Integrated Prevention and Collaborative Care for Youth Mental Health

NCT03114007 | Unknown DMC

• 1 other identifier: RBC-CHU-2015
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorders; Substance-Related Disorders; Quality of Life

Keywords

Mental health problems; Substance misuse; Psychosocial difficulties; Youth

Outcome Measures

Primary Outcomes (3)

• 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.

  Annual assessments for 5 years

• 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.

  Annual assessments for 5 years

• 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.

  Annual assessments for 5 years

Secondary Outcomes (3)

• Reduced likelihood of mental health problems at the third and fifth year follow-up the Patient Health Questionnaire for Adolescents

  Annual assessments for 5 years

• School attendance

  Annual assessments for 5 years

• Academic performance

  Annual assessments for 5 years

Study Arms (3)

Preventure, Equipe and Inter-Action

EXPERIMENTAL

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; Behavioral: Equipe program; Behavioral: Inter-Action services

Preventure program and Equipe program

EXPERIMENTAL

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; Behavioral: Equipe program

Control

NO INTERVENTION

Treatment as usual

Interventions

Preventure program BEHAVIORAL

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.

Preventure program and Equipe program; Preventure, Equipe and Inter-Action

Equipe program BEHAVIORAL

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.

Preventure program and Equipe program; Preventure, Equipe and Inter-Action

Inter-Action services BEHAVIORAL

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.

Preventure, Equipe and Inter-Action

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Public or private schools offering regular courses from grade 7 to grade 11.
• Being in grade 7 at baseline
• Students' assent to participate
• Parental passive or active consent for students' participation
• Being a parent of grade 7 students in a school participating in the parent training program
• Active consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine Research Center

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Patricia J Conrod, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: April 14, 2017
• Study Start: April 24, 2017
• Primary Completion: September 14, 2021
• Study Completion: December 14, 2021
• Last Updated: December 8, 2017

Record last verified: 2017-12

Locations

CA (1)