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

Phase 3

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Other: Computerized cognitive rehabilitation; Other: Placebo CACR [PCACR]; Drug: Ritalin

• Registration Number: NCT01675804
• Lead Sponsor: Allameh Tabatabai University

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.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Study First Submitted: 2012-07-29
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-30
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-03
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computerized cognitive rehabilitation	Computerized cognitive rehabilitation	-Computer-assisted cognitive rehabilitation (CACR): 20 Ninety-minute sessions of CACR.
Placebo CACR [PCACR]	Placebo CACR [PCACR]	-PCACR group simultaneously received 20 Ninety-minute sessions of Placebo CACR.
Ritalin	Ritalin	-2 to 3 doses of 10 mg Ritalin tablets per day during two months.

Primary Outcome Measures

Name	Time	Method
Forward/Reversed digit span tasks from the WISC-R testing battery.	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.
Raven's colored progressive matrices.	5 months	Raven's colored progressive matrices (Raven, 1995) was used to measure complex non-verbal reasoning.
Persian software for the continuous performance test [CPT]	5 months	The Persian software of CPT is a visual CPT test.
Persian software for the Tower of London Test [TOL]	5 months	Persian TOL is a software version of tower of London test (TOL) which was developed in Iran.
Span board task from the Lumosity.com online software (Lumosity.com, 2012)	5 months
SNAP-IV scales	5 months

Trial Locations

Locations (1)

Counseling and guidence Center of the Department of education of region 9 of Tehran; 🇮🇷 Tehran, Iran, Islamic Republic of