age less than 4 or greater than 6 metal in teeth intelligence quotient less than 70
Trial locations and contacts
1 site in 1 country.
Ru-Lan Hsieh, MD, MD contact
Taiwan1 site
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111-01
Ru-Lan Hsieh, MD, 886-2-28332211 ext. 2538, rulanhsieh@gmail.com
Ru-Lan Hsieh, MD
About this study
Official title: Cognitive Training Effects for Preschool Children With Attention Deficit Hyperactivity Disorder and Developmental Delays
To explore whether children with Attention Deficit Hyperactivity Disorder and developmental delays who receive cognitive training and conventional rehabilitation can improve executive function more than traditional rehabilitation alone. A magnetoencephalographic examination will be arranged to explore how brain network activation works.
Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated.
Read the detailed description
Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated, including Sensory Profile, Swanson, Nolan and Pelham version IV, Conners Kiddie Continuous Performance test, Chinese Childhood Executive Functioning Inventory, and Chinese version of Wechsler Intelligence Scale for Children-IV; and physical health conditions, including Pediatric Daily Occupation Scale, Pediatric Outcome Data Collection Instrument (PODCI), Child Health Questionnaire- Parent Form, Pediatric Quality of Life Inventory (PedsQL)will be evaluated by an investigator who is blinded to the group's allocation at before treatment and after 12 weeks of treatment. All participants will be investigated by magnetoencephalography (MEG) to identify the brain network connectivity while performing different tasks before and after 12 weeks of treatment. Brain Magnetic Resonance Imaging will be performed for brain mapping.
Possible results: The study will shed light on therapeutic effects and brain network connectivity by cognitive training for preschool children with Attention Deficit Hyperactivity Disorder and developmental delays.
- Being tested
- cognitive training, active control
- Keywords
- preschool children, developmental delay, cognitive training, attention deficit hyperactivity disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive trainingOther
Also called traditional rehabilitation programs
cognitive training, 15 min, three times per week, for 12 weeks
active controlOther
Also called traditional rehabilitation programs
Traditional rehabilitation programs
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Traditional rehabilitation program with additional cognitive training Receives: Other: cognitive training |
| Active Control | Other | Traditional rehabilitation programs without additional cognitive training Receives: Other: active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of executive function
Changes in scores assessed by the Taiwanese Traditional Chinese Childhood Executive Functioning Inventory range from 1 to 5, higher scores indicate a worse outcome
Measured: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Secondary outcomes (8)
changes of symptoms of attention deficit hyperactivity disorder
Changes in scores assessed by Swanson, Nolan and Pelham questionnaire, range from 0 to 54, higher scores indicate a worse outcome
Measured: score change from baseline to 12 weeks of treatment, higher score, the better outcome
changes of attention
Changes in scores assessed by Conners Kiddie Continous Performance Test, range from 0-100, higher scores indicate a worse outcome
Measured: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Changes of sensory integration
Changes in scores assessed by Sensory Profile, range from 0-100, higher scores indicate a better outcome
Measured: score change from baseline to 12 weeks of treatment, higher score, the better outcome
changes of intelligence
Changes in scores assessed by the Wechsler Intelligence Scale of 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, higher score, the better outcome
changes of functional performance
Changes in scores assessed by Pediatric Outcome Data Collection Instrument, range from 0-100, higher scores indicate a better outcome
Measured: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Changes of family impact
Changes in scores assessed by Child Health Questionaire, parent form 28, range from 0-100, higher scores indicate a better outcome
Measured: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Changes of quality of life
Changes in scores assessed by Pediatric Quality of Life Inventory, range from 0-100, higher scores indicate a better outcome
Measured: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Changes in performance activity in kindergarten
Changes in scores assessed by Kindergarten Performance Activity, range from 0-100, higher scores indicate a worse outcome
Measured: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisordersStudies of the same condition, open and under way.
- 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
- Twenty preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated by an investigator blinded to the group's allocation before and after 12 weeks of treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 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
- NCT06277440
- Sponsor's protocol ID
- NSTC 112-2314-B-341-001
- Status last verified
- Feb 2024
- First submitted
- 5 Jan 2024
- Last updated
- 26 Feb 2024
- 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 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training Effects for Preschool Children With Attention Deficit Hyperactivity Disorder and Developmental Delays
- ClinicalTrials.gov ID
- NCT06277440
- Acronym / sponsor ID
- NSTC 112-2314-B-341-001
- Keywords
- preschool children, developmental delay, cognitive training, attention deficit hyperactivity disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 26 Feb 2024 (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.
To explore whether children with Attention Deficit Hyperactivity Disorder and developmental delays who receive cognitive training and conventional rehabilitation can improve executive function more than traditional rehabilitation alone. A magnetoencephalographic examination will be arranged to explore how brain network activation works.
Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated.
Detailed description
Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated, including Sensory Profile, Swanson, Nolan and Pelham version IV, Conners Kiddie Continuous Performance test, Chinese Childhood Executive Functioning Inventory, and Chinese version of Wechsler Intelligence Scale for Children-IV; and physical health conditions, including Pediatric Daily Occupation Scale, Pediatric Outcome Data Collection Instrument (PODCI), Child Health Questionnaire- Parent Form, Pediatric Quality of Life Inventory (PedsQL)will be evaluated by an investigator who is blinded to the group's allocation at before treatment and after 12 weeks of treatment. All participants will be investigated by magnetoencephalography (MEG) to identify the brain network connectivity while performing different tasks before and after 12 weeks of treatment. Brain Magnetic Resonance Imaging will be performed for brain mapping.
Possible results: The study will shed light on therapeutic effects and brain network connectivity by cognitive training for preschool children with Attention Deficit Hyperactivity Disorder and developmental delays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Twenty preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated by an investigator blinded to the group's allocation before and after 12 weeks of treatment.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: cognitive trainingTraditional rehabilitation program with additional cognitive training |
| Active Control | Other | Other: active controlTraditional rehabilitation programs without additional cognitive training |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under regular rehabilitation programs intelligence quotient 70 or greater
Key exclusion criteria (1 listed)
- age less than 4 or greater than 6 metal in teeth intelligence quotient less than 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 |
|---|---|---|
| cognitive trainingAlso: traditional rehabilitation programscognitive training, 15 min, three times per week, for 12 weeks | Other | Intervention group |
| active controlAlso: traditional rehabilitation programsTraditional rehabilitation programs | Other | Active Control |
Primary outcome
Changes of executive function
Time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Changes in scores assessed by the Taiwanese Traditional Chinese Childhood Executive Functioning Inventory range from 1 to 5, higher scores indicate a worse outcome
8 secondary outcomes
changes of symptoms of attention deficit hyperactivity disorder
Time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
changes of attention
Time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Changes of sensory integration
Time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
changes of intelligence
Time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
changes of functional performance
Time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Changes of family impact
Time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Changes of quality of life
Time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Changes in performance activity in kindergarten
Time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- 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, MD contact
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 cognitive training in people with Attention Deficit Hyperactivity Disorders and Developmental Delays, 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 26 Feb 2024. 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, MD (886-2-28332211 ext. 2538, 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 executive function (time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome). 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 26 Feb 2024.