Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder

Not Applicable

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Other: interactive cognitive training

• Registration Number: NCT03632629
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Study First Submitted: 2018-07-13
• Status Verified: 2018-08
• Study Start: 2018-08
• Study First Submitted QC: 2018-08-13
• Last Update Submitted: 2018-08-13
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	interactive cognitive training	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.

Primary Outcome Measures

Name	Time	Method
change of attention	scores change from baseline to 3 months of treatment, and 3 months after treatment	score assessed by Swanson, Nolan and Pelham questionnaire

Secondary Outcome Measures

Name	Time	Method
change of sensory integration	scores change from baseline to 3 months of treatment, and 3 months after treatment	score assessed by Sensory Profile questionnaire
change of intelligence	scores change from baseline to 3 months of treatment, and 3 months after treatment	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 health-related quality of life	changes from baseline to 3 months of treatment, and 3 months after treatment	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
change of visual motor integration	scores change from baseline to 3 months of treatment, and 3 months after treatment	score assessed by Beery-Buktenica Visual Motor Integration Test
change of functional performance	changes from baseline to 3 months of treatment, and 3 months after treatment	score assessed by Pediatric Outcome Data Collection Instrument

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan