Clinical Trial: Investigating Psychosocial Intervention Treatment Response in Justice-Involved Youth With Conduct Disorder

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary: This research focuses on justice-involved youth with conduct disorder (CD) and a history of violence. CD is a youth-limited 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 cortisol (a stress hormone) and the brain function of the anterior cingulate cortex (ACC) in response to a common psychosocial intervention (Stop, Now and Plan Youth Justice Model). This study will contribute to our understanding of biological mechanisms involved in therapeutic gains among youth offenders and thereby inform further development of treatment programs for justice-involved youth.

Detailed Summary:

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 cortisol and the ACC play a role in CD and impulsivity. This study explores biological and behavioral changes in response to Stop, Now and Plan Youth Justice Model (SNAP YJ), a validated 13-week psychosocial intervention addressing impulsivity and self-control in youth offenders

The main hypotheses are:

  1. CD youth who respond to SNAP YJ treatment will exhibit greater post-treatment ACC activation during an fMRI imaging task compared with their baseline, pre-treatment ACC activation.
  2. CD youth who respond to SNAP YJ treatment will exhibit a higher post-treatment cortisol awakening response (CAR) compared with their baseline, pre-treatment CAR.

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.
  2. CD youth will manifest a lower baseline CAR compared with the baseline CAR of typically developing youth.

Sponsor: Centre for Addiction and Mental Health

Current Primary Outcome: 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.)


Original Primary Outcome: Same as current

Current Secondary Outcome: Change from baseline: Saliva-derived cortisol [ Time Frame: Measured before and after the 13-week program ]

Saliva-derived cortisol will be analyzed using a time-resolved fluorescence immunoassay, and quantification of cortisol data will be achieved by calculating the area under the curve with respect to ground (AUCG), which is a validated method of measuring basal cortisol level derived from repeated measurements. Difference in AUCG with respect to CAR will be tested using a 2 (Session: pre-SNAP vs. post-SNAP) × 2 (Group: treatment responders vs. non-treatment responders) within subject, mixed model ANCOVA, controlling for the effect of age, to investigate the two-way interaction between session and group.


Original Secondary Outcome: Same as current

Information By: Centre for Addiction and Mental Health

Dates:
Date Received: December 14, 2016
Date Started: May 2017
Date Completion: February 2021
Last Updated: April 13, 2017
Last Verified: April 2017