Adolescent PsychiatryNCT01253993
Impaired Decision-making in Adolescents
An observational study of Adolescent Psychiatry and Antisocial Personality Disorders, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
There is clear evidence that aggressive behavior and disruptive behavior disorders (DBD) in middle childhood are associated with an increased risk for substance abuse in adolescence. However, the exact underlying mechanism of this increased risk is unknown. Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Psychiatry, Antisocial Personality Disorders, Substance-Related Disorders
- How many people
- 152 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2006to Sep 2007
- 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 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: DBD adolescents were recruited from judicial and forensic institutions. Healthy controls consisted of volunteers.
Who may be able to join
- Having a DISC diagnosis DBD
Who cannot join
- Having the DISC diagnosis Schizophrenia
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
About this study
Official title: Impaired Decision-making in Adolescents: A Vulnerability Factor for the Development of Substance Use and Abuse.
There is clear evidence that aggressive behavior and disruptive behavior disorders (DBD) in middle childhood are associated with an increased risk for substance abuse in adolescence. However, the exact underlying mechanism of this increased risk is unknown. It is likely that a biopsychological vulnerability in some aggressive children and children with DBD makes them liable to substance use and abuse. The investigators hypothesize that deficient decision making is such a biopsychological factor. In this study the investigators aim to test the latter hypothesis by investigating the decision making ability in a group of adolescents with DBD with and without substance use disorders. Decision-making is assessed with the IOWA Gambling Task (GT). This task mimics real-life situations in the way it factors uncertainty, reward and punishment. The GT is specifically designed to assess impaired decision-making in individuals who are unable to learn from their mistakes and make decisions that repeatedly lead to negative consequences. This characteristic may be common to individuals with externalizing disorders such as DBD, psychopathy, and substance use disorders.
Read the detailed description
This study consists of two substudies with adolescents in the age of 14-21 years. The first study group consist of adolescents with DBD with (n=30) and without (n=30) substance use disorders. These adolescents are recruited from orthopsychiatric, forensic psychiatric, and judicial institutions.
The second study group consists of a) ex-patients of the Utrecht Coping Power Program (UCPP)who previously participated to a follow-up study, and b) ex-patients who were treated as a child at an outpatient clinic of the UMC Utrecht. These latter groups were taken together and subdivided into a group with (n=30) and without (n=30) substance use problems.
For both studies healthy controls (n=80) are recruited. The investigators will start with healthy controls from earlier studies, and those are extented and will serve as control group for both studies.
- Keywords
- Disruptive Behavior Disorders, Substance abuse,, Iowa Gambling Task, Decision Making.
- Medical subject headings
- Antisocial Personality Disorder, Substance-Related Disorders, Attention Deficit and Disruptive Behavior Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startApr 2006
- Primary completionJun 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent PsychiatryStudies 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, National Institute on Drug Abuse (NIDA)
- Investigators
- Walter Matthys, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253993
- Sponsor's protocol ID
- 05-271
- Other IDs
- ZonMw 31100001, NIDA DA 16135
- Status last verified
- Dec 2010
- First submitted
- 2 Mar 2007
- Last updated
- 6 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ernst M, Grant SJ, London ED, Contoreggi CS, Kimes AS, Spurgeon L. Decision making in adolescents with behavior disorders and adults with substance abuse. Am J Psychiatry. 2003 Jan;160(1):33-40. doi: 10.1176/appi.ajp.160.1.33.
PubMed 12505799
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Decision-making in Adolescents: A Vulnerability Factor for the Development of Substance Use and Abuse.
- ClinicalTrials.gov ID
- NCT01253993
- Acronym / sponsor ID
- 05-271
- Keywords
- Disruptive Behavior Disorders, Substance abuse,, Iowa Gambling Task, Decision Making.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 6 Dec 2010 (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.
There is clear evidence that aggressive behavior and disruptive behavior disorders (DBD) in middle childhood are associated with an increased risk for substance abuse in adolescence. However, the exact underlying mechanism of this increased risk is unknown. It is likely that a biopsychological vulnerability in some aggressive children and children with DBD makes them liable to substance use and abuse. The investigators hypothesize that deficient decision making is such a biopsychological factor. In this study the investigators aim to test the latter hypothesis by investigating the decision making ability in a group of adolescents with DBD with and without substance use disorders. Decision-making is assessed with the IOWA Gambling Task (GT). This task mimics real-life situations in the way it factors uncertainty, reward and punishment. The GT is specifically designed to assess impaired decision-making in individuals who are unable to learn from their mistakes and make decisions that repeatedly lead to negative consequences. This characteristic may be common to individuals with externalizing disorders such as DBD, psychopathy, and substance use disorders.
Detailed description
This study consists of two substudies with adolescents in the age of 14-21 years. The first study group consist of adolescents with DBD with (n=30) and without (n=30) substance use disorders. These adolescents are recruited from orthopsychiatric, forensic psychiatric, and judicial institutions.
The second study group consists of a) ex-patients of the Utrecht Coping Power Program (UCPP)who previously participated to a follow-up study, and b) ex-patients who were treated as a child at an outpatient clinic of the UMC Utrecht. These latter groups were taken together and subdivided into a group with (n=30) and without (n=30) substance use problems.
For both studies healthy controls (n=80) are recruited. The investigators will start with healthy controls from earlier studies, and those are extented and will serve as control group for both studies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- DBD adolescents were recruited from judicial and forensic institutions. Healthy controls consisted of volunteers.
Key inclusion criteria (1 listed)
- Having a DISC diagnosis DBD
Key exclusion criteria (1 listed)
- Having the DISC diagnosis Schizophrenia
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
Not reported in the source record.
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 6 Dec 2010.
- Background: PubMed 12505799Ernst M, Grant SJ, London ED, Contoreggi CS, Kimes AS, Spurgeon L. Decision making in adolescents with behavior disorders and adults with substance abuse. Am J Psychiatry. 2003 Jan;160(1):33-40. doi: 10.1176/appi.ajp.160.1.33.
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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.
Walter Matthys, MD, PhD principal investigator
UMC Utrecht
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 Adolescent Psychiatry and Antisocial Personality Disorders, run by UMC Utrecht at 1 site in Netherlands.
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 6 Dec 2010. 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 Netherlands. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01253993, which also lists 1 linked publication.
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 6 Dec 2010.