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Clinical Trials/NCT01675804
NCT01675804
Completed
Phase 3

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

Allameh Tabatabai University1 site in 1 country34 target enrollmentNovember 2011

Overview

Phase
Phase 3
Intervention
Computerized cognitive rehabilitation
Conditions
Attention Deficit Disorder With Hyperactivity
Sponsor
Allameh Tabatabai University
Enrollment
34
Locations
1
Primary Endpoint
Forward/Reversed digit span tasks from the WISC-R testing battery.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
May 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Allameh Tabatabai University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ADHD diagnosis
  • age between 7 and 12

Exclusion Criteria

  • sever co-morbid disorder
  • disability
  • sever medical condition

Arms & Interventions

Computerized cognitive rehabilitation

-Computer-assisted cognitive rehabilitation (CACR): 20 Ninety-minute sessions of CACR.

Intervention: Computerized cognitive rehabilitation

Placebo CACR [PCACR]

-PCACR group simultaneously received 20 Ninety-minute sessions of Placebo CACR.

Intervention: Placebo CACR [PCACR]

Ritalin

-2 to 3 doses of 10 mg Ritalin tablets per day during two months.

Intervention: Ritalin

Outcomes

Primary Outcomes

Forward/Reversed digit span tasks from the WISC-R testing battery.

Time Frame: 5 months

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.

Raven's colored progressive matrices.

Time Frame: 5 months

Raven's colored progressive matrices (Raven, 1995) was used to measure complex non-verbal reasoning.

Persian software for the continuous performance test [CPT]

Time Frame: 5 months

The Persian software of CPT is a visual CPT test.

Persian software for the Tower of London Test [TOL]

Time Frame: 5 months

Persian TOL is a software version of tower of London test (TOL) which was developed in Iran.

Span board task from the Lumosity.com online software (Lumosity.com, 2012)

Time Frame: 5 months

SNAP-IV scales

Time Frame: 5 months

Study Sites (1)

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