Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001424897p
Ethics application status
Submitted, not yet approved
Date submitted
24/08/2021
Date registered
21/10/2021
Date last updated
21/10/2021
Date data sharing statement initially provided
21/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Telehealth Programme for the Treatment of Eating/Feeding Problems in Children on the Autism Spectrum
Scientific title
An investigation into the effectiveness of telehealth-delivered interventions for eating/feeding problems in children on the autism spectrum
Secondary ID [1] 305035 0
None
Universal Trial Number (UTN)
U1111-1267-0856
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 323206 0
Parent-reported eating/feeding problems. 323207 0
Condition category
Condition code
Mental Health 320790 320790 0 0
Autistic spectrum disorders
Neurological 320791 320791 0 0
Other neurological disorders
Diet and Nutrition 321140 321140 0 0
Other diet and nutrition 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; eating/feeding 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 type and quantity of foods consumed and the frequency, severity, and duration of each any challenging behaviour associated with eating/feeding across this baseline period.

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 feeding 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 feeding study, Module 1 will focus on identification and assessment of feeding problems, and goal setting. Module 2 will focus on the role of nutrition and appetite and its overall impact on feeding difficulties (e.g., mealtime routine, meal schedule, and meal duration). Strategies to assist in the mealtime routine will also be introduced. Module 3 will help parents to identify the events that occur before or during mealtime that affect your children’s eating and strategies that can be implemented ahead of time that might make the mealtime more positive and help children to become competent eaters. Module 4 will focus on the identification of consequences that affect children’s eating, such as rewards for positive behaviour and will include strategies that can be used in response to children eating or not eating. Module 5 will help parents to summarize the information they learned and come up with a plan to help improve children’s feeding.

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 mealtime 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. 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] 321429 0
Behaviour
Intervention code [2] 321699 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] 328605 0
Eating/feeding behaviour will be assessed using a parent-recorded diary specifically designed for this study.
Timepoint [1] 328605 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) and for one week during short.- and long-term follow-up; 3 months and 6 months post-intervention completion, respectively.
Primary outcome [2] 328946 0
Brief Autism Mealtime Behaviour Inventory - a measure of children's mealtime behaviour.
Timepoint [2] 328946 0
Administered once during baseline, once immediately upon conclusion of treatment, and once at short-term follow-up (3 months post-treatment).
Primary outcome [3] 328947 0
Photographs of children's dinner plates will be provided before and after mealtime to assess the amount of food that has been consumed.
Timepoint [3] 328947 0
Photographs of children's dinner plates will be provided daily for five days during baseline, the final five days of intervention sub-phases 1, 2, and 3, and for five days during short- and long-term follow-up.
Secondary outcome [1] 399624 0
Cultural acceptability will be assessed during 30-minute, semi-structured, interviews with Maori participants.
Timepoint [1] 399624 0
These interviews will be undertaken immediately on conclusion of treatment (12 weeks following intervention commencement). .
Secondary outcome [2] 399625 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] 399625 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] 400039 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] 400039 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] 400040 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] 400040 0
The post-treatment interview will be undertaken immediately upon conclusion of treatment (12 weeks post-intervention commencement)
Secondary outcome [5] 400041 0
Website access will be examined to determine the frequency and duration of parental engagement with website content.
Timepoint [5] 400041 0
Website analytics will be examined immediately upon conclusion of treatment (12 weeks post-intervention commencement)
Secondary outcome [6] 400042 0
Study retention - The research team will keep records of how many participants progress through each study phase to calculate attrition rates.
Timepoint [6] 400042 0
This data will be collected at study completion (12 weeks post-intervention commencement).
Secondary outcome [7] 400926 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] 400926 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] 400927 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] 400927 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] 400928 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] 400928 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] 400929 0
Parent wellbeing: Parents will complete the Relationship Quality Index (RQI) [Norton, 1983] to assess change in parental relationship quality following treatment.
Timepoint [10] 400929 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] 400930 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] 400930 0
This measure will be administered immediately upon conclusion of treatment (12 weeks post-intervention commencement).

Eligibility
Key inclusion criteria
Participants will 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 eating/feeding 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 or dietician with respect to eating/feeding as these children are likely to have nutritional concerns or feeding difficulties that require a more comprehensive intervention (e.g., presence of a feeding tube, prescription for specialised formula). 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
1/12/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 24039 0
New Zealand
State/province [1] 24039 0

Funding & Sponsors
Funding source category [1] 309424 0
Government body
Name [1] 309424 0
Lotteries Health
Country [1] 309424 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor Laurie McLay
Address
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 310395 0
University
Name [1] 310395 0
University of Canterbury
Address [1] 310395 0
Private bag 4800
Christchurch 8140
Country [1] 310395 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309226 0
Northern Health and Disability Ethics Committee
Ethics committee address [1] 309226 0
Ethics committee country [1] 309226 0
New Zealand
Date submitted for ethics approval [1] 309226 0
12/08/2021
Approval date [1] 309226 0
Ethics approval number [1] 309226 0

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

Contacts
Principal investigator
Name 113410 0
A/Prof Laurie McLay
Address 113410 0
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch 8140
Country 113410 0
New Zealand
Phone 113410 0
+64 03 369 3522
Fax 113410 0
Email 113410 0
[email protected]
Contact person for public queries
Name 113411 0
Laurie McLay
Address 113411 0
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch 8140
Country 113411 0
New Zealand
Phone 113411 0
+64 03 369 3522
Fax 113411 0
Email 113411 0
[email protected]
Contact person for scientific queries
Name 113412 0
Laurie McLay
Address 113412 0
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch 8140
Country 113412 0
New Zealand
Phone 113412 0
+64 03 369 3522
Fax 113412 0
Email 113412 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.