Clinical trial NCT04375059: Effects of Attention Training on Children
Official title: Therapeutic Effects of Interactive Attention Training on Children With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: attention training
children
therapeutic effects
developmental delay
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes of symptoms of attention deficit hyperactivity disorder
timeFrame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
Secondary outcomes:
measure: changes of sensory integration
timeFrame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of visual motor integration
timeFrame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of intelligence
timeFrame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of functional performance
timeFrame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of health-related quality of life
timeFrame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of family impact
timeFrame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of walking speed
timeFrame: time change from baseline to 3 months of treatment, and 3 months after treatment
measure: changes of chair climbing speed
timeFrame: time change from baseline to 3 months of treatment, and 3 months after treatment
measure: changes of balance
timeFrame: time change from baseline to 3 months of treatment, and 3 months after treatment
measure: changes of coordination
timeFrame: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
measure: changes of balance and coordination
timeFrame: time change from baseline to 3 months of treatment, and 3 months after treatment
measure: changes of physical performance
timeFrame: time change from baseline to 3 months of treatment, and 3 months after treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Ru-Lan Ru-Lan, MD
role: PRINCIPAL_INVESTIGATOR
References: