ADHDNCT01994694
Risk Perception in Adults With Attention Deficit and Hyperactivity Disorder (ADHD)
An observational study of ADHD, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
People with ADHD often engage in risky behaviors, such as dangerous driving, substance abuse and gambling. Current behavioral economy theories differentiate between risk perception and risk attitude. This study aims to measure both risk taking and risk perception in adults with and without ADHD. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ADHD
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to Nov 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults with ADHD
Who may be able to join
- clinical diagnosis of ADHD
Who cannot join
- any neurological disorder
- any psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
People with ADHD often engage in risky behaviors, such as dangerous driving, substance abuse and gambling. Current behavioral economy theories differentiate between risk perception and risk attitude. This study aims to measure both risk taking and risk perception in adults with and without ADHD. It is hypothesized that people with ADHD show decreased risk perception, accounting for their risky behavior. In contrast, it is hypothesized that people with ADHD do not show increased risk attitude, namely, they are not risk seeking.
Read the detailed description
INTRODUCTION:
People with ADHD are found to be engaged in risky behavior and tend to take risks such as dangers driving, substance abuse, gambling and more. These tendencies are in line with findings of poor decision making in individuals with ADHD. Even though none of the existing theories of ADHD manage to explain the full spectrum of decision making among ADHD, yet this population interpreted as risk seekers regardless causative correlation that link the disorder to risk taking behavior. Studies regarding decision making under uncertainty have uncovered common patterns of behavior that are inconsistent with the grasp that individuals with ADHD are risk seekers. First, studies that used gambling tasks showed that subjects with ADHD bet on smaller wages than non ADHD subjects. Second, when subjects with ADHD confronted with risky options that showed similarity in its expected value or that the expected value was beneficial compared to the safe one, they did not choose the risky options. Surprisingly, when the risky options did not carry any gain or benefit they tend to choose the risky options upon the beneficial or safer ones. Third, subjects with ADHD who preformed explicit pure risk seeking tasks under two conditions, with and without feedback, differ from control group only in the with feedback condition and were conservative in choosing risky alternatives. All of the above questions upon the risk perception of people with ADHD in more skeptical light and is being researched in this study in a direct and more comprehensive way.
METHODS:
Participants:
Two hundred adults with and with out ADHD will be recruited through addressing to undergraduate students at the Hebrew University and Talpiot Collage in Israel, who will be enrolled in special education course for teachers, and through addressing work colleagues.
All participants will complete the following questionnaire:
ADHD Adult Self Report Scale (ASRS-v1.1) in order to measure the severity of ADHD symptoms.
Domain-specific Risk-Taking (DOSPERT): The subjects will be asked to complete a paper-and-pencil questionnaire in groups of 5-10 individuals or in private.of the DOSPERT questionnaire consisted of a total set of 30 items assessing 3 scales (risk taking, risk perception and expected benefits) in five domains of risk: financial, health/safety, recreational, ethics, and social, 6 items in each domain. The set of 30 items was presented three times in counterbalanced order.
The Hebrew version of the DOSPERT scale was developed for this study using the method of back-translation. Internal consistency for the 3 measures was good. Cronbach's alpha was 0.85, 0.83 and 0.86, for Risk Taking, Risk Perception and Expected Benefit perception, respectively.
Hypothesis:
We predict that: (a) higher level of ADHD symptoms will be associated with higher risk taking ; (b) lower risk perception and higher benefit perception will be associated with higher risk taking ; (c) higher level of ADHD symptoms will be associated with lower risk perception and higher benefit perception ; (d) risk and benefit perceptions will mediate the relation between level of ADHD symptoms and risk taking.
Analysis:
Three measures will be analyzed: Risk Taking (defined as the willingness to engage in a risky activity as a function of its perceived riskiness), Risk Perception (defined as the reported level of risk taking), and Expected Benefits (define as the benefit responders expect to obtain from engaging in each risky behavior). Correlations with the ASRS scores will be examined. A mediation analysis will be conducted in order to examine the role of risk and benefit perception as potential mediator of ADHD-related risk taking.
- 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 |
|---|---|---|
| adults with ADHD | adults with ADHD, without neurological and psychiatric comorbidities | |
| controls | people without ADHD, with no neurological and psychiatric disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Domain-specific Risk-Taking questionnaire
Subjects are given the questionnaire once
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2014
- Primary completionNov 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
- 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 Pollak, PhD, Principal investigator, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994694
- Sponsor's protocol ID
- riskperception.ctil
- Status last verified
- Jul 2015
- First submitted
- 17 Nov 2013
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Perception in Adults With Attention Deficit and Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01994694
- Acronym / sponsor ID
- riskperception.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
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 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.
People with ADHD often engage in risky behaviors, such as dangerous driving, substance abuse and gambling. Current behavioral economy theories differentiate between risk perception and risk attitude. This study aims to measure both risk taking and risk perception in adults with and without ADHD. It is hypothesized that people with ADHD show decreased risk perception, accounting for their risky behavior. In contrast, it is hypothesized that people with ADHD do not show increased risk attitude, namely, they are not risk seeking.
Detailed description
INTRODUCTION:
People with ADHD are found to be engaged in risky behavior and tend to take risks such as dangers driving, substance abuse, gambling and more. These tendencies are in line with findings of poor decision making in individuals with ADHD. Even though none of the existing theories of ADHD manage to explain the full spectrum of decision making among ADHD, yet this population interpreted as risk seekers regardless causative correlation that link the disorder to risk taking behavior. Studies regarding decision making under uncertainty have uncovered common patterns of behavior that are inconsistent with the grasp that individuals with ADHD are risk seekers. First, studies that used gambling tasks showed that subjects with ADHD bet on smaller wages than non ADHD subjects. Second, when subjects with ADHD confronted with risky options that showed similarity in its expected value or that the expected value was beneficial compared to the safe one, they did not choose the risky options. Surprisingly, when the risky options did not carry any gain or benefit they tend to choose the risky options upon the beneficial or safer ones. Third, subjects with ADHD who preformed explicit pure risk seeking tasks under two conditions, with and without feedback, differ from control group only in the with feedback condition and were conservative in choosing risky alternatives. All of the above questions upon the risk perception of people with ADHD in more skeptical light and is being researched in this study in a direct and more comprehensive way.
METHODS:
Participants:
Two hundred adults with and with out ADHD will be recruited through addressing to undergraduate students at the Hebrew University and Talpiot Collage in Israel, who will be enrolled in special education course for teachers, and through addressing work colleagues.
All participants will complete the following questionnaire:
ADHD Adult Self Report Scale (ASRS-v1.1) in order to measure the severity of ADHD symptoms.
Domain-specific Risk-Taking (DOSPERT): The subjects will be asked to complete a paper-and-pencil questionnaire in groups of 5-10 individuals or in private.of the DOSPERT questionnaire consisted of a total set of 30 items assessing 3 scales (risk taking, risk perception and expected benefits) in five domains of risk: financial, health/safety, recreational, ethics, and social, 6 items in each domain. The set of 30 items was presented three times in counterbalanced order.
The Hebrew version of the DOSPERT scale was developed for this study using the method of back-translation. Internal consistency for the 3 measures was good. Cronbach's alpha was 0.85, 0.83 and 0.86, for Risk Taking, Risk Perception and Expected Benefit perception, respectively.
Hypothesis:
We predict that: (a) higher level of ADHD symptoms will be associated with higher risk taking ; (b) lower risk perception and higher benefit perception will be associated with higher risk taking ; (c) higher level of ADHD symptoms will be associated with lower risk perception and higher benefit perception ; (d) risk and benefit perceptions will mediate the relation between level of ADHD symptoms and risk taking.
Analysis:
Three measures will be analyzed: Risk Taking (defined as the willingness to engage in a risky activity as a function of its perceived riskiness), Risk Perception (defined as the reported level of risk taking), and Expected Benefits (define as the benefit responders expect to obtain from engaging in each risky behavior). Correlations with the ASRS scores will be examined. A mediation analysis will be conducted in order to examine the role of risk and benefit perception as potential mediator of ADHD-related risk taking.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adults with ADHD | – | –adults with ADHD, without neurological and psychiatric comorbidities |
| controls | – | –people without ADHD, with no neurological and psychiatric disorders |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with ADHD
Key inclusion criteria (1 listed)
- clinical diagnosis of ADHD
Key exclusion criteria (2 listed)
- any neurological disorder
- any psychiatric disorder
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
Domain-specific Risk-Taking questionnaire
Time frame: 1 day
Subjects are given the questionnaire once
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 18 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
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 2 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 18 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?
Domain-specific Risk-Taking questionnaire (time frame: 1 day). 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 18 Nov 2015.