- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03725371
Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli
October 29, 2018 updated by: Jean Liu, Yale-NUS College
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
133
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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).
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate
Time Frame: 7 minutes
|
For Trier Social Stress Task
|
7 minutes
|
Skin Conductance Response
Time Frame: 4 minutes
|
For loud sound
|
4 minutes
|
Skin Conductance Response
Time Frame: 4 minutes
|
For threatening photograph
|
4 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2011
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
October 29, 2018
First Submitted That Met QC Criteria
October 29, 2018
First Posted (Actual)
October 31, 2018
Study Record Updates
Last Update Posted (Actual)
October 31, 2018
Last Update Submitted That Met QC Criteria
October 29, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YNC-SASSI-Quanti-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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