Clinical trial NCT03632629: Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder
Official title: Treatment Effects of Cognitive Training on Children With Attention Deficit Hyperactivity Disorder and Developmental Delay
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: cognitive training
developmental delay
children
therapeutic effect
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2018-08-15
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: change of attention
timeFrame: scores change from baseline to 3 months of treatment, and 3 months after treatment
Secondary outcomes:
measure: change of visual motor integration
timeFrame: scores change from baseline to 3 months of treatment, and 3 months after treatment
measure: change of sensory integration
timeFrame: scores change from baseline to 3 months of treatment, and 3 months after treatment
measure: change of intelligence
timeFrame: scores change from baseline to 3 months of treatment, and 3 months after treatment
measure: change of functional performance
timeFrame: changes from baseline to 3 months of treatment, and 3 months after treatment
measure: change of health-related quality of life
timeFrame: changes 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 Hsieh
role: PRINCIPAL_INVESTIGATOR
References: