Clinical trial NCT05502536: Effects of Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder
Official title: Effects of Individualized Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder With Developmental Delay
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Delay
Preschool Children
Attention Deficit Hyperactivity Disorder
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes of hyperactivity
timeFrame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
measure: changes of attention
timeFrame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
Secondary outcomes:
measure: change of vocabulary
timeFrame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
measure: change of sensory integration
timeFrame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
measure: change of intelligence
timeFrame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
measure: change of physical functional performance
timeFrame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
measure: change of quality of life
timeFrame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
measure: change of family impact
timeFrame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
measure: change of walking time
timeFrame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
measure: change of stairs climbing time
timeFrame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
measure: change of balance
timeFrame: score change from baseline to 12 weeks of treatment, and 12 weeks after treatment
measure: change of physical function
timeFrame: score change from baseline to 12 weeks of treatment, and 12 weeks 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, MD
role: PRINCIPAL_INVESTIGATOR
References: