Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays

NCT06277440 | Not Yet Recruiting

• 1 other identifier: NSTC 112-2314-B-341-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorders; Developmental Delays

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• changes of symptoms of attention deficit hyperactivity disorder

  score change from baseline to 12 weeks of treatment, higher score, the better outcome

• changes of attention

  score change from baseline to 12 weeks of treatment, higher score, the better outcome

• Changes of sensory integration

  score change from baseline to 12 weeks of treatment, higher score, the better outcome

• changes of intelligence

  score change from baseline to 12 weeks of treatment, higher score, the better outcome

• changes of functional performance

  score change from baseline to 12 weeks of treatment, higher score, the better outcome

Other Outcomes (1)

• changes of brain network connectivity

  connectivity change from baseline to 12 weeks of treatment, higher score, the better outcome

Study Arms (2)

Intervention group

EXPERIMENTAL

Traditional rehabilitation program with additional cognitive training

Other: cognitive training

Active Control

OTHER

Traditional rehabilitation programs without additional cognitive training

Other: active control

Interventions

cognitive training OTHER

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

Also known as: traditional rehabilitation programs

Intervention group

active control OTHER

Traditional rehabilitation programs

Also known as: traditional rehabilitation programs

Active Control

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Learning Disabilities

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ru-Lan Hsieh, MD

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Lan Hsieh, MD, MD

CONTACT

886-2-28332211; M001052@ms.skh.org.tw

Ru-Lan Hsieh, MD, MD

CONTACT

rulanhsieh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measurements will be performed by a researcher who is blind to the groups' allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 26, 2024
• Study Start: March 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)