Conduct DisorderNCT03725371
Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli
An observational study of Conduct Disorder and ADHD, run by Yale-NUS College.
Trial summary
This study investigates the psychophysiological correlations of aggression and response to aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder (CD) and/or attention-deficit/hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Conduct Disorder, ADHD, Oppositional Defiant Disorder
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Aug 2015
- How long will I take part?
- 1 Year
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: The study involves children and adolescents diagnosed with disruptive behaviour disorder (DBD, i.e. conduct disorder or oppositional defiant disorder) or attention deficit / hyperactivity disorder (ADHD, i.e. combined type or ADHD predominantly inattentive type or ADHD predominantly hyperactive-impulsive type).
Who may be able to join
- Subjects between ages 7 and 16 years
- Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or oppositional defiant disorder
- Subjects with willingness to participate in a randomized, double-blind controlled trial
- Subjects with complete written, informed parental consent and child assent
- Subjects with IQ of 70 or more
Who cannot join
- Subjects who have IQ in the below 70
- Subjects who are younger than 7 years old or older than 16 years old
- Those without written parental consent
- Those with brain pathology such as serious head injury, epilepsy, etc.
About this study
This study investigates the psychophysiological correlations of aggression and response to aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder (CD) and/or attention-deficit/hyperactivity disorder (ADHD). Data was gathered about participants' level of aggression through the Reactive-Proactive Aggression Questionnaire (RPQ). The stimuli that were presented to the participants included 1) a loud sound, 2) threatening photographs from the International Affective Picture System (IAPS), and 3) the Trier Social Stress Task (TSST). Participants' psychophysiological features of heart rate and galvanic skin conductance were measured and analyzed in relation to their RPQ scores and clinical diagnosis.
- Conditions
- Conduct Disorder, ADHD, Oppositional Defiant Disorder
- Being tested
- No intervention was administered for the purpose of this study.
- Medical subject headings
- Conduct Disorder, Attention Deficit Disorder with Hyperactivity, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was administered for the purpose of this study.Other
No intervention was administered for the purpose of this study. Observations were carried out for all participants.
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
For Trier Social Stress Task
Measured: 7 minutes
Skin Conductance Response
For loud sound
Measured: 4 minutes
Skin Conductance Response
For threatening photograph
Measured: 4 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study startAug 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduct DisorderStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yale-NUS College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Liu, Institute of Mental Health, Singapore
- Investigators
- Daniel Fung, Study director, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725371
- Sponsor's protocol ID
- YNC-SASSI-Quanti-1
- Status last verified
- Oct 2018
- First submitted
- 29 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli
- ClinicalTrials.gov ID
- NCT03725371
- Acronym / sponsor ID
- YNC-SASSI-Quanti-1
- Conditions
- Conduct Disorder, ADHD, Oppositional Defiant Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Yale-NUS CollegeUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Oct 2018 (actual)
- 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.
This study investigates the psychophysiological correlations of aggression and response to aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder (CD) and/or attention-deficit/hyperactivity disorder (ADHD). Data was gathered about participants' level of aggression through the Reactive-Proactive Aggression Questionnaire (RPQ). The stimuli that were presented to the participants included 1) a loud sound, 2) threatening photographs from the International Affective Picture System (IAPS), and 3) the Trier Social Stress Task (TSST). Participants' psychophysiological features of heart rate and galvanic skin conductance were measured and analyzed in relation to their RPQ scores and clinical diagnosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study involves children and adolescents diagnosed with disruptive behaviour disorder (DBD, i.e. conduct disorder or oppositional defiant disorder) or attention deficit / hyperactivity disorder (ADHD, i.e. combined type or ADHD predominantly inattentive type or ADHD predominantly hyperactive-impulsive type).
Key inclusion criteria (5 listed)
- Subjects between ages 7 and 16 years
- Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or oppositional defiant disorder
- Subjects with willingness to participate in a randomized, double-blind controlled trial
- Subjects with complete written, informed parental consent and child assent
- Subjects with IQ of 70 or more
Key exclusion criteria (4 listed)
- Subjects who have IQ in the below 70
- Subjects who are younger than 7 years old or older than 16 years old
- Those without written parental consent
- Those with brain pathology such as serious head injury, epilepsy, etc.
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 |
|---|---|---|
| No intervention was administered for the purpose of this study.No intervention was administered for the purpose of this study. Observations were carried out for all participants. | Other | – |
Primary outcome
Heart Rate
Time frame: 7 minutes
For Trier Social Stress Task
Skin Conductance Response
Time frame: 4 minutes
For loud sound
Skin Conductance Response
Time frame: 4 minutes
For threatening photograph
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 31 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Daniel Fung study director
Institute of Mental Health, Singapore
Questions about this trial
What is this clinical trial studying?
An observational study of Conduct Disorder and ADHD, run by Yale-NUS College.
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 5 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 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Heart Rate (time frame: 7 minutes). The study lists 3 primary outcomes in all. 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 31 Oct 2018.