Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder

Treatment Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder and Developmental Delay

Using a single blind, randomized controlled design to study the additional therapeutic effects of cognitive training on traditional rehabilitation programs for children with attention deficit hyperactivity disorder and developmental delays.

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: interactive cognitive training

Detailed Description

A total of 30 children with attention deficit hyperactivity disorder and developmental delays who are receiving traditional rehabilitation programs will be enrolled.

The participants will be randomized into two groups, including study group (traditional rehabilitation program with additional cognitive training: 2 times per week, 15 min per session, a total of 24 sessions) and control group (traditional rehabilitation program without additional cognitive training).

Memory related functions, quality of life, and physical function evaluations will be performed at baseline, 3 months and 6 months later, respectively.

Evaluator will be blinded to the group's classification during the whole course of study.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ru-Lan Hsieh, MD; Phone Number: 2531 +886228332211; Email: M001052@ms.skh.org.tw
• Study Contact Backup: Name: Ru-Lan Hsieh, MD; Phone Number: 2531 +886228332211; Email: rulan1052@tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 111-01
    • Shin Kong Wu Ho-Su Memorial Hospital
    • Contact: Ru-Lan Hsieh, MD; Phone Number: 2538 886-2-28332211; Email: rulan1052@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children diagnosed with attention deficit hyperactivity disorder with developmental delay receiving regular rehabilitation programs intelligence quotient 70 or greater

Exclusion Criteria:

• age less than 4 years or elder than 8 years children diagnosed with attention deficit hyperactivity disorder receiving regular rehabilitation programs intelligence quotient less than 70

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study group; 3 months of individualized interactive cognitive training, 2 times per week, 15 min per session, a total of 24 sessions, in addition to traditional rehabilitation programs.	Other: interactive cognitive training; Using interactive brain club system training to children with attention deficit hyperactivity disorder with developmental delay
No Intervention: control group; 3 months of traditional rehabilitation programs, without individualized interactive cognitive training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of attention	score assessed by Swanson, Nolan and Pelham questionnaire	scores change from baseline to 3 months of treatment, and 3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of visual motor integration	score assessed by Beery-Buktenica Visual Motor Integration Test	scores change from baseline to 3 months of treatment, and 3 months after treatment
change of sensory integration	score assessed by Sensory Profile questionnaire	scores change from baseline to 3 months of treatment, and 3 months after treatment
change of intelligence	score assessed by Wechsler Intelligence Scale for Children, including verbal, performance and total scores, the average score is 100, with higher scores indicating higher than average intelligence and lower scores indicating lower levels of intelligence	scores change from baseline to 3 months of treatment, and 3 months after treatment
change of functional performance	score assessed by Pediatric Outcome Data Collection Instrument	changes from baseline to 3 months of treatment, and 3 months after treatment
change of health-related quality of life	score assessed by Pediatric Quality of Life Inventory-Generic Core Scales, including physical, psychosocial, and total scores, with higher scores representing better health-related quality of life	changes from baseline to 3 months of treatment, and 3 months after treatment

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: children; cognitive training; developmental delay; therapeutic effect
• 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: 2018SKHADR028

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