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Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays

Cognitive Training Effects for Preschool Children With Attention Deficit Hyperactivity Disorder and Developmental Delays

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06277440
Enrollment
20
Registered
2024-02-26
Start date
2024-03-01
Completion date
2024-09-30
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorders, Developmental Delays

Keywords

preschool children, developmental delay, cognitive training, attention deficit hyperactivity disorder

Brief 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. 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.

Interventions

OTHERcognitive training

cognitive training, 15 min, three times per week, for 12 weeks

OTHERactive control

Traditional rehabilitation programs

Sponsors

Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome measurements will be performed by a researcher who is blind to the groups' allocation.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

* preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under regular rehabilitation programs intelligence quotient 70 or greater

Exclusion criteria

* age less than 4 or greater than 6 metal in teeth intelligence quotient less than 70

Design outcomes

Primary

MeasureTime frameDescription
Changes of executive functionscore change from baseline to 12 weeks of treatment, higher score, the better outcomeChanges in scores assessed by the Taiwanese Traditional Chinese Childhood Executive Functioning Inventory range from 1 to 5, higher scores indicate a worse outcome

Secondary

MeasureTime frameDescription
changes of symptoms of attention deficit hyperactivity disorderscore change from baseline to 12 weeks of treatment, higher score, the better outcomeChanges in scores assessed by Swanson, Nolan and Pelham questionnaire, range from 0 to 54, higher scores indicate a worse outcome
changes of attentionscore change from baseline to 12 weeks of treatment, higher score, the better outcomeChanges in scores assessed by Conners Kiddie Continous Performance Test, range from 0-100, higher scores indicate a worse outcome
Changes of sensory integrationscore change from baseline to 12 weeks of treatment, higher score, the better outcomeChanges in scores assessed by Sensory Profile, range from 0-100, higher scores indicate a better outcome
changes of intelligencescore change from baseline to 12 weeks of treatment, higher score, the better outcomeChanges 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.
Changes of family impactscore change from baseline to 12 weeks of treatment, higher score, the better outcomeChanges in scores assessed by Child Health Questionaire, parent form 28, range from 0-100, higher scores indicate a better outcome
Changes of quality of lifescore change from baseline to 12 weeks of treatment, higher score, the better outcomeChanges in scores assessed by Pediatric Quality of Life Inventory, range from 0-100, higher scores indicate a better outcome
Changes in performance activity in kindergartenscore change from baseline to 12 weeks of treatment, higher score, the better outcomeChanges in scores assessed by Kindergarten Performance Activity, range from 0-100, higher scores indicate a worse outcome
changes of functional performancescore change from baseline to 12 weeks of treatment, higher score, the better outcomeChanges in scores assessed by Pediatric Outcome Data Collection Instrument, range from 0-100, higher scores indicate a better outcome

Other

MeasureTime frameDescription
changes of brain network connectivityconnectivity change from baseline to 12 weeks of treatment, higher score, the better outcomeChanges of brain network connectivity assessed by magnetoencephalography, range from 0-1, higher scores indicate a better outcome

Countries

Taiwan

Contacts

Primary ContactRu-Lan Hsieh, MD, MD
M001052@ms.skh.org.tw886-2-28332211
Backup ContactRu-Lan Hsieh, MD, MD
rulanhsieh@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026