Ignite Creation Date:
2024-05-06 @ 12:46 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01655615
Status:
UNKNOWN
Last Update Posted:
2016-10-31
First Post:
2012-03-14
Brief Title:
Does Delaying Adolescent Substance Use Lead to Improved Cognitive Function and Reduce Risk for Addiction
Sponsor:
St Justines Hospital
Organization:
St Justines Hospital
Study Overview
Official Title:
Co-venture A Cluster Randomized Trial Investigating the Effects of Selective Intervention on Adolescent Cognitive Development and Addiction
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Preventure Program is the first and only school-based alcohol and drug prevention program that has been shown to prevent onset and growth in alcohol and substance misuse in British and Canadian youth Unlike universal programs that tend to promote generic coping skills and balance normative attitudes around substance use this selected personality-targeted approach is based on a psychosocial model and validated by Dr Patricia Conrod and targets four personality-specific motivational pathways to substance misuse Hopelessness Anxiety Sensitivity Impulsivity and Sensation Seeking each associated with different motives for substance use drug use profiles and patterns of non-addictive psychopathology
As a primary goal of the Coventure project the investigators propose a long-term trial of this intervention strategy to examine how this evidence-based intervention can reduce onset of substance use disorders in young people and related secondary mental health academic and cognitive outcomes
As a secondary goal the investigators propose to use sensitive neuropsychological measures to examine how this evidence-based intervention can positively impact on cognitive development over the course of adolescence to tease apart some of the mechanisms involved in the causal pathway from early onset substance use to poor cognitive development and long-term addiction outcomes
As a primary goal of the Coventure project the investigators propose a long-term trial of this intervention strategy to examine how this evidence-based intervention can reduce onset of substance use disorders in young people and related secondary mental health academic and cognitive outcomes
As a secondary goal the investigators propose to use sensitive neuropsychological measures to examine how this evidence-based intervention can positively impact on cognitive development over the course of adolescence to tease apart some of the mechanisms involved in the causal pathway from early onset substance use to poor cognitive development and long-term addiction outcomes
Detailed Description:
This is a cluster randomized design in which 31 high schools across Montreal Canada will be randomly assigned to receive training and to deliver the program to two cohorts of Grade 7 students or to be trained and assisted in delivering the program to future Grade 7 cohorts Assessment of participating students will occur annually from September to May until the end of high school year Students will be assessed on personality substance use mental health and cognitive measures
The program involves delivering specialized coping skills group workshops to students when they are in the 7th or 8th grade About 45 of students in a given grade will be invited to participate in the workshops
The workshops will focus on motivating children to understand how their personality style leads to certain emotional and behavioural reactions They will be guided in learning cognitive behavioural skills on how to channel their strengths towards their long-term goals Four different workshops will be run focusing either on managing impulsivity sensation seeking anxiety sensitivity or negative thinking
The students will first be asked to participate in a 45-60 minutes survey asking them about their personality their strength and weaknesses their risk-taking behaviour and their learning style
Then if their school has been trained to deliver the program they might be invited to participate in two 90-minute workshops delivered at school during class time or lunch hour All children who agree to participate in the study will be invited to complete the same survey in each subsequent academic year for the next four years
Primary outcomes
1 Short-term delayed onset of alcohol and substance use up to two years post intervention
2 Long-term prevention of onset of substance use disorder at 5th year follow-up
Secondary intermediate outcomes are neuropsychological functions for which two hypotheses will be investigated regarding the possible effects of delaying early substance use
1 Global Effects Hypothesis substance use and binge drinking will have global harmful effects on cognition and interventions that successfully prevent substance use onset will result in global improvements in cognitive function in participants who received the intervention relative to those randomized to control condition
2 Critical Developmental Period Hypothesis the toxic effects of alcohol and drug use are developmentally specific so effects of interventions will be observed on cognitive processes that are maturing in adolescence namely executive functions and reward sensitivity after controlling for general intelligence quotient IQ and memory function following procedure described by Séguin et al 2004
Secondary outcomes will be measures of poor mental health and functional cognitive measures such as academic achievement and school drop-out
The program involves delivering specialized coping skills group workshops to students when they are in the 7th or 8th grade About 45 of students in a given grade will be invited to participate in the workshops
The workshops will focus on motivating children to understand how their personality style leads to certain emotional and behavioural reactions They will be guided in learning cognitive behavioural skills on how to channel their strengths towards their long-term goals Four different workshops will be run focusing either on managing impulsivity sensation seeking anxiety sensitivity or negative thinking
The students will first be asked to participate in a 45-60 minutes survey asking them about their personality their strength and weaknesses their risk-taking behaviour and their learning style
Then if their school has been trained to deliver the program they might be invited to participate in two 90-minute workshops delivered at school during class time or lunch hour All children who agree to participate in the study will be invited to complete the same survey in each subsequent academic year for the next four years
Primary outcomes
1 Short-term delayed onset of alcohol and substance use up to two years post intervention
2 Long-term prevention of onset of substance use disorder at 5th year follow-up
Secondary intermediate outcomes are neuropsychological functions for which two hypotheses will be investigated regarding the possible effects of delaying early substance use
1 Global Effects Hypothesis substance use and binge drinking will have global harmful effects on cognition and interventions that successfully prevent substance use onset will result in global improvements in cognitive function in participants who received the intervention relative to those randomized to control condition
2 Critical Developmental Period Hypothesis the toxic effects of alcohol and drug use are developmentally specific so effects of interventions will be observed on cognitive processes that are maturing in adolescence namely executive functions and reward sensitivity after controlling for general intelligence quotient IQ and memory function following procedure described by Séguin et al 2004
Secondary outcomes will be measures of poor mental health and functional cognitive measures such as academic achievement and school drop-out
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None