NCT01531127

Brief Summary

The purpose of this study is to determine whether there is a difference in executive function in learning in children with ADHD receiving medical treatment alone to the executive function in children receiving, in addition to medical treatment in learning strategies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

February 10, 2012

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

February 8, 2012

Last Update Submit

February 9, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Level of Executive Functioning

    Brief Behavior Rating Inventory of Executive Function will be administered

    One year

Study Arms (2)

Combined Therapy

ADHD Medication and Learning Strategies Treatment

ADHD Medication Treatment

Control group

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with ADHD treated in the Institute for Child Development at Hillel Yaffe Medical Center

You may qualify if:

  • Normal development for age
  • ADHD

You may not qualify if:

  • Low compliance
  • Developmental delay
  • Chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Muhammad Mahajnah, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 10, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

February 10, 2012

Record last verified: 2012-02

Locations