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Integrated Prevention and Collaborative Care for Youth Mental Health

Primary Purpose

Mental Disorders, Substance-Related Disorders, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Preventure program
Equipe program
Inter-Action services
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Disorders focused on measuring Mental health problems, Substance misuse, Psychosocial difficulties, Youth

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

School inclusion criteria :

- Public or private schools offering regular courses from grade 7 to grade 11.

Student inclusion criteria:

  • Being in grade 7 at baseline
  • Students' assent to participate
  • Parental passive or active consent for students' participation

Parent inclusion criteria

  • Being a parent of grade 7 students in a school participating in the parent training program
  • Active consent to participate in the study

Exclusion Criteria:

  • Schools where the majority of students are coded as special needs students will not be included since the interventions are not adapted to their specific needs

Sites / Locations

  • CHU Sainte-Justine Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Preventure, Equipe and Inter-Action

Preventure program and Equipe program

Control

Arm Description

Preventure program, Equipe program and Inter-Action services: Early personality-targeted interventions for students most at risk of mental health problems and substance misuse (Preventure program), parent program mainly for parents of high risk youth, especially those reporting discord at home (Equipe program) and integrated services for youth with significant internalizing and externalizing problems (Inter-Action services).

Early personality-targeted interventions for students most at risk of mental health problems and substance misuse (Preventure program) and parent program mainly for parents of high risk youth, especially those reporting discord at home (Equipe program)

Treatment as usual

Outcomes

Primary Outcome Measures

Reduced likelihood of having abnormal scores on three scales of the Strength and Difficulties Questionnaire ( conduct problems, emotional problems and hyperactivity scales) at the third and fifth year follow-up.
The Strengths and Difficulties Questionnaire is a self-report behaviour screening questionnaire used to assess various psychological symptoms and their impact in pediatric populations.
Reduced likelihood of significant alcohol and drug problems at the third and fifth year follow-up assessed by the DEP-ADO, a screening tool for the detection of alcohol and drug problems in adolescents.
The DEP-ADO is a self-report measure of age of onset, frequency and consequences of alcohol and illicit drug use in adolescents.
Self-reported quality of life at the third and fifth year follow-up assessed by the KIDSCREEN quality of life questionnaire.
The KIDSCREEN quality of life questionnaire is a self-report measure of four main aspects of adolescents' health-related quality of life: psychosocial functioning, school life, leisure and interpersonal relations.

Secondary Outcome Measures

Reduced likelihood of mental health problems at the third and fifth year follow-up the Patient Health Questionnaire for Adolescents
The Patient Health Questionnaire for Adolescents is a self-report measure of mental health and behavioral problems such anxiety, depression, and eating disorders among adolescents.
School attendance
Information on school attendance will be requested from schools
Academic performance
Grades will be requested to assess academic achievement.

Full Information

First Posted
March 10, 2017
Last Updated
December 6, 2017
Sponsor
St. Justine's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03114007
Brief Title
Integrated Prevention and Collaborative Care for Youth Mental Health
Official Title
Inter-Venture: A Cluster Randomized Controlled Trial Investigating the Effect of School-based Personality-targeted Interventions and Collaborative Youth Mental Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
September 14, 2021 (Anticipated)
Study Completion Date
December 14, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Substance-Related Disorders, Quality of Life
Keywords
Mental health problems, Substance misuse, Psychosocial difficulties, Youth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preventure, Equipe and Inter-Action
Arm Type
Experimental
Arm Description
Preventure program, Equipe program and Inter-Action services: Early personality-targeted interventions for students most at risk of mental health problems and substance misuse (Preventure program), parent program mainly for parents of high risk youth, especially those reporting discord at home (Equipe program) and integrated services for youth with significant internalizing and externalizing problems (Inter-Action services).
Arm Title
Preventure program and Equipe program
Arm Type
Experimental
Arm Description
Early personality-targeted interventions for students most at risk of mental health problems and substance misuse (Preventure program) and parent program mainly for parents of high risk youth, especially those reporting discord at home (Equipe program)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Preventure program
Intervention Description
Personality-targeted interventions conducted using manuals which incorporate psycho-educational, motivational enhancement therapy and cognitive-behavioural components. They include real life 'scenarios' shared by local youth with similar personality profiles. In the first session, participants are guided in a goal-setting exercise, designed to enhance motivation to change behaviour. Psycho-educational strategies are then used to teach participants about the target personality variable and associated problematic coping behaviours like avoidance, interpersonal dependence, aggression, risky behaviours and substance misuse.
Intervention Type
Behavioral
Intervention Name(s)
Equipe program
Intervention Description
Parent training program designed to be delivered in community settings accessible to large groups of parents of 13 to 18 year olds. It uses a coping modeling problem solving process in which parents are the key players in developing problem solving strategies. Parents participate in group workshops with themes related to communication, conflict resolution, cooperative transitions, negotiating, house rules, monitoring, consequences for serious problems and problem solving. Parents are guides to establish solutions to common problems. Readings and videotapes are used in the workshops to guide parents in identifying common challenges in child management, parenting errors, discussing possible consequences and alternative strategies as well as rationales supporting these strategies.
Intervention Type
Behavioral
Intervention Name(s)
Inter-Action services
Intervention Description
An intervention model designed to provide integrated services for youth with significant symptoms of mental health problems, substance misuse and/or psychosocial difficulties. Young people with such difficulties will benefit from stepped and collaborative care involving interventions of varied intensity adapted to their needs and the severity of their problems. These will include cognitive behavioral therapy, motivational interviews, dialectic behavioral therapy and family interventions provided by multidisciplinary teams of professionals. A case navigator will be in charge of initiating service provision and ensuring a fast and smooth flow of information between indicated services providers.
Primary Outcome Measure Information:
Title
Reduced likelihood of having abnormal scores on three scales of the Strength and Difficulties Questionnaire ( conduct problems, emotional problems and hyperactivity scales) at the third and fifth year follow-up.
Description
The Strengths and Difficulties Questionnaire is a self-report behaviour screening questionnaire used to assess various psychological symptoms and their impact in pediatric populations.
Time Frame
Annual assessments for 5 years
Title
Reduced likelihood of significant alcohol and drug problems at the third and fifth year follow-up assessed by the DEP-ADO, a screening tool for the detection of alcohol and drug problems in adolescents.
Description
The DEP-ADO is a self-report measure of age of onset, frequency and consequences of alcohol and illicit drug use in adolescents.
Time Frame
Annual assessments for 5 years
Title
Self-reported quality of life at the third and fifth year follow-up assessed by the KIDSCREEN quality of life questionnaire.
Description
The KIDSCREEN quality of life questionnaire is a self-report measure of four main aspects of adolescents' health-related quality of life: psychosocial functioning, school life, leisure and interpersonal relations.
Time Frame
Annual assessments for 5 years
Secondary Outcome Measure Information:
Title
Reduced likelihood of mental health problems at the third and fifth year follow-up the Patient Health Questionnaire for Adolescents
Description
The Patient Health Questionnaire for Adolescents is a self-report measure of mental health and behavioral problems such anxiety, depression, and eating disorders among adolescents.
Time Frame
Annual assessments for 5 years
Title
School attendance
Description
Information on school attendance will be requested from schools
Time Frame
Annual assessments for 5 years
Title
Academic performance
Description
Grades will be requested to assess academic achievement.
Time Frame
Annual assessments for 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: School inclusion criteria : - Public or private schools offering regular courses from grade 7 to grade 11. Student inclusion criteria: Being in grade 7 at baseline Students' assent to participate Parental passive or active consent for students' participation Parent inclusion criteria Being a parent of grade 7 students in a school participating in the parent training program Active consent to participate in the study Exclusion Criteria: Schools where the majority of students are coded as special needs students will not be included since the interventions are not adapted to their specific needs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia J Conrod, PhD
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Sainte-Justine Research Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia J conrod, PhD
Phone
514-345-4931
Ext
4051
Email
patricia.conrod@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Olive Mukamana, M.Sc.
Phone
514-345-4931
Ext
7665
Email
olive.mukamana@recherche-ste-justine.qc.ca

12. IPD Sharing Statement

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Integrated Prevention and Collaborative Care for Youth Mental Health

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