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

NCT ID: NCT01675804

Last Updated: 2015-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-05-31

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.

Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Computerized cognitive rehabilitation

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

Group Type EXPERIMENTAL

Computerized cognitive rehabilitation

Intervention Type OTHER

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

Placebo CACR [PCACR]

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

Group Type PLACEBO_COMPARATOR

Placebo CACR [PCACR]

Intervention Type OTHER

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

Ritalin

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

Group Type EXPERIMENTAL

Ritalin

Intervention Type DRUG

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

Interventions

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Computerized cognitive rehabilitation

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

Intervention Type OTHER

Ritalin

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

Intervention Type DRUG

Placebo CACR [PCACR]

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

Intervention Type OTHER

Other Intervention Names

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Immediate release methylphenidate

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Allameh Tabatabai University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saeed Azami, MSc

Role: PRINCIPAL_INVESTIGATOR

Candidate for PhD in Psychology, Department of Psychology, Semnan University, Semnan, Iran

Alireza Moghadas, PhD

Role: STUDY_DIRECTOR

Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.

Faramarz Sohrabi, PhD

Role: STUDY_DIRECTOR

Department of Clinical Psychology, Allameh Tabatabaei University, Tehran, Iran.

Morteza Nazifi, PhD

Role: STUDY_DIRECTOR

Department of psychology, University of Bojnord, Bojnord, Iran.

Locations

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

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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83-6516

Identifier Type: -

Identifier Source: org_study_id

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