Effects of Attention Training on Children

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04375059
• Other study ID #: 2019SKHADR038
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• using interactive attention training system
using the interactive attention training system to children with Attention Deficit Hyperactivity Disorder

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	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	changes of walking speed	walking speed	time change from baseline to 3 months of treatment, and 3 months after treatment
Secondary	changes of chair climbing speed	stairs climbing speed	time change from baseline to 3 months of treatment, and 3 months after treatment
Secondary	changes of balance	one leg standing time	time change from baseline to 3 months of treatment, and 3 months after treatment
Secondary	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
Secondary	changes of balance and coordination	timed up and go test	time change from baseline to 3 months of treatment, and 3 months after treatment
Secondary	changes of physical performance	5 time sit to stand test	time change from baseline to 3 months of treatment, and 3 months after treatment