Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000736549
Ethics application status
Approved
Date submitted
30/03/2024
Date registered
14/06/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 311476 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neurodevelopmental conditions 332796 0
Sleep Problems 332797 0
Neurodisability 332798 0
Paediatric Sleep Issues 332799 0
Condition category
Condition code
Neurological 330249 330249 0 0
Other neurological disorders
Mental Health 330250 330250 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 330251 330251 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327930 0
Behaviour
Comparator / control treatment
standard clinical advice
Within the standard clinical advice group, Sleep hygiene advice will be provided to all new patients attending the sleep clinic, including those referred for sleep disordered breathing (SDB). Clinicians will be asked to complete a brief form after the consultation, indicating if they have covered specific areas including (a) Sleep hygiene, (b) Sleep amount/timing/regularity, (c) Bedtime routine and (d) Specific sleep strategies e.g., extinction, graduated extinction, bedtime passes, stimulus control procedures, positive reinforcement, relaxation techniques, social stories, imaginations.
Control group
Active

Outcomes
Primary outcome [1] 337313 0
Change in Sleep Total Score on Child Sleep Habits Questionnaire from baseline to 6 months and 12 months
Timepoint [1] 337313 0
baseline, 6 months (primary timepoint), 12 months post initiation of intervention
Secondary outcome [1] 431414 0
Change in CHSQ Sleep Subscales (Sleep latency and insomnia)
Timepoint [1] 431414 0
6 months and 12 months post initiation of intervention
Secondary outcome [2] 433431 0
Change in the Child participant's behaviour and function
Timepoint [2] 433431 0
6 months and 12 months post initiation of intervention
Secondary outcome [3] 433432 0
Change in self-reported sleep quality
Timepoint [3] 433432 0
6 months and 12 months post initiation of intervention
Secondary outcome [4] 433433 0
Change in Quality of life scores
Timepoint [4] 433433 0
6 months and 12 months post initiation of intervention
Secondary outcome [5] 433434 0
Change in parental mental health scores
Timepoint [5] 433434 0
6 months and 12 months post initiation of intervention
Secondary outcome [6] 433435 0
Change in functional ability and behaviour of child participant
Timepoint [6] 433435 0
6 months and 12 months post initiation of intervention
Secondary outcome [7] 433436 0
Family feedback on acceptability of the mode of delivery of program
Timepoint [7] 433436 0
6 months and 12 months post initiation of intervention

Eligibility
Key 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.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be undertaken with a pre-generated random number sequence generated by the trial statistician using block randomisation. The randomisation list will be generated using the R statistical software and imported into REDCap. Randomisation will be stratified according to the developmental age group of children (3-5yr, 6-12yr, 13-16yr- assessed by developmental paediatrician) and by site (3 sites). Allocation to the control arm and two intervention arms will occur at a 1:1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 26151 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 26152 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 26153 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 42012 0
4101 - South Brisbane
Recruitment postcode(s) [2] 42013 0
3052 - Parkville
Recruitment postcode(s) [3] 42014 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 315762 0
Government body
Name [1] 315762 0
Australian Department of Health and Aged Care: Medical Research Future Fund (MRFF)
Country [1] 315762 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 317945 0
None
Name [1] 317945 0
Address [1] 317945 0
Country [1] 317945 0
Other collaborator category [1] 283075 0
Hospital
Name [1] 283075 0
Queensland Children's Hospital
Address [1] 283075 0
Country [1] 283075 0
Australia
Other collaborator category [2] 283078 0
Hospital
Name [2] 283078 0
Children's Hospital at Westmead
Address [2] 283078 0
Country [2] 283078 0
Australia
Other collaborator category [3] 283079 0
Hospital
Name [3] 283079 0
The Royal Children's Hospital Melbourne
Address [3] 283079 0
Country [3] 283079 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314623 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314623 0
Ethics committee country [1] 314623 0
Australia
Date submitted for ethics approval [1] 314623 0
13/01/2024
Approval date [1] 314623 0
21/02/2024
Ethics approval number [1] 314623 0
HREC/23/QCHQ/105383
Ethics committee name [2] 315017 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [2] 315017 0
Ethics committee country [2] 315017 0
Australia
Date submitted for ethics approval [2] 315017 0
02/04/2024
Approval date [2] 315017 0
Ethics approval number [2] 315017 0

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

Contacts
Principal investigator
Name 132198 0
A/Prof Jasneek Chawla
Address 132198 0
QLD Children's Hospital, 501 Stanley St, South Brisbane QLD 4101
Country 132198 0
Australia
Phone 132198 0
+61452662105
Fax 132198 0
Email 132198 0
[email protected]
Contact person for public queries
Name 132199 0
Kasey Fullwood
Address 132199 0
Centre for Children's Health Research, 62 Graham Street, South Brisbane QLD 4101
Country 132199 0
Australia
Phone 132199 0
+61 07 3069 7503
Fax 132199 0
Email 132199 0
[email protected]
Contact person for scientific queries
Name 132200 0
Kasey Fullwood
Address 132200 0
Centre for Children's Health Research, 62 Graham Street, South Brisbane QLD 4101
Country 132200 0
Australia
Phone 132200 0
+61 07 3069 7503
Fax 132200 0
Email 132200 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21580Study protocol  [email protected]
21581Informed consent form  [email protected]
22012Ethical approval  [email protected]



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.