Attention Deficit Hyperactivity Disorder, Developmental Delay, Preschool Children
Conditions
Brief summary
Under traditional rehabilitation programs, investigate the additional effects of individualized fairytales on preschool children with Attention Deficit Hyperactivity Disorder with developmental delays.
Detailed description
Thirty preschool children with Attention Deficit Hyperactivity Disorder and developmental delays will be enrolled in regular traditional rehabilitation programs. They will be randomized to the intervention group and control group. The participants in the intervention group will receive an additional 30 minutes per week for 12 sessions of individualized fairytales classes by a child and educational teacher for three months. The participants of both groups will continue to receive the traditional rehabilitation programs. Therapeutic effects, including attention, cognitive function, vocabulary function, physical functional performance, and quality of life at baseline, will be evaluated after 12 weeks of treatment and three months after the treatment. The evaluator will be blinded to the group's allocation during the whole course of the intervention.
Interventions
OTHERTraditional rehabilitation programs with Individualized fairytales class
In addition to traditional rehabilitation programs, 30 minutes per week for 12 sessions of individualized fairytales classes by a child and educational teacher for three months, to preschool children with Attention Deficit Hyperactivity Disorder and developmental delays in regular traditional rehabilitation programs
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participants and outcome assessor will be blinded to the groups' allocation.
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* preschool children with a diagnosis of Attention Deficit Hyperactivity Disorder and developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater
Exclusion criteria
* age less than 3 or greater than 6 of children diagnosed with Attention Deficit Hyperactivity Disorder and developmental delay, under regular traditional rehabilitation programs, intelligence quotient below 70
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes of hyperactivity | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | score assessed by Swanson, Nolan and Pelham questionnaire, higher score indicating greater hyperactivity |
| changes of attention | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | score change by Conners Kiddie Continuous Performance Test, greater score indicating lower attention span |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of intelligence | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | score change by Wechsler Intelligence Scale for Children, the average score is 100, with a higher score indicating higher intelligence and a lower score indicating a lower level of intelligence |
| change of physical functional performance | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | score assessed by Pediatric Outcome Data Collection Instrument, 0-100, a higher score indicating greater performance |
| change of quality of life | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | score assessed by the Pediatric Quality of Life Inventory, 0-100, a higher score indicating a greater quality of life |
| change of family impact | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | score assessed by Child Health Questionnaire, parent form 28, 0-100, a higher score indicating better performance |
| change of vocabulary | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | score change by Receptive and Expressive Vocabulary Test, higher score indicating greater performance |
| change of stairs climbing time | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | climbing time |
| change of balance | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | one leg standing time |
| change of physical function | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | 5 times sit to stand up |
| change of walking time | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | walking time |
| change of sensory integration | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment | score change by Sensory Profile, 0-100, higher score indicating better sensory profile |
Countries
Taiwan
Contacts
Primary ContactRu-Lan Hsieh, MD
Outcome results
None listed