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Under traditional rehabilitation programs, investigate the additional effects of individualized fairytales on preschool children with Attention Deficit Hyperactivity Disorder with developmental delays.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | traditional rehabilitation programs with additional individualized fairytales class |
|
| Control group | No Intervention | traditional rehabilitation programs without additional individualized fairytales class |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional rehabilitation programs with Individualized fairytales class | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| changes of hyperactivity | score assessed by Swanson, Nolan and Pelham questionnaire, higher score indicating greater hyperactivity | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |
| changes of attention | score change by Conners Kiddie Continuous Performance Test, greater score indicating lower attention span | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| change of vocabulary | score change by Receptive and Expressive Vocabulary Test, higher score indicating greater performance | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |
| change of sensory integration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ru-Lan Hsieh, MD | Contact | 886-2-28332211 | 2531 | M001052@ms.skh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ru-Lan Hsieh, MD | Shin Kong Wu Ho-Su Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | Taipei | 111-01 | Taiwan |
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The participants and outcome assessor will be blinded to the groups' allocation.
|
score change by Sensory Profile, 0-100, higher score indicating better sensory profile
| score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |
| change of intelligence | 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 | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |
| change of physical functional performance | score assessed by Pediatric Outcome Data Collection Instrument, 0-100, a higher score indicating greater performance | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |
| change of quality of life | score assessed by the Pediatric Quality of Life Inventory, 0-100, a higher score indicating a greater quality of life | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |
| change of family impact | score assessed by Child Health Questionnaire, parent form 28, 0-100, a higher score indicating better performance | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |
| change of walking time | walking time | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |
| change of stairs climbing time | climbing time | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |
| change of balance | one leg standing time | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |
| change of physical function | 5 times sit to stand up | score change from baseline to 12 weeks of treatment, and 12 weeks after treatment |
| ID | Term |
|---|---|
| D007859 | Learning Disabilities |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
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