Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001681842
Ethics application status
Approved
Date submitted
4/11/2021
Date registered
9/12/2021
Date last updated
17/11/2022
Date data sharing statement initially provided
9/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A brief behavioural sleep intervention for children with Attention Deficit/Hyperactivity Disorder: In-person or online?
Scientific title
Effectiveness of differing deliveries of a brief behavioural sleep intervention for children with Attention Deficit/Hyperactivity Disorder. A randomised controlled trial.
Secondary ID [1] 305696 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit/Hyperactivity Disorder 324170 0
Sleep Problems (Sleep-Wake Disorders) 324171 0
Condition category
Condition code
Mental Health 321643 321643 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Sleeping Sound intervention (Sciberras et al., 2010) consists of two 50-minute consultation sessions, two weeks apart, and a brief follow-up phone call for the child and their parent(s). This intervention has previously been evaluated in children with ADHD and sleep problems, in a face-to-face delivery (Hiscock et al., 2015; Sciberras et al., 2020). However, the present trial will examine intervention effectiveness based on mode of delivery, i.e., in-person vs. online (via Zoom). The intervention will be delivered by a provisional psychologist (clinical psychology or clinical neuropsychology), under the supervision of experienced clinical psychologists. The sessions will provide the children and their families with psychoeducation about appropriate sleep, and useful skills and techniques to establish to improve sleep challenges. The techniques provided will be tailored to the child's specific sleep challenges. Attendance and session duration will be monitored.

Materials will be provided to assist in information delivery. These include handouts about normal sleep, sleep cycles and sleep hygiene practices, and handouts for specific sleep challenges relevant to the child participant. The handouts were specifically designed for the Sleeping Sound programme. During the intervention sessions, the provisional psychologist will briefly discuss the handouts provided. The parents will be advised to review the handouts as much or as little as they feel is necessary.

Parents will also be provided with a sleep diary to complete from the first intervention session up to the follow-up phone call. They will be advised to bring this to the second intervention session and have it with them during the follow-up phone call.

References:
Hiscock, H., Sciberras, E., Mensah, F., Gerner, B., Efron, D., Khano, S., & Oberklaid, F. (2015). Impact of a behavioural sleep intervention on symptoms and sleep in children with attention deficit hyperactivity disorder, and parental mental health: Randomised controlled trial. BMJ, 350, h68.
Sciberras, E., Efron, D., Gerner, B., Davey, M., Mensah, F., Oberklaid, F., & Hiscock, H. (2010). Study protocol: The sleeping sound with attention-deficit/hyperactivity disorder project. BMC Pediatrics, 10(1), 1-9.
Sciberras, E., Mulraney, M., Mensah, F., Oberklaid, F., Efron, D., & Hiscock, H. (2020). Sustained impact of a sleep intervention and moderators of treatment outcome for children with ADHD: A randomised controlled trial. Psychological Medicine, 50(2), 210-219.
Intervention code [1] 322086 0
Behaviour
Intervention code [2] 322260 0
Treatment: Other
Comparator / control treatment
Online delivery. After providing consent and completion of baseline surveys, participants will be randomised by a member of the research team, not the primary investigator, to either the in-person or online delivery. The intervention will remain consistent between the two deliveries.
Control group
Active

Outcomes
Primary outcome [1] 329417 0
Child sleep assessed using the Childrens Sleep Habits Questionnaire, total score (parent report)
Timepoint [1] 329417 0
Baseline, 1 week post-intervention, 3 months post-intervention (primary timepoint)
Secondary outcome [1] 402525 0
Child sleep duration assessed by 7 night of actigraphy measured using the ActiGraph wGT3X-BT watch
Timepoint [1] 402525 0
Baseline, 1 week post-intervention, 3 months post-intervention
Secondary outcome [2] 402526 0
Child sleep onset latency assessed by 7 night of actigraphy measured using the ActiGraph wGT3X-BT watch
Timepoint [2] 402526 0
Baseline, 1 week post-intervention, 3 months post-intervention
Secondary outcome [3] 415938 0
Child sleep efficiency assessed by 7 nights of actigraphy measured using the ActiGraph wGT3X-BT watch
Timepoint [3] 415938 0
Baseline, 1 week post-intervention, 3 months post-intervention

Eligibility
Key inclusion criteria
- Children aged 5-12 years old with a confirmed ADHD diagnosis by a medical specialist
- Reported moderate/severe sleep problem by primary caregiver
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Families do not speak English
- Children with a diagnosed intellectual or other very severe cognitive disability
- Children with a confirmed active diagnosis of a medical sleep disorder, such as obstructive sleep apnoea or narcolepsy
- Children who are currently receiving sleep treatment elsewhere (except for natural sleep medication, for example, Melatonin)

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)
Participants will be randomised after provision of consent and completion of baseline surveys. Randomisation will be completed by a member of the research team (not the primary investigator) using a computerised sequence generator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule will be pre-generated using stratified block randomisation by a member of the research team (not the primary investigator). Randomisation will be stratified by age, gender and presence of comorbid disorder(s) to ensure similar proportions across groups. In the case of multiple child participants from the same family, each child will be randomised independently of one another.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Approximately 70 participants will take part in the study, allowing for appropriate power in statistical analysis. G*Power was utilised with a large treatment effect size (0.8) and an alpha value of 0.05.

Analyses will be run by ‘intention to treat’ at the level of the individual child. The scores at the pre-intervention time point will be compared to the one-week post-intervention scores and the three-month post-intervention scores to determine whether the sleep intervention improved the child's sleep, based on the treatment outcomes mentioned above.

A linear mixed modelling analysis will be completed to explore the potential variance between online and face-to-face deliveries of the sleep intervention, and a repeated measures analysis of variance will be used to assess potential improvements in sleep. Individual differences will be analysed via moderation analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/11/2021
Date of last participant enrolment
Anticipated
19/12/2022
Actual
Date of last data collection
Anticipated
20/03/2023
Actual
Sample size
Target
70
Accrual to date
78
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 310056 0
University
Name [1] 310056 0
University of Western Australia
Country [1] 310056 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway
Crawley, 6009
Western Australia
Country
Australia
Secondary sponsor category [1] 311107 0
None
Name [1] 311107 0
Address [1] 311107 0
Country [1] 311107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309749 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 309749 0
Ethics committee country [1] 309749 0
Australia
Date submitted for ethics approval [1] 309749 0
26/07/2021
Approval date [1] 309749 0
09/10/2021
Ethics approval number [1] 309749 0
2021/ET000637

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

Contacts
Principal investigator
Name 115258 0
Ms Maya Malkani
Address 115258 0
School of Psychological Science
University of Western Australia
35 Stirling Highway
Crawley, 6009
Western Australia
Country 115258 0
Australia
Phone 115258 0
+61 8 6488 6000
Fax 115258 0
Email 115258 0
[email protected]
Contact person for public queries
Name 115259 0
Maya Malkani
Address 115259 0
School of Psychological Science
University of Western Australia
35 Stirling Highway
Crawley, 6009
Western Australia
Country 115259 0
Australia
Phone 115259 0
+61 8 6488 6000
Fax 115259 0
Email 115259 0
[email protected]
Contact person for scientific queries
Name 115260 0
Maya Malkani
Address 115260 0
School of Psychological Science
University of Western Australia
35 Stirling Highway
Crawley, 6009
Western Australia
Country 115260 0
Australia
Phone 115260 0
+61 8 6488 6000
Fax 115260 0
Email 115260 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.