Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001447842p
Ethics application status
Submitted, not yet approved
Date submitted
14/09/2021
Date registered
25/10/2021
Date last updated
25/10/2021
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Telehealth Programme for the Treatment of Toileting Problems in Children on the Autism Spectrum
Scientific title
An investigation into the effectiveness of telehealth-delivered interventions for toileting problems in children on the autism spectrum
Secondary ID [1] 305293 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
U1111-1269-4283

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 323597 0
Toilet training difficulties 323598 0
Condition category
Condition code
Mental Health 321141 321141 0 0
Autistic spectrum disorders
Neurological 321142 321142 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Phases:

Phase 1: Assessment. A clinical interview will be undertaken via videoconferencing to ascertain the safety and suitability of the programme for each participant, and to gather information about the child’s developmental history; family context; toileting problems; and demographic information. This interview will last between 30-45 minutes in duration and will be undertaken by a registered psychologist or post-graduate student who is a member of the research team, under the supervision of the lead investigator.

Phase 2: Baseline. Parents will be randomly assigned to a baseline length of 5, 10, or 15 days. Parent-reported diary data will be collected on the frequency and duration of toileting sits and the frequency of successful in-toilet/potty voiding and accidents (i.e., voiding off the toilet or potty).

Phase 3: Intervention. Intervention will consist of two sequential sub-phases. Progression through each sub-phase will depend on whether the identified problem has resolved and/or parents’ satisfaction with progress.

Intervention sub-phase 1 - parent psychoeducation and online learning modules. Parents will independently engage with web-based, multi-media content, activities, and resources, embedded within a series of modules. Module content will be developed based on existing empirical research and the extensive research and clinical expertise of the named investigators, and empirically-supported interventions for toileting difficulties. Collectively, these modules will form an online parent Toolkit relating to each health-promoting behaviour. It is estimated that it will take parents 1-2 hours to work through each module and they will engage with these modules at their own discretion. This phase will last for four weeks.

For parents in the toileting study, Module 1 will provide foundational knowledge regarding central aspects of toilet training, including why toilet training is important and why autism might make toilet training more difficult. Module 2 provide information about preparation for toilet training, including equipment, ways to adapt the toilet area, and how to increase your child’s readiness for training. Module 3 provides strategies and resources such as visual supports that help children with autism to learn new toileting skills and behaviours. Module 4 and Module 5 focus on toilet training procedures, including options for a more gradual or a more intensive approach. Module 6 will cover additional information such as managing setbacks and other problems. Taken together, these modules will provide parents with key information, strategies, and resources to help your child improve their toileting behaviour.

Intervention sub-phase 2 - synchronous videoconferencing in small groups (n = 3-5 families/group) with weekly feedback from a specialist. This phase will commence immediately after intervention sub-phase 1. During this phase, parents will partake in small group, weekly, 2-hour video conferencing sessions where they will have the opportunity to pose questions and discuss treatment plans with a specialist (e.g., named investigator or psychologist). The specialist will use assessment information to support parents to select empirically supported interventions and progress will be reviewed weekly within group training sessions. This phase will last for 4 weeks.

Intervention sub-phase 3 – synchronous, individualized, parent coaching sessions. Parent coaching will be provided for individual parents during the toileting routine. This live coaching will be provided weekly, for up to one hour, by a specialist who is a member of the research team, for a period of four weeks. Parents will be supported to implement interventions during this time (e.g., use of visual supports, social stories, and/or rewards). This phase will commence immediately following completion of intervention sub-phase 2.

Phase 4: Follow-up. Data will be collected for one week, at 12 weeks and 6 months post-intervention, to assess the maintenance of intervention effects.

Parents will be asked to record the strategies that they implemented during intervention within the data sheets. Website analytics will be used to assess the frequency and duration of engagement with web-based materials. Attendance at weekly group coaching sessions and individualized coaching will be recorded by the research team.

