NCT03725371

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

4 years

First QC Date

October 29, 2018

Last Update Submit

October 29, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Heart Rate

    For Trier Social Stress Task

    7 minutes

  • Skin Conductance Response

    For loud sound

    4 minutes

  • Skin Conductance Response

    For threatening photograph

    4 minutes

Interventions

No intervention was administered for the purpose of this study. Observations were carried out for all participants.

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Conduct DisorderAttention Deficit Disorder with HyperactivityOppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Daniel Fung

    Institute of Mental Health, Singapore

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Yale-NUS College and Adjunct Assistant Professor, Duke-NUS Graduate Medical School

Study Record Dates

First Submitted

October 29, 2018

First Posted

October 31, 2018

Study Start

August 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 31, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share