ADHDNCT01574976
Effect of Feedback and Practice on Probabilistic Decision Making in Attention Deficit and Hyperactivity Disorder
A study testing probabilistic choice in people with ADHD, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine how feedback and practice affect decision making in adolescents with attention deficit and hyperactivity disorder. Participants will have to choose between low and certain outcome and a higher but uncertain outcome, with or without serial feedback after each trial. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- probabilistic choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- May 2015to Nov 2015
- Phase
- Interventional
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ADHD
Who cannot join
- Current major depression,
- Psychosis,
- Autism,
- Tourette syndrome
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine how feedback and practice affect decision making in adolescents with attention deficit and hyperactivity disorder.
Participants will have to choose between low and certain outcome and a higher but uncertain outcome, with or without serial feedback after each trial. Participants will perform the task twice to examine practice effects.
- Conditions
- ADHD
- Being tested
- probabilistic choice
- Keywords
- ADHD, probabilistic, choice, feedback, practice
- 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.
probabilistic choiceBehavioural
subjects should choose between low-certain outcome and high-uncertain outcome
| Study group | Role | What they receive |
|---|---|---|
| control, no feeback | Active comparator | subjects without ADHD, probabilistic choices without feedback Receives: Behavioral: probabilistic choice |
| control, feedback | Active comparator | subjects without ADHD, probabilistic choices with feedback Receives: Behavioral: probabilistic choice |
| ADHD, no feedback | Experimental | subjects with ADHD, probabilistic choices without feedback Receives: Behavioral: probabilistic choice |
| adhd, feedback | Experimental | subjects with ADHD, probabilistic choices with feedback Receives: Behavioral: probabilistic choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
probabilistic choice
The number of risky outcomes a subject chose on a probabilistic choice paradigm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionNov 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yehuda Pollak, Shaare Zedek Medical Center
- Investigators
- Yehuda Pollak, PhD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574976
- Sponsor's protocol ID
- 37/12
- Status last verified
- Nov 2015
- First submitted
- 1 Apr 2012
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Feedback and Practice on Probabilistic Decision Making in Attention Deficit and Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01574976
- Acronym / sponsor ID
- 37/12
- Conditions
- ADHD
- Keywords
- ADHD, probabilistic, choice, feedback, practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Apr 2012 (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.
The purpose of this study is to determine how feedback and practice affect decision making in adolescents with attention deficit and hyperactivity disorder.
Participants will have to choose between low and certain outcome and a higher but uncertain outcome, with or without serial feedback after each trial. Participants will perform the task twice to examine practice effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control, no feeback | Active comparator | Behavioral: probabilistic choicesubjects without ADHD, probabilistic choices without feedback |
| control, feedback | Active comparator | Behavioral: probabilistic choicesubjects without ADHD, probabilistic choices with feedback |
| ADHD, no feedback | Experimental | Behavioral: probabilistic choicesubjects with ADHD, probabilistic choices without feedback |
| adhd, feedback | Experimental | Behavioral: probabilistic choicesubjects with ADHD, probabilistic choices with feedback |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- ADHD
Key exclusion criteria (4 listed)
- Current major depression,
- Psychosis,
- Autism,
- Tourette syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probabilistic choicesubjects should choose between low-certain outcome and high-uncertain outcome | Behavioural | ADHD, no feedback, adhd, feedback, control, feedback, control, no feeback |
Primary outcome
probabilistic choice
Time frame: 1 year
The number of risky outcomes a subject chose on a probabilistic choice paradigm
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 17 Nov 2015.
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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 Pollak, PhD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probabilistic choice in people with 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 4 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 17 Nov 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?
probabilistic choice (time frame: 1 year). 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 17 Nov 2015.