Back to resultsEffects of Attention Training on Children
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
using interactive attention training system
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring attention training, children, therapeutic effects, developmental delay
Eligibility Criteria
Inclusion Criteria:
- children with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater
Exclusion Criteria:
- 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
Sites / Locations
- Shin Kong Wu Ho-Su Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Study group
Control group
Arm Description
3 months of interactive attention training programs, 2 times per week, 15 min per session, a total of 24 sessions, with conventional rehabilitation programs
3 months of conventional rehabilitation programs without interactive attention training programs
Outcomes
Primary Outcome Measures
changes of symptoms of attention deficit hyperactivity disorder
score assessed by Swanson, Nolan and Pelham questionnaire
Secondary Outcome Measures
changes of sensory integration
score assessed by Sensory Profile
changes of visual motor integration
score assessed by Beery-Buktenica Visual Motor Integration Test
changes of intelligence
score assessed by Wechsler Intelligence Scale for Children
changes of functional performance
score assessed by Pediatric Outcome Data Collection Instrument
changes of health-related quality of life
score assessed by Pediatric Quality of Life Inventory
changes of family impact
Child Health Questionnaire, parent form 28
changes of walking speed
walking speed
changes of chair climbing speed
stairs climbing speed
changes of balance
one leg standing time
changes of coordination
Berg Balance Scale
changes of balance and coordination
timed up and go test
changes of physical performance
5 time sit to stand test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04375059
Brief Title
Effects of Attention Training on Children
Official Title
Therapeutic Effects of Interactive Attention Training on Children With Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
attention training, children, therapeutic effects, developmental delay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
3 months of interactive attention training programs, 2 times per week, 15 min per session, a total of 24 sessions, with conventional rehabilitation programs
Arm Title
Control group
Arm Type
No Intervention
Arm Description
3 months of conventional rehabilitation programs without interactive attention training programs
Intervention Type
Other
Intervention Name(s)
using interactive attention training system
Intervention Description
using the interactive attention training system to children with Attention Deficit Hyperactivity Disorder
Primary Outcome Measure Information:
Title
changes of symptoms of attention deficit hyperactivity disorder
Description
score assessed by Swanson, Nolan and Pelham questionnaire
Time Frame
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
Secondary Outcome Measure Information:
Title
changes of sensory integration
Description
score assessed by Sensory Profile
Time Frame
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
Title
changes of visual motor integration
Description
score assessed by Beery-Buktenica Visual Motor Integration Test
Time Frame
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
Title
changes of intelligence
Description
score assessed by Wechsler Intelligence Scale for Children
Time Frame
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
Title
changes of functional performance
Description
score assessed by Pediatric Outcome Data Collection Instrument
Time Frame
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
Title
changes of health-related quality of life
Description
score assessed by Pediatric Quality of Life Inventory
Time Frame
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
Title
changes of family impact
Description
Child Health Questionnaire, parent form 28
Time Frame
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
Title
changes of walking speed
Description
walking speed
Time Frame
time change from baseline to 3 months of treatment, and 3 months after treatment
Title
changes of chair climbing speed
Description
stairs climbing speed
Time Frame
time change from baseline to 3 months of treatment, and 3 months after treatment
Title
changes of balance
Description
one leg standing time
Time Frame
time change from baseline to 3 months of treatment, and 3 months after treatment
Title
changes of coordination
Description
Berg Balance Scale
Time Frame
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
Title
changes of balance and coordination
Description
timed up and go test
Time Frame
time change from baseline to 3 months of treatment, and 3 months after treatment
Title
changes of physical performance
Description
5 time sit to stand test
Time Frame
time change from baseline to 3 months of treatment, and 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
children with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ru-Lan Hsieh, MD
Phone
886228332211
Ext
2531
Email
M001052@ms.skh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ru-Lan Ru-Lan, MD
Phone
886228332211
Ext
2531
Email
M001052@ms.skh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Lan Ru-Lan, MD
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111-01
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Attention Training on Children
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