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Integrated Prevention and Collaborative Care for Youth Mental Health

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ClinicalTrials.gov Identifier: NCT03114007
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Patricia Conrod, St. Justine's Hospital

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.


Condition or disease Intervention/treatment
Mental Disorders Substance-Related Disorders Quality of Life Behavioral: Preventure program Behavioral: Equipe program Behavioral: Inter-Action services

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Inter-Venture: A Cluster Randomized Controlled Trial Investigating the Effect of School-based Personality-targeted Interventions and Collaborative Youth Mental Health Care
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : September 14, 2021
Estimated Study Completion Date : December 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Preventure, Equipe and Inter-Action
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).
Behavioral: Preventure program
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.
Behavioral: Equipe program

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.

Behavioral: Inter-Action services
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.
Experimental: Preventure program and Equipe program
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)
Behavioral: Preventure program
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.
Behavioral: Equipe program

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.

No Intervention: Control
Treatment as usual



Primary Outcome Measures :
  1. 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. [ Time Frame: Annual assessments for 5 years ]
    The Strengths and Difficulties Questionnaire is a self-report behaviour screening questionnaire used to assess various psychological symptoms and their impact in pediatric populations.

  2. 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. [ Time Frame: Annual assessments for 5 years ]
    The DEP-ADO is a self-report measure of age of onset, frequency and consequences of alcohol and illicit drug use in adolescents.

  3. Self-reported quality of life at the third and fifth year follow-up assessed by the KIDSCREEN quality of life questionnaire. [ Time Frame: Annual assessments for 5 years ]
    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 :
  1. Reduced likelihood of mental health problems at the third and fifth year follow-up the Patient Health Questionnaire for Adolescents [ Time Frame: Annual assessments for 5 years ]
    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.

  2. School attendance [ Time Frame: Annual assessments for 5 years ]
    Information on school attendance will be requested from schools

  3. Academic performance [ Time Frame: Annual assessments for 5 years ]
    Grades will be requested to assess academic achievement.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114007


Locations
Canada, Quebec
CHU Sainte-Justine Research Center Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Patricia J conrod, PhD    514-345-4931 ext 4051    patricia.conrod@umontreal.ca   
Contact: Olive Mukamana, M.Sc.    514-345-4931 ext 7665    olive.mukamana@recherche-ste-justine.qc.ca   
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Patricia J Conrod, PhD St. Justine's Hospital

Responsible Party: Patricia Conrod, Full professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03114007     History of Changes
Other Study ID Numbers: RBC-CHU-2015
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patricia Conrod, St. Justine's Hospital:
Mental health problems
Substance misuse
Psychosocial difficulties
Youth

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Substance-Related Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Chemically-Induced Disorders