Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays

NCT ID: NCT06277440

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Attention Deficit Hyperactivity Disorders Developmental Delays

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Intervention group

Traditional rehabilitation program with additional cognitive training

Group Type EXPERIMENTAL

cognitive training

Intervention Type OTHER

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

Active Control

Traditional rehabilitation programs without additional cognitive training

Group Type OTHER

active control

Intervention Type OTHER

Traditional rehabilitation programs

Interventions

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cognitive training

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

Intervention Type OTHER

active control

Traditional rehabilitation programs

Intervention Type OTHER

Other Intervention Names

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traditional rehabilitation programs traditional rehabilitation programs

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ru-Lan Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Ru-Lan Hsieh, MD, MD

Role: CONTACT

886-2-28332211 ext. 2538, 2531

Ru-Lan Hsieh, MD, MD

Role: CONTACT

Facility Contacts

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Ru-Lan Hsieh, MD

Role: primary

886-2-28332211 ext. 2538

Other Identifiers

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NSTC 112-2314-B-341-001

Identifier Type: -

Identifier Source: org_study_id

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