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Clinical Trials/NCT02998073
NCT02998073
Completed
Not Applicable

A Multiple Biomarker Approach to Investigating Psychosocial Intervention Treatment Response in Justice-Involved Youth With Conduct Disorder

Centre for Addiction and Mental Health1 site in 1 country27 target enrollmentOctober 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Conduct Disorder
Sponsor
Centre for Addiction and Mental Health
Enrollment
27
Locations
1
Primary Endpoint
Change from baseline: blood-oxygen-level dependent (BOLD) activation of anterior cingulate cortex as measured by functional magnetic resonance imaging
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This research focuses on youth with conduct disorder (CD), and a history of violence. CD is a youth neurodevelopmental disorder that is commonly associated with criminality. Although psychosocial interventions that address impulsivity and self-control have been shown to be effective at helping promote prosocial behavior in patients with CD, the biological changes that occur as a result of treatment are not well understood. This study will explore changes in the brain function of the anterior cingulate cortex (ACC) in response to a common psychosocial intervention (Stop, Now and Plan). This study will contribute to our understanding of biological mechanisms involved in therapeutic gains among children with behavioural problems and youth offenders; therefore, it will inform further development of treatment programs for children/youth with impulsive behaviours.

Detailed Description

CD is a youth-limited neurodevelopmental disorder characterized by impulsivity and dysfunctional social behavior. CD is associated with increased risks of mortality, lower educational and occupational achievement, criminal behavior and other psychosocial difficulties, and hence presents a significant burden to society. Impulsivity is a prominent predictor of violence in CD. Treatment programs targeting impulsivity in CD have been shown to be effective at increasing pro-social functioning in CD, but the biological mechanisms that underpin these therapeutic gains are not well understood. Past research suggests that the ACC play a role in CD and impulsivity. This study explores biological and behavioral changes in response to Stop, Now and Plan (SNAP), a validated 13-week psychosocial intervention addressing impulsivity and self-control in youth. The main hypotheses are: (1) CD youth who respond to SNAP treatment will exhibit greater post-treatment ACC activation during an fMRI imaging task compared with their baseline, pre-treatment ACC activation. The secondary hypotheses are: (1) CD youth will exhibit lower ACC activation at baseline during an fMRI imaging task compared with the baseline ACC activation exhibited by typically developing youth.

Registry
clinicaltrials.gov
Start Date
October 15, 2017
End Date
August 11, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nathan Kolla

Principal Investigator

Centre for Addiction and Mental Health

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change from baseline: blood-oxygen-level dependent (BOLD) activation of anterior cingulate cortex as measured by functional magnetic resonance imaging

Time Frame: Measured before and after the 13-week program

Difference in ACC BOLD activation to commission errors (contrast of BOLD response during commission errors vs. BOLD response during correct hits) will be tested using a 2 (Session: pre-SNAP vs. post-SNAP) × 2 (Group: treatment responders vs. non-treatment responders) within subject, mixed model analysis of covariance (ANCOVA), controlling for the effect of age, to investigate the two-way interaction between session and group. (Note: Commission errors compose a measure produced by the Go/No-Go task.)

Study Sites (1)

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