Clinical trial NCT06277440: Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays
Official title: Cognitive Training Effects for Preschool Children With Attention Deficit Hyperactivity Disorder and Developmental Delays
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorders
Developmental Delays
Keywords: preschool children
developmental delay
cognitive training
attention deficit hyperactivity disorder
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twenty preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated by an investigator blinded to the group's allocation before and after 12 weeks of treatment.
Primary purpose: TREATMENT

Brief summary: To explore whether children with Attention Deficit Hyperactivity Disorder and developmental delays who receive cognitive training and conventional rehabilitation can improve executive function more than traditional rehabilitation alone. A magnetoencephalographic examination will be arranged to explore how brain network activation works.

Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated.

Detailed description: Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated, including Sensory Profile, Swanson, Nolan and Pelham version IV, Conners Kiddie Continuous Performance test, Chinese Childhood Executive Functioning Inventory, and Chinese version of Wechsler Intelligence Scale for Children-IV; and physical health conditions, including Pediatric Daily Occupation Scale, Pediatric Outcome Data Collection Instrument (PODCI), Child Health Questionnaire- Parent Form, Pediatric Quality of Life Inventory (PedsQL)will be evaluated by an investigator who is blinded to the group's allocation at before treatment and after 12 weeks of treatment. All participants will be investigated by magnetoencephalography (MEG) to identify the brain network connectivity while performing different tasks before and after 12 weeks of treatment. Brain Magnetic Resonance Imaging will be performed for brain mapping.

Possible results: The study will shed light on therapeutic effects and brain network connectivity by cognitive training for preschool children with Attention Deficit Hyperactivity Disorder and developmental delays.

Eligibility criteria: Inclusion Criteria:

* preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under regular rehabilitation programs intelligence quotient 70 or greater

Exclusion Criteria:

* age less than 4 or greater than 6 metal in teeth intelligence quotient less than 70

Primary outcomes:
measure: Changes of executive function
timeFrame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Secondary outcomes:
measure: changes of symptoms of attention deficit hyperactivity disorder
timeFrame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
measure: changes of attention
timeFrame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
measure: Changes of sensory integration
timeFrame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
measure: changes of intelligence
timeFrame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
measure: changes of functional performance
timeFrame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
measure: Changes of family impact
timeFrame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
measure: Changes of quality of life
timeFrame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
measure: Changes in performance activity in kindergarten
timeFrame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
Other outcomes:
measure: changes of brain network connectivity
timeFrame: connectivity change from baseline to 12 weeks of treatment, higher score, the better outcome
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, MD
role: PRINCIPAL_INVESTIGATOR
References: