NCT01675804

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

July 29, 2012

Last Update Submit

April 3, 2015

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD

Outcome Measures

Primary Outcomes (6)

  • Persian software for the continuous performance test [CPT]

    The Persian software of CPT is a visual CPT test.

    5 months

  • 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.

    5 months

  • 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.

    5 months

  • Raven's colored progressive matrices.

    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)

    5 months

  • SNAP-IV scales

    5 months

Study Arms (3)

Computerized cognitive rehabilitation

EXPERIMENTAL

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

Other: Computerized cognitive rehabilitation

Placebo CACR [PCACR]

PLACEBO COMPARATOR

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

Other: Placebo CACR [PCACR]

Ritalin

EXPERIMENTAL

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

Drug: Ritalin

Interventions

Computerized cognitive rehabilitationOTHER

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

Computerized cognitive rehabilitation
RitalinDRUG

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

Also known as: Immediate release methylphenidate
Ritalin
Placebo CACR [PCACR]OTHER

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

Placebo CACR [PCACR]

Eligibility Criteria

Age7 Years - 12 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Saeed Azami, MSc

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

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2012

First Posted

August 30, 2012

Study Start

November 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

IR(1)