Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control in the Treatment of ADHD

Study Overview
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Brief Summary
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The investigators administered a randomized controlled trial (RCT) through random assignment of children with ADHD into three different groups to compare the effects of cognitive-motor rehabilitation, immediate release methylphenidate, and an active control on the executive functioning, learning, and behavioral symptoms of children with ADHD.

Official Title
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Comparison of the Effects of Cognitive-Motor Rehabilitation, Stimulant Drugs, and Active Control on Executive Functions and Clinical Symptoms of Attention Deficit/ Hyperactivity Disorder

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Other: Cognitive-Motor Rehabilitation
* Drug: Ritalin
* Other: Active Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving ADHD diagnosis aged between 9 and 12 years Intelligence Quotient (IQ)>90 Exclusion Criteria: Severe co-morbid disorders, such as depression, op-positional defiant disorder and conduct disorder A history of seizures during past 2 years Disability or handicap preventing the child from participating cognitive-motor exercises Sever medical conditions requiring immediate medical treatment

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-Motor Rehabilitation<br>Cognitive-Motor Rehabilitation (CMR): 20 sixty-minute sessions of cognitive-motor rehabilitation | Other: Cognitive-Motor Rehabilitation<br>* Cognitive-Motor Rehabilitation (CMR) group received 20 sixty-minute sessions of cognitive-motor exercises<br>|
| Experimental: Ritalin<br>2 to 3 doses of 10 mg Ritalin tablets per day during 8 week. | Drug: Ritalin<br>* 2 or 3 doses of 10 mg tablets of immediate-release Methylphenidate (Ritalin) per day for 8 week.<br>* Other names: drug therapy;|
| Active Comparator: Active Control<br>Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises | Other: Active Control<br>* Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV) |  | 12 months | 
| Span board task from the Lumosity.com online brain training software |  | 12 months | 
| Listening span task (L.SPAN) |  | 12 months | 
| Stroop color-word test |  | 12 months | 
| Tower of London test (TOL) |  | 12 months | 
| Restricted academic situation scale (RASS) |  | 12 months | 
| Arithmetic task from WISC-IV testing battery |  | 12 months | 
| Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV) |  | 12 months | 
| Dictation and Spelling examination |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Cognitive-motor rehabilitation, Active Control Group, Stimulant Medication