NCT02780102

Brief Summary

The investigators administered a randomized controlled trial (RCT) through random assignment of children with ADHD into three different groups to compare the effects of cognitive-motor rehabilitation, immediate release methylphenidate, and an active control on the executive functioning, learning, and behavioral symptoms of children with ADHD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

May 19, 2016

Last Update Submit

February 2, 2021

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDCognitive-motor rehabilitationActive Control GroupStimulant Medication

Outcome Measures

Primary Outcomes (9)

  • Forward/backward digit span tasks from the Wechsler intelligence scale for children 4th edition (WISC-IV)

    12 months

  • Span board task from the Lumosity.com online brain training software

    12 months

  • Listening span task (L.SPAN)

    12 months

  • Stroop color-word test

    12 months

  • Tower of London test (TOL)

    12 months

  • Restricted academic situation scale (RASS)

    12 months

  • Arithmetic task from WISC-IV testing battery

    12 months

  • Swanson, Nolan, and Pelham's parent rating scale (SNAP-IV)

    12 months

  • Dictation and Spelling examination

    12 months

Study Arms (3)

Cognitive-Motor Rehabilitation

EXPERIMENTAL

Cognitive-Motor Rehabilitation (CMR): 20 sixty-minute sessions of cognitive-motor rehabilitation

Other: Cognitive-Motor Rehabilitation

Ritalin

EXPERIMENTAL

2 to 3 doses of 10 mg Ritalin tablets per day during 8 week.

Drug: Ritalin

Active Control

ACTIVE COMPARATOR

Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises

Other: Active Control

Interventions

Cognitive-Motor RehabilitationOTHER

Cognitive-Motor Rehabilitation (CMR) group received 20 sixty-minute sessions of cognitive-motor exercises

Cognitive-Motor Rehabilitation
RitalinDRUG

2 or 3 doses of 10 mg tablets of immediate-release Methylphenidate (Ritalin) per day for 8 week.

Also known as: drug therapy
Ritalin
Active ControlOTHER

Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises

Active Control

Eligibility Criteria

Age9 Years - 12 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Receiving ADHD diagnosis
  • aged between 9 and 12 years
  • Intelligence Quotient (IQ)\>90

You may not qualify if:

  • Severe co-morbid disorders, such as depression, op-positional defiant disorder and conduct disorder
  • A history of seizures during past 2 years
  • Disability or handicap preventing the child from participating cognitive-motor exercises
  • Sever medical conditions requiring immediate medical treatment

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, Iran

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

MethylphenidateDrug Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Saeed Azami, PhD

    Semnan University

    STUDY DIRECTOR

  • Zeynab AliMadadi, MD

    Tehran University of medical Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 23, 2016

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

August 1, 2017

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)