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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Computerized cognitive rehabilitation
Ritalin
Placebo CACR [PCACR]
Sponsored by
Allameh Tabatabai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD

Eligibility Criteria

7 Years - 12 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Computerized cognitive rehabilitation

Placebo CACR [PCACR]

Ritalin

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Persian software for the continuous performance test [CPT]
The Persian software of CPT is a visual CPT test.
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.
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.
Raven's colored progressive matrices.
Raven's colored progressive matrices (Raven, 1995) was used to measure complex non-verbal reasoning.
Span board task from the Lumosity.com online software (Lumosity.com, 2012)
SNAP-IV scales

Secondary Outcome Measures

Full Information

First Posted
July 29, 2012
Last Updated
April 3, 2015
Sponsor
Allameh Tabatabai University
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1. Study Identification

Unique Protocol Identification Number
NCT01675804
Brief Title
Computer-assisted Cognitive Rehabilitation (CACR), Placebo CACR and Psycho-stimulants in the Treatment of ADHD
Official Title
A Randomized Clinical Trial Comparing Computer-assisted Cognitive Rehabilitation (CACR), Psycho-stimulants, and Placebo CACR in the Treatment of Attention Deficit/ Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allameh Tabatabai University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerized cognitive rehabilitation
Arm Type
Experimental
Arm Description
-Computer-assisted cognitive rehabilitation (CACR): 20 Ninety-minute sessions of CACR.
Arm Title
Placebo CACR [PCACR]
Arm Type
Placebo Comparator
Arm Description
-PCACR group simultaneously received 20 Ninety-minute sessions of Placebo CACR.
Arm Title
Ritalin
Arm Type
Experimental
Arm Description
-2 to 3 doses of 10 mg Ritalin tablets per day during two months.
Intervention Type
Other
Intervention Name(s)
Computerized cognitive rehabilitation
Intervention Description
- Computerized cognitive rehabilitation: 20 ninety-minute sessions of computerized cognitive rehabilitation.
Intervention Type
Drug
Intervention Name(s)
Ritalin
Other Intervention Name(s)
Immediate release methylphenidate
Intervention Description
-drug therapy: 2 or 3 doses of 10 mg tablets of Immediate-release Methylphenidate (Ritalin) per day for 2 months.
Intervention Type
Other
Intervention Name(s)
Placebo CACR [PCACR]
Intervention Description
PCACR: 20 ninety-minute sessions of Placebo computerized cognitive training.
Primary Outcome Measure Information:
Title
Persian software for the continuous performance test [CPT]
Description
The Persian software of CPT is a visual CPT test.
Time Frame
5 months
Title
Persian software for the Tower of London Test [TOL]
Description
Persian TOL is a software version of tower of London test (TOL) which was developed in Iran.
Time Frame
5 months
Title
Forward/Reversed digit span tasks from the WISC-R testing battery.
Description
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.
Time Frame
5 months
Title
Raven's colored progressive matrices.
Description
Raven's colored progressive matrices (Raven, 1995) was used to measure complex non-verbal reasoning.
Time Frame
5 months
Title
Span board task from the Lumosity.com online software (Lumosity.com, 2012)
Time Frame
5 months
Title
SNAP-IV scales
Time Frame
5 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ADHD diagnosis age between 7 and 12 IQ > 85 Exclusion Criteria: sever co-morbid disorder seizure IQ < 85 disability sever medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saeed Azami, MSc
Organizational Affiliation
Candidate for PhD in Psychology, Department of Psychology, Semnan University, Semnan, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alireza Moghadas, PhD
Organizational Affiliation
Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Faramarz Sohrabi, PhD
Organizational Affiliation
Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Morteza Nazifi, PhD
Organizational Affiliation
Department of psychology, University of Bojnord, Bojnord, Iran.
Official's Role
Study Director
Facility Information:
Facility Name
Counseling and guidence Center of the Department of education of region 9 of Tehran
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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