Quality of Life Clinical Trial
Official title:
Inter-Venture: A Cluster Randomized Controlled Trial Investigating the Effect of School-based Personality-targeted Interventions and Collaborative Youth Mental Health Care
Mental health problems affect 10-20% of children and adolescents worldwide, with half of
affected youth experiencing problems by the age of 14. Despite the early onset of mental
health problems, evidence-based prevention and early intervention programs remain scarce. If
left untreated, early-onset mental health problems can progress to become severe or chronic
conditions, and incur significant medical and societal costs.
The current project proposes an integrated screening and intervention model that was
developed involving active youth, family and community engagement. This project, known as
Inter-Venture, focuses on reducing barriers to youth mental health care and promoting early
screening and intervention by fostering collaboration between school and community-based
services providers. The Inter-Venture project is being conducted in the Montreal area
(Canada), and consists of three intervention modalities. Namely, 1) systematic school-based
screening and personality-targeted interventions for students most at risk of mental health
problems and substance misuse (the Preventure program); 2) a parent program designed to
strengthen parenting skills and to improve the management of child behavior problems
(Cope/EQUIPE program); 3) integrated services provided by a multidisciplinary team of
professionals (referred to as Inter-Action) for youth with significant symptoms of mental
health problems, substance misuse and/or psychosocial difficulties. The intervention model
involves knowledge transfer to boost capacity-building and improve the provision and
sustainability of evidence-based interventions in community settings.
The primary goal of the Inter-Venture trial is to assess the potential effect of the
school-based targeted interventions and collaborative care in the prevention, early detection
and reduction of mental health problems, substance misuse and psychosocial difficulties among
young people. The secondary goal is to assess the effect of interventions on school
performance and whether the interventions can protect cognitive functions that may be
negatively affected by early-onset substance use and mental health problems, and promote
cognitive development through the prevention of these difficulties.
The Inter-Venture Trial is a cluster-randomised controlled trial of three intervention
modalities developed involving active youth, family and community engagement in the Montreal
area: (i) Systematic school-based screening and early personality-targeted interventions for
students most at risk of mental health problems and substance misuse (Preventure program);
(ii) Community-based parent training program and (iii) Timely and integrated services
provided by a multidisciplinary team of professionals (Inter-Action).
The trial will assess the potential effects of some of the components of the intervention
model in 45 secondary schools that will be randomly assigned to two intervention conditions
(receiving Inter-Action services and the parent training program in addition to Preventure or
receiving the Preventure program and the parent training program) and a control arm that will
receive treatment as usual. Schools will be matched on their baseline socio-economic status.
Approximately 4000 students in participating schools will be invited to complete annual
assessments for 5 consecutive years from grade 7 to grade 11.
Based on their scores on the Substance Use Risk Profile Scale, at-risk students will be
identified and invited to participate in the Preventure program in the first year of the
trial. Parents of grade 7 students reporting discord at home on the Alabama parenting
questionnaire will be invited to participate to the parent program. Participating students
with clinically significant internalizing and externalizing problems will be invited to
receive Inter-Action services. Internalizing and externalizing problems will be assessed
using self-report measures such as the Patient Health Questionnaire for Adolescents, the
Strengths and Difficulties Questionnaire, the screening tool for the detection of alcohol and
drug problems in adolescents (DEP-ADO) and the development and well-being assessment (DAWBA).
Primary outcomes will be the likelihood of reporting a significant level of mental health
problems, behavioral problems, substance misuse and poor quality of life among participating
youth.
Secondary outcomes will include the severity of the symptoms of mental health and substance
use problems, school performance, time to received treatment, time in treatment, quality of
care, cognitive functioning and other psychosocial outcomes.
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