Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001074886
Ethics application status
Approved
Date submitted
28/06/2021
Date registered
16/08/2021
Date last updated
18/07/2022
Date data sharing statement initially provided
16/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Telehealth-delivered sleep treatment for children with Autism Spectrum Disorder
Scientific title
Sleep Well, Live Well: A Telehealth Programme for the Treatment of Sleep Problems in
Children with Autism Spectrum Disorder
Secondary ID [1] 304604 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 322530 0
Parent-reported sleep problems (e.g., sleep onset delay, frequent and prolonged night wakings, unwanted co-sleeping). 322531 0
Condition category
Condition code
Mental Health 320160 320160 0 0
Autistic spectrum disorders
Neurological 320467 320467 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Phases
Phase 1: Assessment. A clinical interview (approximately 30-45 minutes in duration) 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, sleep problem/s, and demographic information. This reflects an adapted version of the standard format and questions for clinical interviews conducted within the Pukemanu Centre Clinic. During this phase parents will also complete the Sleep Assessment Treatment Tool (SATT; Hanley, 2005). 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. Data will be collected on children’s baseline sleep patterns via parent completion of online sleep diaries and actigraphy.

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

Intervention sub-phase 1 - parent psychoeducation and online learning modules. Parents will engage with web-based, multi-media content, activities, and resources, embedded within a series of modules. Module content will be adapted from the parent-based sleep education manual created by Malow et al. [2013] and the extensive research and clinical expertise of the named investigators [McLay et al., 2017; McLay et al., 2019; McLay et al., 2020]. Collectively, these modules will form an online parent toolkit. Module 1 will support parents in the assessment and identification of specific sleep problems, including identification of circadian factors (i.e., 24-hour sleep/wake schedules), environmental variables and contingencies of reinforcement that may precipitate or maintain sleep problems. Module 2 will support parents to identify and modify basic sleep hygiene practices (e.g., ensuring a consistent bedtime and sleep conducive environment). Module 3 will focus on the modification of contingencies maintaining sleep problems (e.g., graduated extinction and use of rewards), and Module 4 will focus on teaching children skills that support their sleep. Module 5 will focus on the use of information from modules 1-4, to develop an individualized and comprehensive treatment plan. Content relating to treatment practices describes those that are empirically supported for use with children with ASD [McLay et al., 2017; McLay et al., 2019; McLay et al., 2020; Turner & Johnson, 2013]. It is anticipated that parents will spend 1-2 hours per week engaging with online modules. As some whanau may not have digital devices, the website will be mobile-optimised.

Intervention sub-phase 2 - synchronous videoconferencing in small groups (n = 4 families/group) with weekly feedback from a sleep specialist. 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 sleep specialist (e.g., PI or psychologist). The sleep 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 four weeks.

Intervention sub-phase 3 – synchronous, individualized, parent coaching sessions. Parent coaching will be provided for individual parents during the bedtime routine and initial sleep onset period. This live coaching will be provided for approximately one hour/week by a sleep specialist, for a period of four weeks. Parents will be supported to implement interventions during this time (e.g., use of reinforcement, use of visual supports and social stories, support in coaching children through the bedtime routine).
Phase 4: Follow-up. Data will be collected for one week, 12 weeks and 6 months post-intervention, respectively to assess the maintenance of intervention effects.

Parents will be asked to record the strategies that they implemented during intervention within the sleep diaries. 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] 320963 0
Behaviour
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] 328042 0
Child sleep measures: Parent-reported daily sleep diaries will record the primary dependent variables of frequency and duration of sleep problems (e.g., night wakings – NWs, sleep onset delay - SOD) and total sleep time (TST) and will also allow the researchers to determine the strategies that parents implemented. Actigraphs will provide an objective measure of dependent sleep variables. The Children’s Sleep Habits Questionnaire (CSHQ) [Owens et al., 2000] will assess overall change in sleep problem type and severity.
Timepoint [1] 328042 0
Sleep diaries will be collected daily throughout the assessment, intervention, and follow up phases.

Actigraph data will be collected during the final week of baseline, intervention, and follow up phases.

