Clinical trial NCT02919215: Teacher Help for Children and Youth With Mental Health Disorders
Official title: Teacher Help: Novel Technologies for Meeting the Immediate Needs of Youth With Mental Health Disorders in Canada
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorder
Learning Disabilities
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 550
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Teachers are increasingly faced with classrooms of students whose needs require support far beyond what traditional teacher-training programs prepare educators to provide. The presence of students with greater challenges in classrooms is due in part to the move to a full inclusion model of education and also to the rising epidemic of mental health disorders in youth. Mental health problems affect up to one million Canadian youth and their families. However, few of these individuals (\~20%) receive the support they need (Kirby, 2013; Kutcher \& McLuckie, 2013). The Teacher Help research team along with industry partner, Velsoft, and key knowledge user, Nova Scotia Department of Education and Early Childhood Development, will address this barrier by developing, evaluating, and commercializing a sustainable eHealth resource for teachers. Teacher Help is an online program that assists teachers in providing evidence-based interventions to students in grades 1-12 with mental health disorders in the classroom. The program allows teachers in a typical classroom setting to access information and expert-coach and peer support when they need it, so they can intervene early in order to reduce the negative consequences of mental health disorders in youth. Currently three modules (Attention-Deficit/Hyperactivity Disorder \[ADHD\], Autism Spectrum Disorder \[ASD\], and Learning Disabilities \[LD\]) are at different stages in the innovation pipeline. The investigators will test whether teachers make good use of this program and whether it is effective in improving mental health outcomes among children and youth both at school and at home. The investigators will also study whether the program changes teacher's attitudes toward children and youth with these disorders. The investigators will provide information to the Department of Education on how to use this program. This approach will help ensure that the program will continue after the research study ends. To the Teacher Help team's knowledge Teacher Help is the first and only research-validated eHealth program directly targeting teachers to help them intervene with children and youth who have mental health disorders, thus allowing Canada to take a lead in eHealth as applied to a school context.

Detailed description: Phase 1: Development of the online Teacher Help program. The Teacher Help research team will develop content for three modules (ADHD, ASD, and LD) so that these are evidence-based and appropriate for implementation in grade 1 - 12 classrooms across Canada. A Team Lead, in conjunction with the Principal Investigator, will develop each module with the support of Research Staff and advice from the larger Teacher Help team.

Each module will contain 6 sessions which will be made available to teachers as they complete each session (e.g., after a teacher completes session 1, session 2 will be made available). Each session should take approximately 1 hour to complete, including all worksheets and materials. Each session should take approximately one week to implement all activities; however, teachers can take up to two weeks to complete each session. Each session will provide factual information, strategies for implementation of best practices to address the specific mental health disorder in the classroom setting, and access to additional help and advice. Each module will typically include the following session topics: 1) An informative overview of the disorder and its treatments; 2) How teachers can help and the team approach; 3) The main intervention and how to implement this in the classroom; 4) Additional classroom strategies that may be helpful in addressing the core symptoms of the disorder; 5) Additional needs of students with the disorder and how to help; 6) Wrapping up the program and planning for the future.

Each session will provide strategies to help support teachers in their implementation of the information provided (e.g., confirmation and discussion of the challenges faced in implementing these strategies, self-help tips). The program contains text and photo information, selected videos to further explain certain concepts, as well as worksheets and supplemental materials to further engage teachers in interactive learning. The intervention program will be conceptually consistent across age groups in terms of the focus of each session; however, age-specific information will be included for two targeted grade groups: elementary school (typically grades 1- 6) and junior high and high school (typically grades 7-12; or grades that employ a rotary system where students have more than one teacher).

Many teachers will use the online information and guidance to implement the strategies without further support. A review of the literature supports this, and indicates that internet interventions can be successful without additional support. However, the Teacher Help program provides extra support whereby teachers can contact a collaborating psychologist via a messaging system internal to the program to seek direction and guidance during implementation of the program. Online collaborating psychologists will be psychologists (e.g., school/educational) working within the same school system/school as the teachers. Additionally, teachers will have access to peer-support through a Discussion Board function internal to the Teacher Help online platform.

