Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Developmental Delays; Attention Deficit Hyperactivity Disorders
• Intervention / Treatment: Other: cognitive training; Other: active control

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ru-Lan Hsieh, MD, MD; Phone Number: 2538, 2531 886-2-28332211; Email: M001052@ms.skh.org.tw
• Study Contact Backup: Name: Ru-Lan Hsieh, MD, MD; Email: rulanhsieh@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 111-01
    • Shin Kong Wu Ho-Su Memorial Hospital
    • Principal Investigator: Ru-Lan Hsieh, MD
    • Contact: Ru-Lan Hsieh, MD; Phone Number: 2538 886-2-28332211; Email: rulanhsieh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Traditional rehabilitation program with additional cognitive training	Other: cognitive training; cognitive training, 15 min, three times per week, for 12 weeks; Other Names: traditional rehabilitation programs
Other: Active Control; Traditional rehabilitation programs without additional cognitive training	Other: active control; Traditional rehabilitation programs; Other Names: traditional rehabilitation programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	score change from baseline to 12 weeks of treatment, higher score, the better outcome

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	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	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	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	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	score change from baseline to 12 weeks of treatment, higher score, the better outcome

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of brain network connectivity	Changes of brain network connectivity assessed by magnetoencephalography, range from 0-1, higher scores indicate a better outcome	connectivity change from baseline to 12 weeks of treatment, higher score, the better outcome

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: February 17, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: attention deficit hyperactivity disorder; preschool children; cognitive training; developmental delay
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: NSTC 112-2314-B-341-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No