CSHQ will be administered during baseline, post-intervention, and at follow-ups.
Secondary outcome [1] 397318 0
Children's daytime behaviour: - Parents will complete the Child Behavior Checklist [Achenback & Rescorla, 2000], Gilliam Autism Rating Scale [Gilliam, 2005], the Pediatric Quality of Life Inventory [Varni, 2017], and the Vineland Adaptive Behavior Scales-III [Sparrow, Cicchetti, & Saulnier, 2016] to assess change in children’s daytime behaviour following treatment.
Timepoint [1] 397318 0
These secondary measures will be administered during baseline, post-intervention, and at follow-ups
Secondary outcome [2] 397319 0
Parent wellbeing: Changes in parent mental health, sleep quality, and relationship quality will be measured using the Depression, Anxiety, and Stress Scale (Lovibond, 1995), Relationship Quality Index (RQI) [Norton, 1983], and Pittsburgh Sleep Quality Index (PSQI) [Buysse et al., 1989].
Timepoint [2] 397319 0
These secondary parent measures will be administered during baseline, post-intervention, and at follow-ups
Secondary outcome [3] 397320 0
Interobserver agreement data (IOA) will be collected by comparing actigraphy data with sleep diaries to determine the accuracy of sleep diary data.
Timepoint [3] 397320 0
IOA will be calculated for approximately 30% of nights throughout study phases.
Secondary outcome [4] 397321 0
Parent acceptability: A semi-structured post-treatment interview, and 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 [4] 397321 0
Parent ratings of the acceptability of intervention will be assessed post treatment
Secondary outcome [5] 397322 0
Website access will be examined to determine the frequency and duration of parental engagement with website content.
Timepoint [5] 397322 0
Website analytics will be examined throughout intervention and follow-up phases
Secondary outcome [6] 398480 0
Study retention
Timepoint [6] 398480 0
The research team will keep records of how many participants progress through each study phase to calculate attrition rates.

Eligibility
Key inclusion criteria
We aim to recruit up to 30 participants who meet the following inclusion criteria: (1) a diagnosis of autism spectrum disorder; (2) between 2 and 18 years of age; (3) parent-reported sleep problems (e.g., sleep onset delay, night wakings); and (4) absence of a medical condition or medication use that may be a contra-indicator for behavioural intervention. Participants will be excluded from this study if they have a co-occurring medical condition that may interfere with their sleep (e.g., obstructive sleep apnea; nocturnal seizure disorder, gastrointestinal problems) that are not effectively managed or are taking medications that may interfere with sleep (e.g., some stimulant medications). This will be determined in consultation with the child’s medical doctor (e.g., GP or paediatrician). The research team has established channels for referrals based upon her current research programmes (e.g., The Good Nights Programme).
Minimum age
2 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from this study if they have a co-occurring medical condition that may interfere with their sleep (e.g., obstructive sleep apnea; nocturnal seizure disorder, gastrointestinal problems) that is not effectively managed or are taking medications that may interfere with sleep (e.g., some stimulant medications).

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=30 child-parent dyads will ensure sufficient replications to support causal inferences about treatment effects and will permit group statistical as well as individual analysis.

Time-series diary data will be graphed using standard multiple-baseline graphs and examined for changes across phases and participants in level, trend, and variability and for any pattern of therapeutic change coincident with therapy phases. We will report effect sizes using non-overlap of all pairs (NAP) and will calculate a within-case standardized mean difference analysis, Hedges’ g [Hedges, 1981, Hedges, 2013]. Hedges’ g is an effect size calculated similarly to a standard Cohen’s d effect size (0.2 = small, 0.5 = medium, 0.8 = large), wherein control means are subtracted from treatment means and divided by standard error. Hedges’ g allows for the small sample size in this study and takes into account the (a) number of cases, (b) number of measurements per case, (c) autocorrelation, and (d) intra-class correlation, measuring the ratio of between-case variance to the sum of between and within case variance.



Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/07/2021
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
30/04/2024
Actual
Sample size
Target
60
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 23847 0
New Zealand
State/province [1] 23847 0
All of New Zealand

Funding & Sponsors
Funding source category [1] 308966 0
Government body
Name [1] 308966 0
Lotteries Health
Country [1] 308966 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
NZ
Country
New Zealand
Secondary sponsor category [1] 309936 0
University
Name [1] 309936 0
University of Canterbury
Address [1] 309936 0
Private bag 4800
Christchurch 8140
New Zealand
Country [1] 309936 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308854 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 308854 0
Ethics committee country [1] 308854 0
New Zealand
Date submitted for ethics approval [1] 308854 0
Approval date [1] 308854 0
23/06/2021
Ethics approval number [1] 308854 0
21CEN80

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

Contacts
Principal investigator
Name 112126 0
A/Prof Laurie McLay
Address 112126 0
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch
8140
New Zealand
Country 112126 0
New Zealand
Phone 112126 0
+64 03 369 3522
Fax 112126 0
Email 112126 0
[email protected]
Contact person for public queries
Name 112127 0
Laurie McLay
Address 112127 0
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch
8140
New Zealand
Country 112127 0
New Zealand
Phone 112127 0
+64 03 369 3522
Fax 112127 0
Email 112127 0
[email protected]
Contact person for scientific queries
Name 112128 0
Laurie McLay
Address 112128 0
School of Health Sciences
University of Canterbury
Private bag 4800
Christchurch
8140
New Zealand
Country 112128 0
New Zealand
Phone 112128 0
+64 03 369 3522
Fax 112128 0
Email 112128 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.