Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays

Developmental Delays Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06277440
• Other study ID #: NSTC 112-2314-B-341-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Taipei Medical University
• Contact: Ru-Lan Hsieh, MD, MD
• Phone: 886-2-28332211
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorders
• Developmental Delays
• Hyperkinesis

Intervention

Other:
• cognitive training
cognitive training, 15 min, three times per week, for 12 weeks
• active control
Traditional rehabilitation programs

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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