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Telehealth-delivered sleep treatment for children with Autism Spectrum Disorder

Sleep Well, Live Well: A Telehealth Programme for the Treatment of Sleep Problems in Children with Autism Spectrum Disorder

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001074886
Enrollment
5
Registered
2021-08-16
Start date
2021-07-30
Completion date
2023-12-01
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The number of diagnosed cases of autism has markedly increased in recent years. Therefore, demand for services often exceeds availability. Within Aotearoa, support for children with ASD and their families is typically delivered in a face-to-face meeting with a specialists. Moreover, evidence-based behavioural treatments, although effective, are often expensive, time consuming, and require many resources. In many cases, this prevents access to services for those in remote, underserved or impoverished communities. One potential solution is to use a telehealth approach. Sleep is an area where there is a significant shortage of specialist support. Since the problem occurs at night, and the parents deliver the solution, telehealth offers an ideal model for service delivery. However, a systematic review by the research team (McLay, Sutherland, Machalicek, & Sigafoos, 2020) failed to identify any studies using this approach for the treatment of sleep problems in children with ASD. This study has four aims: 1. To explore the efficacy of telehealth-delivered behavioural treatment methods for sleep problems in children with ASD. 2. To identify the essential components of effective telehealth interventions for addressing sleep problems in children with ASD. 3. To identify whether the telehealth approach is seen by caregivers to be culturally responsive, acceptable, and beneficial to themselves and their child. 4. To assess the impact of the sleep treatment programme on the children’s daytime behaviour and symptoms of ASD, and parent and child wellbeing. We hypothesise that: 1. Behavioural interventions for the treatment of sleep problems, delivered via telehealth, will result in a reduction in sleep problems 2. Reduction in sleep problems will be maintained at follow-ups 3. The telehealth technologies will support parents to implement interventions with fidelity 4. The resolution of sleep problems will result in improvements in children’s daytime behaviour, ASD symptomology, and parent and child wellbeing. We aim to recruit 30 parent-child dyads who meet the following criteria: (1) a diagnosis of ASD; (2) between 2 and 18 years of age; (3) parent-reported sleep problems (e.g., trouble falling asleep, night wakings); and (4) no medical condition or medication use that may interfere with behavioural treatments.

Interventions

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 pha

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.

Sponsors

Associate Professor Laurie McLay
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years
Healthy volunteers
Yes

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).

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026