Phase 2: Randomized Controlled Trial (RCT) to Evaluate the Effectiveness of the Intervention.The goal of this research is to evaluate the effectiveness of an online intervention designed to help teachers intervene with students with mental health disorders in typical grade 1 - 12 classroom settings. The intervention will be delivered across Canada, and the RCT will be coordinated through the implementation site at Halifax, NS. Assessments will be conducted at baseline as well as at 3 and 5 months post randomization. The primary goal is to assess the immediate impact (baseline vs. 3 months) of the intervention on teacher's attitudes toward students with these specific mental health disorders (i.e., ADHD, ASD, LD), as well as on student's mental health outcomes and quality of life as reported by guardians (e.g., parents) and teachers. Guardians will also be asked to report on how the intervention has impacted their family overall. Youth will also be asked to report on the impact of the intervention on themselves. Guardians, teachers, collaborating psychologists, and youth will be asked to report on their satisfaction with the intervention, and psychologists will be asked to track their experience with the intervention as well as their fidelity to the program manuals. The secondary goal is to evaluate the longer-term impact (baseline, 3, and 5 months) of the intervention on teachers, guardians, psychologists, and students.

Research Design. The investigators will use a cluster RCT (chosen to reduce contamination among participants) design to evaluate the effectiveness of the intervention using a pragmatic RCT approach (i.e., only measures that are necessary to test the effectiveness of the intervention rather than the mechanisms of change will be used). For this cluster RCT the point of randomization will be the collaborating psychologist. However, randomization of a social unit will occur as the psychologist represents the participating school board, school, and a minimum of 12 teacher-student-guardian triads. Data collected at 3 and 5 months will assess the degree of maintenance of any initial intervention effects on teachers, students, and guardians. Consort 2010 guidelines will be adhered to when reporting the trial.

Randomization. After baseline, each collaborating psychologist will be randomized to either the wait-list group or to the intervention (Teacher Help) group. Randomization to the wait-list group means that the psychologist and their teacher-student-guardian triads are free to access other interventions during the study, but will not be given access to the Teacher Help program right away. Psychologists and their teacher-student-guardian triads assigned to the intervention arm will be given access to the Teacher Help intervention after baseline and will also be allowed to access other interventions during the intervention phase. Therefore participants in the intervention arm could be considered to be receiving the internet-intervention plus usual services.The investigators will use block randomized stratification. Stratification and blocking will control for variation in sociodemographic differences among the sites. Computer-generated block randomization will be developed into an electronic algorithm using randomize.net. Random allocation will be independent and concealed.

The project manager will be responsible for ensuring all eligible participants complete their baseline assessments. After baseline assessment, collaborating psychologists with eligible participants will be electronically randomized to the wait-list or intervention group. Psychologists and their teacher-student-guardian triads in the wait-list group will not have access to any Teacher Help sessions during the cluster RCT, but will have the opportunity to complete the Teacher Help program in September the following academic year if they so choose. Collaborating psychologists and their teacher-student-guardian triads assigned to the intervention group will be automatically directed to the intervention website after randomization. A Teacher Help team member (e.g., research assistant), who will be blind to randomization allocation, will contact participants in both groups to encourage completion of assessments (outcome measures). All teachers, students, and guardians will be asked to complete assessments at baseline, 3 months, and 5 months. Teachers, students, and guardians in the wait-list group will be notified to wait until someone contacts them for a 3-month follow-up and again at 5 months. Psychologists in the intervention group will be asked to complete a support log throughout the intervention phase, and complete a Client Satisfaction Questionnaire at 3-month follow-up. Collaborating psychologists in the wait-list group will not be required to complete any assessments.

The wait-list group will be provided access to the program in September the following academic year due to the timelines of the project (5-month follow-up of the RCT will occur at the end of the academic year). Additionally, there are several benefits to providing the intervention to the wait-list group at this time. These benefits include more time for wait-listed teachers to implement the intervention, intervention for students at the beginning of the academic year rather than at the end, and increased reach of the program. Increased reach of the program will be achieved by providing access to the Teacher Help program to teachers recruited to participate in the cluster RCT the previous academic year as well as to the new (current academic year) teacher of the students recruited to participate in the cluster RCT the previous academic year. Wait-listed psychologists will also be given Teacher Help access codes for 10 additional teachers who may benefit from the program.

Participants. The investigators will aim to recruit 55 collaborating psychologists across Canada to partner with them in the cluster RCT. Psychologistss are those psychologists who work for or within school systems across Canada, and who are willing to act as an online support for teachers using the Teacher Help program. The investigators will collaborate with the psychologists to recruit enough participants to have 660 teacher-student-guardian triads across Canada. The goal will be to have 220 teacher-student-guardian triads per Teacher Help module (i.e., ADHD, ASD, and LD). Psychologists will be asked to recruit a minimum of 12 classroom teachers within their assigned schools to participate. A student of each teacher and one of his or her guardians (e.g., parents) need to agree to participate as well. As such, each psychologist will work with 12 teacher-student-guardian triads. Overall, the goal will be to recruit approximately 715 participants for the final assessment.

Inclusion and Exclusion criteria for this study are individualized for each group of participants. However, all participants need to be within Canada, as well as have access to an internet connection and an email address. Please see the Eligibility section to see the criteria pertaining to each different group.

Recruitment. Utilizing the Teacher Help team's Health Care Innovation Community (HCIC), the investigators will recruit psychologists to partner with them on the cluster RCT. Psychologists will be asked to recruit a minimum of 12 classroom teachers associated with their schools who teach grades 1 to 12. A student of each teacher and one of his or her guardians (e.g., parents) both need to agree to participate as well. A range of recruitment strategies, including word of mouth through our Advisory Board and Partners, website advertisements on our HCIC's websites, particularly our end-user websites (Canadian ADHD Resource Alliance \[CADDRA\], Learning Disabilities Association of Canada \[LDAC\], and Autism Canada), online and printed newsletters, and social media. The investigators will aim for at least one collaborating psychologist per province.

Assessments. All assessments will be completed online. Assessments will be conducted at baseline, and at 3 and 5 months post-randomization. For guardians and teachers, assessments at baseline will take approximately 40 minutes to complete and at 3 and 5 months will take about 30 minutes to complete. For those students who are able to complete assessments, questionnaires should take approximately 30 minutes at Baseline and 20 minutes at 3-and-5-month follow-up to complete. For collaborating psychologists in the intervention arm, the support log should take approximately 15 minutes to complete each week, and the Client Satisfaction Questionnaire should take approximately 5-10 minutes to complete at 3-month follow-up. A Teacher Help team member, blinded to randomization, will send an email to participants at the appropriate time requesting they complete the assessments and will follow up by email and/or telephone to answer any questions and encourage completion of the forms.

Eligibility criteria: Inclusion and Exclusion criteria for this study are individualized for each group of participants. Please see below for the eligibility criteria pertaining to each different group.

Inclusion Criteria

1. School Boards and Schools: a) Are public schools within Canada, b) Willing to participate in a research study, c) Completed a research ethics review, if needed, and d) Have students with ADHD, ASD, or LD who attend the school in typical classroom settings
2. Collaborating psychologists: a) Work within a public school system in Canada, b) Are willing to provide online support to classroom teachers throughout the implementation of the Teacher Help program, c) Have the ability to recruit a minimum of 12 classroom teachers who teach grades 1 to 12 to participate. A student of each teacher and one of his or her guardians (e.g., parents) both need to agree to participate as well, and d) Are licensed/registered psychologists OR are on the candidate register OR are psychological associates OR are certified school psychologists
3. Teachers: a) Work in a typical classroom setting in grades 1-12 with English as the language of instruction, b) Currently have one student in their classroom with ADHD, ASD, or LD who they would like to help by using this program, and c) The student and their guardian have agreed to participate
4. Guardians (e.g., parents): a) Have a child with ADHD, ASD, or LD whose teacher is willing to participate in the research study.
5. Students: a) Have a diagnosis of ADHD, ASD, or LD provided by a psychologist or physician, and b) Spend a significant portion of their class time inside the typical classroom (i.e., at least 2/3 of their day is spent in their classroom)

Exclusion Criteria

1. Any of the possible participating groups are not within Canada
2. Participants do not have access to an internet connection and/or email address

Primary outcomes:
measure: Teacher Demographic Questionnaire (author made)
timeFrame: Baseline
measure: Change in Teacher Attitudes at 3 and 5 months (Kos, 2008)
timeFrame: Baseline, 3 months, and 5 months
measure: Willingness to Pay Questionnaire
timeFrame: 3 months
measure: Change in Strengths and Difficulties Questionnaire at 3 and 5 months (SDQ; Goodman, 2001)
timeFrame: Baseline, 3 months, and 5 months
measure: Change in Pediatric Quality of Life Inventory at 3 and 5 months (PedsQL-4; Varni et al., 1999)
timeFrame: Baseline, 3 months, and 5 months
measure: Client Satisfaction Questionnaire (Attkisson & Swick, 1990)
timeFrame: A 3 months
measure: Collaborating Psychologist Support Log (author-made)
timeFrame: Through intervention phase, approximately 5 months
measure: Youth Satisfaction Measure (author-made)
timeFrame: At 3 months
measure: Parent Demographic Questionnaire (author-made)
timeFrame: Baseline
measure: Change in Treatment Utilization at 3 and 5 months
timeFrame: Baseline, 3 months, and 5 months
measure: Change in The Beach Center Family Quality of Life Scale at 3 and 5 months (Hoffman et al., 2006)
timeFrame: Baseline, 3 months, and 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Penny V Corkum, PhD
role: PRINCIPAL_INVESTIGATOR
References: