Computer-assisted Cognitive Rehabilitation (CACR), Placebo CACR and Psycho-stimulants in the Treatment of ADHD

Study Overview
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Brief Summary
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Current research aimed to compare the efficacy of computer-assisted cognitive rehabilitation (CACR), stimulant drugs and Placebo CACR on executive functions and clinical symptoms of children with attention deficit/hyperactivity disorder (ADHD).

Detailed Description
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The investigators administered a randomized controlled trial (RCT) through random assignment of ADHD subjects in to three different groups to compare the effects of CACR, immediate-release methylphenidate, and a Placebo CACR (i.e. some computerized tasks assumed not having any therapeutic effects) on the functioning of children with ADHD.

Official Title
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A Randomized Clinical Trial Comparing Computer-assisted Cognitive Rehabilitation (CACR), Psycho-stimulants, and Placebo CACR in the Treatment of Attention Deficit/ Hyperactivity Disorder

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Other: Computerized cognitive rehabilitation
* Drug: Ritalin
* Other: Placebo CACR [PCACR]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ADHD diagnosis age between 7 and 12 IQ > 85 Exclusion Criteria: sever co-morbid disorder seizure IQ < 85 disability sever medical condition

Ages Eligible for Study
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Minimum Age: 7 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized cognitive rehabilitation<br>-Computer-assisted cognitive rehabilitation (CACR): 20 Ninety-minute sessions of CACR. | Other: Computerized cognitive rehabilitation<br>* - Computerized cognitive rehabilitation: 20 ninety-minute sessions of computerized cognitive rehabilitation.<br>|
| Placebo Comparator: Placebo CACR [PCACR]<br>-PCACR group simultaneously received 20 Ninety-minute sessions of Placebo CACR. | Other: Placebo CACR [PCACR]<br>* PCACR: 20 ninety-minute sessions of Placebo computerized cognitive training.<br>|
| Experimental: Ritalin<br>-2 to 3 doses of 10 mg Ritalin tablets per day during two months. | Drug: Ritalin<br>* -drug therapy: 2 or 3 doses of 10 mg tablets of Immediate-release Methylphenidate (Ritalin) per day for 2 months.<br>* Other names: Immediate release methylphenidate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persian software for the continuous performance test [CPT] | The Persian software of CPT is a visual CPT test. | 5 months | 
| Persian software for the Tower of London Test [TOL] | Persian TOL is a software version of tower of London test (TOL) which was developed in Iran. | 5 months | 
| Forward/Reversed digit span tasks from the WISC-R testing battery. | Reversed digit span from the WISC-R (Wechsler, 1974) was used to measure executive verbal WM and the forward digit span was used to measure short-term memory. | 5 months | 
| Raven's colored progressive matrices. | Raven's colored progressive matrices (Raven, 1995) was used to measure complex non-verbal reasoning. | 5 months | 
| Span board task from the Lumosity.com online software (Lumosity.com, 2012) |  | 5 months | 
| SNAP-IV scales |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD