Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03632629
• Other study ID #: 2018SKHADR028
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2018
• Est. completion date: March 2019

Study information

• Verified date: August 2018
• Source: Taipei Medical University
• Contact: Ru-Lan Hsieh, MD
• Phone: +886228332211
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

Other:
• interactive cognitive training
Using interactive brain club system training to children with attention deficit hyperactivity disorder with developmental delay

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
Primary	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	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
Secondary	change of sensory integration	score assessed by Sensory Profile questionnaire	scores change from baseline to 3 months of treatment, and 3 months after treatment
Secondary	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
Secondary	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
Secondary	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