Effects of Attention Training on Children

Therapeutic Effects of Interactive Attention Training on Children With Attention Deficit Hyperactivity Disorder

Using a double-blind, randomized controlled design to investigate the therapeutic effects of interactive attention training for children with Attention Deficit Hyperactivity Disorder who are receiving conventional rehabilitation programs due to developmental delay.

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: using interactive attention training system

Detailed Description

A total of 30 children with Attention Deficit Hyperactivity Disorder conducting conventional rehabilitation programs well be enrolled.

The children are randomized into two groups, including study group with conventional rehabilitation programs and interactive attention training: 2 times per week, 15 min per session, with a total of 24 sessions in 3 months; and control group with conventional rehabilitation programs without interactive attention training.

Therapeutic effects, including working memory, attention, functional performance, physical function, health-related quality of life will be evaluated at baseline, and 3 months and 6 months after the intervention.

The evaluator and children will be blinded to the group's allocation during the whole course of the intervention.

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

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 111-01
    • Shin Kong Wu Ho-Su Memorial Hospital

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 with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater

Exclusion Criteria:

• age less than 4 or greater than 8 of children diagnosed with Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional 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: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study group; 3 months of interactive attention training programs, 2 times per week, 15 min per session, a total of 24 sessions, with conventional rehabilitation programs	Other: using interactive attention training system; using the interactive attention training system to children with Attention Deficit Hyperactivity Disorder
No Intervention: Control group; 3 months of conventional rehabilitation programs without interactive attention training programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of symptoms of attention deficit hyperactivity disorder	score assessed by Swanson, Nolan and Pelham questionnaire	score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes of sensory integration	score assessed by Sensory Profile	score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of visual motor integration	score assessed by Beery-Buktenica Visual Motor Integration Test	score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of intelligence	score assessed by Wechsler Intelligence Scale for Children	score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of functional performance	score assessed by Pediatric Outcome Data Collection Instrument	score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of health-related quality of life	score assessed by Pediatric Quality of Life Inventory	score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of family impact	Child Health Questionnaire, parent form 28	score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of walking speed	walking speed	time change from baseline to 3 months of treatment, and 3 months after treatment
changes of chair climbing speed	stairs climbing speed	time change from baseline to 3 months of treatment, and 3 months after treatment
changes of balance	one leg standing time	time change from baseline to 3 months of treatment, and 3 months after treatment
changes of coordination	Berg Balance Scale	score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of balance and coordination	timed up and go test	time change from baseline to 3 months of treatment, and 3 months after treatment
changes of physical performance	5 time sit to stand test	time change from baseline to 3 months of treatment, and 3 months after treatment

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Ru-Lan Ru-Lan, MD, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: children; developmental delay; therapeutic effects; attention training
• 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: 2019SKHADR038

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