Conduct DisorderNCT02998073
Investigating Psychosocial Intervention Treatment Response in Justice-Involved Youth With Conduct Disorder
A study testing Stop, Now and Plan in people with Conduct Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 11 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Conduct Disorder
- What is being tested?
- Stop, Now and Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2017to 11 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Historical diagnosis of CD as per the K-SADS, which will be corroborated by DSM-5 criteria obtained by clinical assessment, and a CBCL, externalizing sub-score of 70 and above.
- No history of psychiatric illness as assessed by the Kiddi - Schedule for Affective Disorders and Schizophrenia Present and Lifetime version (K-SADS)
- No history of criminal justice system involvement.
Who cannot join
- Serious, unstable medical condition that precludes safe participation in the study
- History of neurological or endocrine disorder
- Any contraindication to safe MRI scanning, including claustrophobia
- Psychotic or bipolar disorder
- Current drug use measured by urinalysis
- Full-scale IQ of 80 or lower (cut-off for borderline intellectual functioning) measured using the Wechsler Abbreviated Scales of Intelligence - 2nd Edition (WASI-II)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple Biomarker Approach to Investigating Psychosocial Intervention Treatment Response in Justice-Involved Youth With Conduct Disorder
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.
Read the 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.
- Conditions
- Conduct Disorder
- Being tested
- Stop, Now and Plan
- Medical subject headings
- Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stop, Now and PlanBehavioural
SNAP program was developed to target justice-involved youth (6 years and older) who have problems with aggression, CD, and/or gang affiliation. SNAP focuses on engaging youth in interesting and creative learning modules by providing real life scenarios designed to improve self-control, impulsive behaviors, decision-making skills, and pro-social skills. SNAP treatment is delivered over a 13-week period.
| Study group | Role | What they receive |
|---|---|---|
| Conduct Disorder | Experimental | Participants are justice-involved youth with conduct disorder. Participants will receive Stop, Now and Plan (SNAP) psychosocial intervention. Receives: Behavioral: Stop, Now and Plan |
| Control | No intervention | Participants are healthy males. Participants receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline: blood-oxygen-level dependent (BOLD) activation of anterior cingulate cortex as measured by functional magnetic resonance imaging
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.)
Measured: Measured before and after the 13-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start15 Oct 2017
- Primary completion5 Feb 2020
- Study completion11 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduct DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Responsible party
- Principal investigator, Nathan Kolla, Centre for Addiction and Mental Health
- Investigators
- Nathan Kolla, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998073
- Sponsor's protocol ID
- 0702016
- Status last verified
- Aug 2021
- First submitted
- 14 Dec 2016
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Biomarker Approach to Investigating Psychosocial Intervention Treatment Response in Justice-Involved Youth With Conduct Disorder
- ClinicalTrials.gov ID
- NCT02998073
- Acronym / sponsor ID
- 0702016
- Conditions
- Conduct Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conduct Disorder | Experimental | Behavioral: Stop, Now and PlanParticipants are justice-involved youth with conduct disorder. Participants will receive Stop, Now and Plan (SNAP) psychosocial intervention. |
| Control | No intervention | –Participants are healthy males. Participants receive no intervention. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Historical diagnosis of CD as per the K-SADS, which will be corroborated by DSM-5 criteria obtained by clinical assessment, and a CBCL, externalizing sub-score of 70 and above.
- No history of psychiatric illness as assessed by the Kiddi - Schedule for Affective Disorders and Schizophrenia Present and Lifetime version (K-SADS)
- No history of criminal justice system involvement.
Key exclusion criteria (6 listed)
- Serious, unstable medical condition that precludes safe participation in the study
- History of neurological or endocrine disorder
- Any contraindication to safe MRI scanning, including claustrophobia
- Psychotic or bipolar disorder
- Current drug use measured by urinalysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stop, Now and PlanSNAP program was developed to target justice-involved youth (6 years and older) who have problems with aggression, CD, and/or gang affiliation. SNAP focuses on engaging youth in interesting and creative learning modules by providing real life scenarios designed to improve self-control, impulsive behaviors, decision-making skills, and pro-social skills. SNAP treatment is delivered over a 13-week period. | Behavioural | Conduct Disorder |
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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Kolla, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stop, Now and Plan in people with Conduct Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.