It should be noted that participants can choose to withdraw from intervention at any time. If they are satisfied with their child’s progress and do not wish to proceed to intervention sub-phase 2 or 3 then they do not have to do so. If a parent would like to remain in intervention sub-phase 1 for more than four weeks they will not be able to progress to intervention sub-phase 2, as this is a group coaching phase and relies upon a cohort progressing collectively. If this is the case, parents can continue to have independent site access but will be considered to have withdrawn from the study. There is no ‘readiness’ criteria for progressing through intervention phases that is stipulated by the research team as the levels of support increase across each phase. On conclusion of the 12-week intervention period (the maximum duration of involvement in the study), parents can continue to have independent access to the website, if they choose to do so though they will not be required to collect data beyond the 12 weeks.
Intervention code [1] 321697 0
Behaviour
Intervention code [2] 321698 0
Treatment: Other
Comparator / control treatment
No control group. This study will use a single-case multiple baseline design, wherein each participant will act as their own control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328944 0
Toileting behaviour will be assessed using a parent-recorded diary specifically designed for this study.
Timepoint [1] 328944 0
Diaries will be collected daily over a period of 5, 10, or 15 days at baseline (depending on randomly assigned baseline length), throughout treatment (daily for 12 weeks; primary timepoint) and for one week during short.- and long-term follow-up; 3 months and 6 months post-intervention completion, respectively.
Primary outcome [2] 328948 0
Profile of Toileting Issues will be completed to provide an assessment of general toileting behaviours.
Timepoint [2] 328948 0
Administered once during baseline, once immediately upon conclusion of treatment, and once at short-term follow-up (3 months post-treatment).
Secondary outcome [1] 400910 0
Cultural acceptability will be assessed during 30-minute, semi-structured, interviews with Maori parents.
Timepoint [1] 400910 0
These interviews will be undertaken immediately on conclusion of treatment (12 weeks following intervention commencement). .
Secondary outcome [2] 400925 0
Children's daytime behaviour: - Parents will complete the Child Behavior Checklist [Achenback & Rescorla, 2000] to assess change in children’s daytime behaviour following treatment.
Timepoint [2] 400925 0
Administered once during baseline, once immediately upon conclusion of treatment (12 weeks post-intervention commencement) and once at short-term follow-up (3 months post-treatment).
Secondary outcome [3] 400931 0
Parent wellbeing: Parents will complete the Depression, Anxiety, and Stress Scale (Lovibond, 1995) to assess change in their mental health, following treatment.
Timepoint [3] 400931 0
Administered once during baseline, once immediately upon conclusion of treatment (12 weeks post-intervention commencement) and once at short-term follow-up (3 months post-treatment).
Secondary outcome [4] 400932 0
Parent acceptability: A semi-structured post-treatment interview of approximately 30-minutes in duration, will measure parent perceptions of the acceptability of telehealth technology and the quality of the assessment and intervention.
Timepoint [4] 400932 0
The post-treatment interview will be undertaken immediately upon conclusion of treatment (12 weeks post-intervention commencement)
Secondary outcome [5] 400933 0
Website access will be examined to determine the frequency and duration of parental engagement with website content.
Timepoint [5] 400933 0
Website analytics will be examined immediately upon conclusion of treatment (12 weeks post-intervention commencement)
Secondary outcome [6] 400934 0
Study retention - The research team will keep records of how many participants progress through each study phase to calculate attrition rates.
Timepoint [6] 400934 0
This data will be collected at study completion (12 weeks post-intervention commencement).
Secondary outcome [7] 400935 0
Children's daytime behaviour: - Parents will complete the Gilliam Autism Rating Scale [Gilliam, 2005] to assess change in children’s daytime behaviour following treatment.
Timepoint [7] 400935 0
Administered once during baseline, once immediately upon conclusion of treatment (12 weeks post-intervention commencement) and once at short-term follow-up (3 months post-treatment).
Secondary outcome [8] 400936 0
Children's daytime behaviour: - Parents will complete the Pediatric Quality of Life Inventory [Varni, 2017] to assess change in children’s daytime behaviour following treatment.
Timepoint [8] 400936 0
Administered once during baseline, once immediately upon conclusion of treatment (12 weeks post-intervention commencement) and once at short-term follow-up (3 months post-treatment).
Secondary outcome [9] 400937 0
Children's daytime behaviour: - Parents will complete the Vineland Adaptive Behavior Scales-III [Sparrow, Cicchetti, & Saulnier, 2016] to assess change in children’s daytime behaviour following treatment.
Timepoint [9] 400937 0
Administered once during baseline, once immediately upon conclusion of treatment (12 weeks post-intervention commencement) and once at short-term follow-up (3 months post-treatment).
Secondary outcome [10] 400938 0
Parent wellbeing: Parents will complete the Relationship Quality Index (RQI) [Norton, 1983] to assess change in parental relationship quality following treatment.
Timepoint [10] 400938 0
Administered once during baseline, once immediately upon conclusion of treatment (12 weeks post-intervention commencement) and once at short-term follow-up (3 months post-treatment).
Secondary outcome [11] 400939 0
Parent acceptability: The Treatment Acceptability Rating Form [Reimers & Wacker, 1988] will measure parent perceptions of the acceptability of telehealth technology and the quality of the assessment and intervention.
Timepoint [11] 400939 0
This measure will be administered immediately upon conclusion of treatment (12 weeks post-intervention commencement).

