ADHDNCT01978769
The Effect of Physical Effort in the Decision Making Process of Preadolescents With ADHD
An observational study of ADHD, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 13 years
- Conditions the study is for
- ADHD
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: residents of jerusalem
Who may be able to join
- clinical diagnosis of ADHD
Who cannot join
- any other neurological or psychiatric diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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 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.
- Conditions
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of "low effort" choices of the ADHD participants compared to the number of "low effort" choices of the control participants
Measured: immediately after testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yehuda polak, Dr., Principal investigator, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978769
- Sponsor's protocol ID
- effortdiscounting.ctil
- Status last verified
- Jul 2013
- First submitted
- 11 Jul 2013
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Effort in the Decision Making Process of Preadolescents With ADHD
- ClinicalTrials.gov ID
- NCT01978769
- Acronym / sponsor ID
- effortdiscounting.ctil
- Conditions
- ADHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- residents of jerusalem
Key inclusion criteria (1 listed)
- clinical diagnosis of ADHD
Key exclusion criteria (1 listed)
- any other neurological or psychiatric diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of "low effort" choices of the ADHD participants compared to the number of "low effort" choices of the control participants
Time frame: immediately after testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
Related trials for ADHD
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yehuda polak, Dr. principal investigator
Hebrew University of Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of "low effort" choices of the ADHD participants compared to the number of "low effort" choices of the control participants (time frame: immediately after testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.