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A Randomized Controlled Trial to Evaluate the Effect of Tailored Behavioral Sleep Interventions for Non-Respiratory Sleep Disorders in Children with Neurodisability Compared to Routine Care

A Randomized Controlled Trial to Evaluate the Effect of Tailored Behavioral Sleep Interventions for Non-Respiratory Sleep Disorders in Children with Neurodisability Compared to Routine Care

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000736549
Enrollment
150
Registered
2024-06-14
Start date
2024-08-01
Completion date
2025-07-31
Last updated
2024-06-24

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 primary purpose of this study to evaluate the effectiveness of behavioural sleep interventions for treatment of non-respiratory sleep disorders in children with ND. Alongside this, we hope to determine the optimal mode of delivery of treatment for non-respiratory sleep disorders in children with ND. Therefore, we developed the following two hypothesis: (i) A structured behavioural sleep intervention program will be more effective than standard clinical treatment for the management of non-respiratory sleep problems in children with ND. and (ii) Group telehealth and app delivery of a behavioural sleep intervention program will be as effective as standard clinical care for the management of non-respiratory sleep problems in children with ND.

Interventions

Participants will be randomised into one of two active intervention groups.: 1) Receive Intervention A- individual eADVICE-online sleep program accessed by parent as many times as they wish (IxA). 2) Receive Intervention B- parent group telehealth delivered by a psychologist or specialist sleep nurse trained in delivery of sleep interventions (IxB). Intervention group A will be an individualised program for the child accessed by the parent using an electronic device, The interventions will be

Participants will be randomised into one of two active intervention groups.: 1) Receive Intervention A- individual eADVICE-online sleep program accessed by parent as many times as they wish (IxA). 2) Receive Intervention B- parent group telehealth delivered by a psychologist or specialist sleep nurse trained in delivery of sleep interventions (IxB). Intervention group A will be an individualised program for the child accessed by the parent using an electronic device, The interventions will be structured by the initial answers given by parents when completing questions in the introductory part of the program, about their child’s sleep. Answers will lead to a decision tree for treatment advice, based on the problems described. The decision tree will include generic advice regarding sleep hygiene and routines and then lead on to specific treatments for specific sleep problems, funnelling participants to the correct advice according to their responses. For example if a participant reports sensory processing concerns advice will be directed to a module regarding management of sensory issues relating to sleep. Modules will include: psychoeducation around sleep, bedtime routines, special consideration at bedtime relating to diagnosis (example visual impairment and bedtime), how we change behaviour, specific sleep strategies directly treating a sleep issue (for example: camping out method for a sleep association). Age modules of preschool, school aged and high school aged show adapted content and examples to suit the age. Participants can choose to receive treatment advice in a printable text format or from an online character (“Dr Sam”) that interacts with them. Printable text will be dependant on how much advice is required, however generally would be 2-3 page handouts. The online interaction will be provided by short 5-10 minute interactions with "Dr Sam" for each strategy/advice. Parents can revisit the program to input additional information, resulting in modification of subsequent treatment advice. Families will be self-directed in their access to the online program, with up to them how often they access it. The families can access the program at any time through the 12-month study, with frequency of access the program logged. Intervention group B is a parent-based group behavioural intervention based on an intervention found to be effective in children with Attention Deficit and Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD), an important subgroup of the neurodisability (ND) population. For this study the program will be adapted to suit a wider spectrum of ND groups. The intervention will involve two group telehealth sessions (2 hours in duration) conducted 7 days apart. Each group session will involve the Educator (trained professional-sleep clinical nurse or psychologist) and 2-4 parents. Session content will include modules on sleep hygiene, sleep amount/timing/regularity, bedtime routine and finally strategies to minimise bedtime resistance, night wakings and co-sleeping (i.e., graduated extinction, bedtime pass, social story). Homework will involve datasheets to complete each night, including elements discussed in the sessions taking approximately 15-30 minutes to complete. Two follow-up phone calls 2 weeks apart with the educators and each parent will occur to check compliance and completion of homework tasks.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
2 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Children who are new patients to the sleep clinic, with a clinician diagnosed ND aged 2-18 years old, and a non-respiratory sleep issue that has been confirmed by a tertiary sleep specialist and requires treatment. Children and caregivers will be required to speak English to a required level to undertake the intervention. Parents with a child that meets inclusion will be invited to participate.

Exclusion criteria

Children without a clinician diagnosed ND, under 2 years old or over 18 years old, or without diagnosed sleep issues.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026