Eligibility
Key inclusion criteria
Participantswill include a minimum of 15 parent-child dyads who meet the following inclusion criteria: (1) a formal diagnosis of Autism Spectrum Disorder (ASD) or features of ASD (i.e., awaiting diagnosis); (2) between 2 and 5 years of age; (3) parent-reported toileting problems; (4) absence of a physical/medical condition affecting that may make implementation of a behavioural intervention unsafe and are not being effectively managed; and (5) not currently receiving services in the target domain.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children will be excluded from the study if they are currently under the care of a paediatrician, gastroenterologist, or other specialist with respect to toileting as these children are likely to have co-occurring medical conditions or difficulties that require a more comprehensive intervention. If in doubt, we will consult with the specialist providing this medical care, to determine the safety and suitability of the programme.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Non-concurrent multiple baseline.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A minimum sample size of n=15 child-parent dyads will ensure sufficient replications to support causal inferences about treatment effects and will permit group statistical as well as individual analysis.

Data will be reported from all cases following the intention-to-treat principle, with description of means, medians, and ranges for each phase. Time-series diary data will be graphed using standard multiple-baseline graphs and examined for changes in level, trend, and variability across phases and participants and for any pattern of therapeutic change coincident with therapy phases. Magnitude of therapy effect will be assessed by the Percent Deviating from the Median (PDM) Effect Size (ES). DVs for which there is one or a few data points per case per phase (e.g., VABS-III; DASS) will be analysed by Modified Brinley Plots, Cohen’s d (standardised mean difference) ES with 95%Confidence Intervals and the Common Language ES (CLES). Website analytics data (e.g., engagement) will be used to examine any moderation effects on treatment outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
1/11/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 24117 0
New Zealand
State/province [1] 24117 0

Funding & Sponsors
Funding source category [1] 309664 0
Government body
Name [1] 309664 0
Lotteries Health
Country [1] 309664 0
New Zealand
Primary sponsor type
Individual
Name
A/Prof. Laurie McLay
Address
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 310683 0
University
Name [1] 310683 0
University of Canterbury
Address [1] 310683 0
Private bag 4800
Christchurch 8140
Country [1] 310683 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309432 0
Northern Health and Disability Ethics Committee
Ethics committee address [1] 309432 0
Ethics committee country [1] 309432 0
New Zealand
Date submitted for ethics approval [1] 309432 0
12/08/2021
Approval date [1] 309432 0
Ethics approval number [1] 309432 0

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

Contacts
Principal investigator
Name 114142 0
A/Prof Laurie McLay
Address 114142 0
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch 8140
Country 114142 0
New Zealand
Phone 114142 0
+64 03 369 3522
Fax 114142 0
Email 114142 0
[email protected]
Contact person for public queries
Name 114143 0
Laurie McLay
Address 114143 0
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch 8140
Country 114143 0
New Zealand
Phone 114143 0
+64 03 369 3522
Fax 114143 0
Email 114143 0
[email protected]
Contact person for scientific queries
Name 114144 0
Laurie McLay
Address 114144 0
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch 8140
Country 114144 0
New Zealand
Phone 114144 0
+64 03 369 3522
Fax 114144 0
Email 114144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.