Autism Spectrum Disorder Clinical Trial
Official title:
Teacher Help: Novel Technologies for Meeting the Immediate Needs of Youth With Mental Health Disorders in Canada
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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