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

April 3, 2015 updated by: Allameh Tabatabai University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Counseling and guidence Center of the Department of education of region 9 of Tehran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computerized cognitive rehabilitation
-Computer-assisted cognitive rehabilitation (CACR): 20 Ninety-minute sessions of CACR.
Other: Computerized cognitive rehabilitation
- Computerized cognitive rehabilitation: 20 ninety-minute sessions of computerized cognitive rehabilitation.
Placebo Comparator: Placebo CACR [PCACR]
-PCACR group simultaneously received 20 Ninety-minute sessions of Placebo CACR.
Other: Placebo CACR [PCACR]
PCACR: 20 ninety-minute sessions of Placebo computerized cognitive training.
Experimental: Ritalin
-2 to 3 doses of 10 mg Ritalin tablets per day during two months.
Drug: Ritalin
-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persian software for the continuous performance test [CPT]
Time Frame: 5 months
The Persian software of CPT is a visual CPT test.
5 months
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.
5 months
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.
5 months
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 months
Span board task from the Lumosity.com online software (Lumosity.com, 2012)
Time Frame: 5 months
5 months
SNAP-IV scales
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allameh Tabatabai University

Investigators

  • Principal Investigator: Saeed Azami, MSc, Candidate for PhD in Psychology, Department of Psychology, Semnan University, Semnan, Iran
  • Study Director: Alireza Moghadas, PhD, Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.
  • Study Director: Faramarz Sohrabi, PhD, Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.
  • Study Director: Morteza Nazifi, PhD, Department of psychology, University of Bojnord, Bojnord, Iran.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

July 29, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimate)

August 30, 2012

Study Record Updates

Last Update Posted (Estimate)

April 6, 2015

Last Update Submitted That Met QC Criteria

April 3, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83-6516

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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