Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000652875
Ethics application status
Approved
Date submitted
16/01/2021
Date registered
31/05/2021
Date last updated
10/02/2022
Date data sharing statement initially provided
31/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the feasibility, acceptability and effectiveness of a school-based educator intervention to identify & support children with emotional and behavioural difficulties: a pilot randomised controlled trial
Scientific title
Evaluating the feasibility, acceptability and effectiveness of a school-based educator intervention to identify & support children with emotional and behavioural difficulties: a pilot randomised controlled trial
Secondary ID [1] 303196 0
None
Universal Trial Number (UTN)
Trial acronym
HELP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotional difficulties 320324 0
Behavioural difficulties 321697 0
Condition category
Condition code
Mental Health 318241 318241 0 0
Anxiety
Mental Health 318242 318242 0 0
Learning disabilities
Mental Health 318243 318243 0 0
Other mental health disorders
Neurological 319435 319435 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Co-design focus groups
The co-design process will involve educator focus groups to discuss how best to design the intervention. Focus groups will occur at each intervention school at a time of the schools choosing. Study researchers will facilitate the focus groups. Participants will be provided information regarding similar models of collaboration, such as Project Echo and Communities of Practice, to guide their thinking in the co-design process. Specific focus will be placed upon the topics of interest regarding child health, development and well-being (e.g., learning difficulties, anxiety, attention deficit hyperactivity disorder), along with practicalities such as the grades of children included and the frequency of the seminar program sessions. Study researchers will facilitate the focus group sessions, which will involve a single session with each intervention school. The intervention will have fixed and flexible elements as indicated below.
Fixed elements - case discussions, focus on emotional and behavioural difficulties
Flexible elements - case discussion topics, frequency of case discussions

Seminar program
From the topics selected during the co-design focus groups, a seminar timetable will be constructed to best suit the educators at each intervention school. Seminars will occur at frequent intervals (approximately fortnightly) and video technology will be used to allow all participants to attend regardless of location. Any educators supporting the students involved in the intervention schools will be invited to attend, even if not the primary educator (e.g., Wellbeing Officer). A study clinician will present the evidence on the prevalence, clinical features, assessment and management of each topic with a focus on translating evidence-based practice into meaningful approaches for educators in the classroom. Where appropriate, external expertise will also be present to assist the group in best understanding the evidence and applying it to the case discussed. Participating educators will be invited to present a case-based student following each topic discussion, which will be a de-identified participating student in their class who they are supporting. The group will then discuss the best way to support the student presented and agree upon a plan which will be followed up in future discussions. Each seminar will be approximately 60 minutes in duration. The duration of the intervention will be 6 months.

Reflection focus groups
At completion of the intervention, I will conduct focus groups with intervention schools to assess the feasibility and acceptability of the model in regard to educator capacity to implement and benefit from the model. The sessions will explore what aspects of the project were beneficial and which require refinement. All participating educators within intervention schools will be invited to attend. As described in the initial focus group, sessions will be 90 minutes long at a time of each schools choosing. Attendee numbers are likely to be between 4-12 depending upon the individual school. Focus groups will occur within a fortnight of completion of the intervention.

Attendance will be recorded at each focus group and seminar program session to monitor adherence.
Intervention code [1] 319495 0
Early detection / Screening
Intervention code [2] 319496 0
Behaviour
Intervention code [3] 319497 0
Treatment: Other
Comparator / control treatment
Control schools will proceed with usual care with no support or services provided from the study outside of support completing surveys.
Control group
Active

Outcomes
Primary outcome [1] 326223 0
Feasibility as assessed by survey completion rate and seminar program attendance
Timepoint [1] 326223 0
Baseline and 6 month surveys
Fortnightly seminar program
Primary outcome [2] 327305 0
acceptability as assessed by study-specific questionnaire and focus group findings
Focus groups will be conducted at each school, be approximately 90 minutes long and involve all educators involved (2-12). The will be semi-structured, audio recorded and transcribed.
Timepoint [2] 327305 0
6 month survey
Reflection focus group discussion immediately after the intervention has been completed
Secondary outcome [1] 390584 0
Accuracy of educator identification of emotional and behavioural difficulties as assessed by surveys
- Strengths and difficulties questionnaire
- Study specific questionnaire
Timepoint [1] 390584 0
Baseline and 6 month surveys
Secondary outcome [2] 394521 0
Change in student emotional and behavioural difficulties as assessed by strengths and difficulties questionnaire
Timepoint [2] 394521 0
Baseline and 6 month surveys
Secondary outcome [3] 394522 0
Change in caregiver health service utilisation in the intervention versus usual care groups as assessed by study specific survey tools
Timepoint [3] 394522 0
Baseline and 6 month survey

