The Effect of Physical Effort in the Decision Making Proc... | NCT01978769

Studies
The Effect of Physical Effort in the Decision Making Process of Preadolescents With ADHD

NCT01978769

Sponsor

Shaare Zedek Medical Center

Status

Completed

Last Update Posted

Sep 9, 2015Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

ADHD

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Jul 11, 2013

First Submission Date that Met QC Criteria

Oct 31, 2013

First Posted Date

Nov 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2015

Last Update Posted Date

Sep 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In the current study we will examine a specific aspect of these processes that has yet to be studied. We will test the effect that a physically effortful assignment has on the choices that a preadolescent makes using a forced choice paradigm in which the participant will be asked to choose between and carry out either a high cost-high reward option (HR) or a low cost-low reward (LR) option. The HR option will demand a significant amount of physical effort and will be paired up with a large reward as opposed to the LR option which will be less demanding physically and paired up with a small reward. The assignment will be carried out using a hand held dynamometer which measures the power produced by the participants' upper extremity.

We propose that a child with attention deficit hyperactivity disorder (ADHD) will choose a task that involves less effort despite the small reward tied to it compared to a control child who will choose the more demanding task and the larger reward.

Detailed Description

We propose that a child with ADHD will choose a task that involves less effort despite the small reward tied to it compared to a control child who will choose the more demanding task and the larger reward.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preadolescents with ADHD		preadolescents with prior diagnosis of ADHD and without any other psychiatric or neurological diagnosis.
Preadolescents with out any diagnosis		Preadolescents with out any diagnosis

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of "low effort" choices of the ADHD participants compared to the number of "low effort" choices of the control participants		immediately after testing

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of ADHD

Exclusion Criteria:

any other neurological or psychiatric diagnosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

residents of jerusalem

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
yehuda polak, Dr.	Hebrew University of Jerusalem	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaarei Zedek Medical Center		Jerusalem	Israel		Israel

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided