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Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

interactive cognitive training

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring cognitive training, developmental delay, children, therapeutic effect

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

study group

control group

Arm Description

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.

3 months of traditional rehabilitation programs, without individualized interactive cognitive training.

Outcomes

Primary Outcome Measures

change of attention

score assessed by Swanson, Nolan and Pelham questionnaire

Secondary Outcome Measures

change of visual motor integration

score assessed by Beery-Buktenica Visual Motor Integration Test

change of sensory integration

score assessed by Sensory Profile questionnaire

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

change of functional performance

score assessed by Pediatric Outcome Data Collection Instrument

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

Full Information

NCT ID

NCT03632629

First Posted

July 13, 2018

Last Updated

August 13, 2018

Sponsor

Taipei Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03632629

Brief Title

Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 2018 (Anticipated)

Primary Completion Date

March 2019 (Anticipated)

Study Completion Date

March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

Keywords

cognitive training, developmental delay, children, therapeutic effect

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

study group

Arm Type

Active Comparator

Arm Description

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.

Arm Title

control group

Arm Type

No Intervention

Arm Description

3 months of traditional rehabilitation programs, without individualized interactive cognitive training.

Intervention Type

Other

Intervention Name(s)

interactive cognitive training

Intervention Description

Using interactive brain club system training to children with attention deficit hyperactivity disorder with developmental delay

Primary Outcome Measure Information:

Title

change of attention

Description

score assessed by Swanson, Nolan and Pelham questionnaire

Time Frame

scores change from baseline to 3 months of treatment, and 3 months after treatment

Secondary Outcome Measure Information:

Title

change of visual motor integration

Description

score assessed by Beery-Buktenica Visual Motor Integration Test

Time Frame

scores change from baseline to 3 months of treatment, and 3 months after treatment

Title

change of sensory integration

Description

score assessed by Sensory Profile questionnaire

Time Frame

scores change from baseline to 3 months of treatment, and 3 months after treatment

Title

change of intelligence

Description

Time Frame

scores change from baseline to 3 months of treatment, and 3 months after treatment

Title

change of functional performance

Description

score assessed by Pediatric Outcome Data Collection Instrument

Time Frame

changes from baseline to 3 months of treatment, and 3 months after treatment

Title

change of health-related quality of life

Description

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

Time Frame

changes from baseline to 3 months of treatment, and 3 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ru-Lan Hsieh, MD

Phone

+886228332211

Ext

2531

M001052@ms.skh.org.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Ru-Lan Hsieh, MD

Phone

+886228332211

Ext

2531

rulan1052@tmu.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ru-Lan Hsieh

Organizational Affiliation

Shin Kong Wu Ho-Su Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shin Kong Wu Ho-Su Memorial Hospital

City

Taipei

ZIP/Postal Code

111-01

Country

Taiwan

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ru-Lan Hsieh, MD

Phone

886-2-28332211

Ext

2538

rulan1052@tmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder

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