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Completed

NCT Number: NCT01675804

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

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).

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Counseling and guidence Center of the Department of education of region 9 of Tehran

Tehran, Tehran Province, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ADHD diagnosis
  • age between 7 and 12
  • IQ > 85

Exclusion criteria

  • sever co-morbid disorder
  • seizure
  • IQ < 85
  • disability
  • sever medical condition

Treatment and study plan

Computerized cognitive rehabilitation

Other
  • Computerized cognitive rehabilitation: 20 ninety-minute sessions of computerized cognitive rehabilitation.

Ritalin

Drug

-drug therapy: 2 or 3 doses of 10 mg tablets of Immediate-release Methylphenidate (Ritalin) per day for 2 months.

Other names: Immediate release methylphenidate

Placebo CACR [PCACR]

Other

PCACR: 20 ninety-minute sessions of Placebo computerized cognitive training.

Primary outcomes

  1. Persian software for the continuous performance test [CPT]

    Time frame: 5 months

    The Persian software of CPT is a visual CPT test.

  2. 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.

  3. 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.

  4. Raven's colored progressive matrices.

    Time frame: 5 months

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

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

    Time frame: 5 months

  6. SNAP-IV scales

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Allameh Tabatabai University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 30, 2012
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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