Attention Deficit Hyperactivity DisorderNCT04375059
Effects of Attention Training on Children
A study testing using interactive attention training system in people with Attention Deficit Hyperactivity Disorder, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Using a double-blind, randomized controlled design to investigate the therapeutic effects of interactive attention training for children with Attention Deficit Hyperactivity Disorder who are receiving conventional rehabilitation programs due to developmental delay. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- using interactive attention training system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2020to 31 Dec 2020
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater
Who cannot join
- age less than 4 or greater than 8 of children diagnosed with Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient less than 70
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Effects of Interactive Attention Training on Children With Attention Deficit Hyperactivity Disorder
Using a double-blind, randomized controlled design to investigate the therapeutic effects of interactive attention training for children with Attention Deficit Hyperactivity Disorder who are receiving conventional rehabilitation programs due to developmental delay.
Read the detailed description
A total of 30 children with Attention Deficit Hyperactivity Disorder conducting conventional rehabilitation programs well be enrolled.
The children are randomized into two groups, including study group with conventional rehabilitation programs and interactive attention training: 2 times per week, 15 min per session, with a total of 24 sessions in 3 months; and control group with conventional rehabilitation programs without interactive attention training.
Therapeutic effects, including working memory, attention, functional performance, physical function, health-related quality of life will be evaluated at baseline, and 3 months and 6 months after the intervention.
The evaluator and children will be blinded to the group's allocation during the whole course of the intervention.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- using interactive attention training system
- Keywords
- attention training, children, therapeutic effects, developmental delay
- 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.
using interactive attention training systemOther
using the interactive attention training system to children with Attention Deficit Hyperactivity Disorder
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | 3 months of interactive attention training programs, 2 times per week, 15 min per session, a total of 24 sessions, with conventional rehabilitation programs Receives: Other: using interactive attention training system |
| Control group | No intervention | 3 months of conventional rehabilitation programs without interactive attention training programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of symptoms of attention deficit hyperactivity disorder
score assessed by Swanson, Nolan and Pelham questionnaire
Measured: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
Secondary outcomes (12)
changes of sensory integration
score assessed by Sensory Profile
Measured: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of visual motor integration
score assessed by Beery-Buktenica Visual Motor Integration Test
Measured: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of intelligence
score assessed by Wechsler Intelligence Scale for Children
Measured: score change from baseline to 3 months 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 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of health-related quality of life
score assessed by Pediatric Quality of Life Inventory
Measured: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of family impact
Child Health Questionnaire, parent form 28
Measured: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of walking speed
walking speed
Measured: time change from baseline to 3 months of treatment, and 3 months after treatment
changes of chair climbing speed
stairs climbing speed
Measured: time change from baseline to 3 months of treatment, and 3 months after treatment
changes of balance
one leg standing time
Measured: time change from baseline to 3 months of treatment, and 3 months after treatment
changes of coordination
Berg Balance Scale
Measured: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of balance and coordination
timed up and go test
Measured: time change from baseline to 3 months of treatment, and 3 months after treatment
changes of physical performance
5 time sit to stand test
Measured: time change from baseline to 3 months of treatment, and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 May 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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 DisorderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Ru-Lan, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375059
- Sponsor's protocol ID
- 2019SKHADR038
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 5 May 2020
- 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 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Interactive Attention Training on Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT04375059
- Acronym / sponsor ID
- 2019SKHADR038
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- attention training, children, therapeutic effects, developmental delay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 May 2020 (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 double-blind, randomized controlled design to investigate the therapeutic effects of interactive attention training for children with Attention Deficit Hyperactivity Disorder who are receiving conventional rehabilitation programs due to developmental delay.
Detailed description
A total of 30 children with Attention Deficit Hyperactivity Disorder conducting conventional rehabilitation programs well be enrolled.
The children are randomized into two groups, including study group with conventional rehabilitation programs and interactive attention training: 2 times per week, 15 min per session, with a total of 24 sessions in 3 months; and control group with conventional rehabilitation programs without interactive attention training.
Therapeutic effects, including working memory, attention, functional performance, physical function, health-related quality of life will be evaluated at baseline, and 3 months and 6 months after the intervention.
The evaluator and children 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Other: using interactive attention training system3 months of interactive attention training programs, 2 times per week, 15 min per session, a total of 24 sessions, with conventional rehabilitation programs |
| Control group | No intervention | –3 months of conventional rehabilitation programs without interactive attention training programs |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater
Key exclusion criteria (1 listed)
- age less than 4 or greater than 8 of children diagnosed with Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, 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 |
|---|---|---|
| using interactive attention training systemusing the interactive attention training system to children with Attention Deficit Hyperactivity Disorder | Other | Study group |
Primary outcome
changes of symptoms of attention deficit hyperactivity disorder
Time frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
score assessed by Swanson, Nolan and Pelham questionnaire
12 secondary outcomes
changes of sensory integration
Time frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of visual motor integration
Time frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of intelligence
Time frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of functional performance
Time frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of health-related quality of life
Time frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of family impact
Time frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of walking speed
Time frame: time change from baseline to 3 months of treatment, and 3 months after treatment
changes of chair climbing speed
Time frame: time change from baseline to 3 months of treatment, and 3 months after treatment
changes of balance
Time frame: time change from baseline to 3 months of treatment, and 3 months after treatment
changes of coordination
Time frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of balance and coordination
Time frame: time change from baseline to 3 months of treatment, and 3 months after treatment
changes of physical performance
Time frame: time change from baseline to 3 months of treatment, and 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- 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 Ru-Lan, 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 using interactive attention training system in people with Attention Deficit Hyperactivity Disorder, 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 5 May 2020. 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 symptoms of attention deficit hyperactivity disorder (time frame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a 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 5 May 2020.