Eligibility
Key inclusion criteria
School inclusion criteria
Government school
within City of Yarra or Wimmera Southern Mallee region
minimum of 60 students across grades 1, 2 & 3

Student inclusion criteria
completing grade 1, 2 or 3 in 2021
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
School exclusion criteria
secondary school
specialist school

Student exclusion criteria
Caregivers have insufficient English to complete the surveys & does not have access to an appropriate interpreter services to support completion of the survey

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A statistician not directly involved in the analysis of the trial results will prepare the randomisation schedule which will determine the allocation of each school.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician not directly involved in the analysis of the trial results will prepare the randomisation schedule. Randomisation will be stratified by region and tertile.
The Index of Community Socio-Educational Advantage (ICSEA) will be used to allocate each participating school into a relative tertiles. This will assist with later analysis and will in part account for confounding due to relative disadvantage in individual school student populations. Each tertile will contain 2 schools which will be randomly allocated to either a control or intervention school. Schools will also be categorised according to region. This is to ensure that the study accounts for a broad range of primary schools and to account for confounding during analysis.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The focus groups will be audio recorded and written documentation will also be taken during the sessions. Transcripts will be examined using inductive content analysis, which is a means of identifying and representing prominent themes in qualitative data through a process of open coding, the formulation of categories and abstraction. NVIVO 12 software will be used to support this analytic process.

For the pilot RCT I will conduct an intention-to-treat analysis at the level of the child. Educator and caregiver reported SDQ score differences between baseline and 4 and 8 months will be calculated in all intervention and control schools. Mean differences between the intervention and control groups will be then be compared using t-tests. To calculate effect sizes (ESs), change scores will be standardised to a mean of 0 and a SD of 1. ESs are considered as small, ~0.20 SD; moderate, ~0.50 SD; and large, ~0.80 SD. The single item measure will be dichotomised (thriving/coping versus struggling/always overwhelmed) and its sensitivity and specificity compared to the SDQ total scores for each student. if found to be sensitive and specific, it could be used for earlier and more accurate identification of students with emotional and behavioural difficulties. A mixed effects model will be used assess the effect of the intervention. Given this study is a pilot, both linear and logistic regression modelling will be used to assess which method is the most appropriate for a larger study. Analysis will be completed using Stata 16.0.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
31/05/2021
Actual
11/06/2021
Date of last participant enrolment
Anticipated
20/06/2021
Actual
22/08/2021
Date of last data collection
Anticipated
1/03/2022
Actual
Sample size
Target
720
Accrual to date
Final
401
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 307597 0
Government body
Name [1] 307597 0
NHMRC postgraduate scholarship for University of Melbourne/Murdoch Children's Research Institute
Country [1] 307597 0
Australia
Primary sponsor type
Government body
Name
Murdoch Children's Research Institute
Address
Royal Children's Hospital, 50 Flemington Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 308290 0
University
Name [1] 308290 0
University of Melbourne
Address [1] 308290 0
Parkville VIC 3010
Country [1] 308290 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307652 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 307652 0
Ethics committee country [1] 307652 0
Australia
Date submitted for ethics approval [1] 307652 0
15/01/2021
Approval date [1] 307652 0
16/03/2021
Ethics approval number [1] 307652 0
HREC/67653/RCHM-2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108014 0
Dr William Garvey
Address 108014 0
The Royal Children's Hospital
50 Flemington Road
Parkville, Victoria 3052
Country 108014 0
Australia
Phone 108014 0
+61 409 358 496
Fax 108014 0
Email 108014 0
[email protected]
Contact person for public queries
Name 108015 0
William Garvey
Address 108015 0
The Royal Children's Hospital
50 Flemington Road
Parkville, Victoria 3052
Country 108015 0
Australia
Phone 108015 0
+61 409 358 496
Fax 108015 0
Email 108015 0
[email protected]
Contact person for scientific queries
Name 108016 0
William Garvey
Address 108016 0
The Royal Children's Hospital
50 Flemington Road
Parkville, Victoria 3052
Country 108016 0
Australia
Phone 108016 0
+61 409 358 496
Fax 108016 0
Email 108016 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
case-by-case basis at the discretion of Primary Sponsor
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA health-education intervention to improve outcomes for children with emotional and behavioural difficulties: Protocol for a pilot cluster randomised controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-060440
N.B. These documents automatically identified may not have been verified by the study sponsor.