Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli

• Sponsor: Yale-NUS College (Other)
• Overall Status: Completed
• CT.gov ID: NCT03725371
• Collaborator: (none)
• Enrollment: 133
• Actual Duration (Months): 48

Study Details

Study Description

Brief 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). 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.

Condition or Disease	Intervention/Treatment	Phase
Conduct Disorder; ADHD; Oppositional Defiant Disorder	Other: No intervention was administered for the purpose of this study.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 133 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli
• Actual Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Outcome Measures

Primary Outcome Measures

1. Heart Rate [7 minutes]

   For Trier Social Stress Task

2. Skin Conductance Response [4 minutes]

   For loud sound

3. Skin Conductance Response [4 minutes]

   For threatening photograph

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects between ages 7 and 16 years

2. Subjects who fulfil all criteria for a DSM-IV diagnosis of ADHD, conduct disorder, or oppositional defiant disorder

3. Subjects with willingness to participate in a randomized, double-blind controlled trial

4. Subjects with complete written, informed parental consent and child assent

5. Subjects with IQ of 70 or more

Exclusion Criteria:

1. Subjects who have IQ in the below 70

2. Subjects who are younger than 7 years old or older than 16 years old

3. Those without written parental consent

4. Those with brain pathology such as serious head injury, epilepsy, etc.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yale-NUS College

Investigators

• Study Director: Daniel Fung, Institute of Mental Health, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jean Liu, Assistant Professor, Yale-NUS College and Adjunct Assistant Professor, Duke-NUS Graduate Medical School, Institute of Mental Health, Singapore
• ClinicalTrials.gov Identifier: NCT03725371
• Other Study ID Numbers: YNC-SASSI-Quanti-1
• First Posted: Oct 31, 2018
• Last Update Posted: Oct 31, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Disease; Aggression; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders

Study Results

No Results Posted as of Oct 31, 2018