Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000374965
Ethics application status
Approved
Date submitted
5/03/2020
Date registered
17/03/2020
Date last updated
17/03/2020
Date data sharing statement initially provided
17/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleeping Sound in Adolescence: A research project aiming to improve sleep in adolescents with ADHD.
Scientific title
Does the treatment of sleep problems in adolescents with ADHD improve outcomes? A randomised controlled trial.
Secondary ID [1] 300012 0
None
Universal Trial Number (UTN)
U1111-1247-5806
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit/Hyperactivity Disorder 316025 0
Sleep Problems (Chronic Insomnia and/or Delayed Sleep-Wake Phase Disorder) 316026 0
Condition category
Condition code
Mental Health 314302 314302 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an adolescent adaptation of the Sleeping Sound Program, a behavioural sleep intervention, which has been evaluated with young children with ADHD and sleep problems (Hiscock et al., 2015; Sciberras et al., 2017). The program has been adapted to include modules that are relevant to the sleep problems experienced by adolescents with ADHD.

Intervention materials will include: (1) a sleep diary for adolescent participants to complete, (2) information handouts about normal sleep, sleep cycles and healthy sleep strategies and (3) further information (via handouts) regarding specific sleep difficulties that may be relevant to the adolescent participant (e.g., insomnia, delayed sleep phase). These handouts have been specifically designed for this study.

The program will include two 50-minute face-to-face sessions, held a fortnight apart and a follow-up phone call to both adolescents and their parents a fortnight later. The intervention will be provided individually to each family. The intervention will be delivered by study psychologists trained in the intervention by principal investigator and clinical psychologist Dr Emma Sciberras and supported by the investigator team. Face-to-face sessions will take place at Deakin University.

Intervention Procedures:

The first session will focus on an assessment of the adolescent’s sleep problem, providing information about normal sleep and sleep cycles, giving the adolescent a sleep diary to complete, advice about healthy sleep practices, and a plan specifically tailored to the adolescent’s sleep problem.

The second session will include a review of the sleep diary, re-enforcement/trouble shooting of existing strategies and the introduction of new strategies where appropriate. Adolescents and their parents will be called a fortnight later to again monitor progress and offer any final strategies.

Treatment fidelity will be maximised and assessed through: (1) fortnightly supervision meetings with clinicians led by principal investigator and clinical psychologist, Dr Emma Sciberras and (2) a standardised consultation record form to be kept by clinicians for each session including the presenting sleep diagnosis, medication use, comorbidities, and treatment progress.

References:
Hiscock, H., Sciberras, E., Mensah, F., Gerner, B., Efron, D., Khano, S., & Oberklaid, F. (2015). Impact of a behavioral sleep intervention on ADHD symptoms, child sleep and parent health: a randomized controlled trial. BMJ, 350, h68.
Hiscock H, Mulraney M, Heussler H, Rinehart N, Schuster T, Grobler AC, Gold L, Bohingamu Mudiyanselage S, Hayes N, Sciberras E. Impact of a behavioral intervention, delivered by pediatricians or psychologists, on sleep problems in children with ADHD: a cluster-randomized, translational trial. J Child Psychol Psychiatry 2019; 60:1230-1241.
Sciberras E, Mulraney M, Mensah F, Efron D, Oberklaid F, Hiscock H. Sustained impact of a sleep intervention and moderators of treatment outcome for children with ADHD: A randomized controlled trial. Psychological Medicine 2020; 50: 210-19.
Intervention code [1] 316686 0
Behaviour
Comparator / control treatment
Usual Care control group. Usual care is defined in this study as participants keeping up with their current medication and routines and any appointments (with paediatricians, psychologists or other health professionals) that are part of their regular routine. The usual care group can access other treatments during their participation in the study, but will not receive the Sleeping Sound intervention.
Control group
Active

Outcomes
Primary outcome [1] 322692 0
Adolescent sleep quality assessed using the Adolescent Sleep Wake Scale, total score (adolescent report)
Timepoint [1] 322692 0
Baseline and 3 months post-randomisation
Secondary outcome [1] 379309 0
Adolescent sleep duration as assessed by 7 nights of actigraphy measurement using the Respironics Actiwatch 2 wearable device
Timepoint [1] 379309 0
Baseline and 3 months post-randomisation
Secondary outcome [2] 379310 0
Adolescent night waking as assessed by 7 nights of actigraphy measurement using the Respironics Actiwatch 2 wearable device
Timepoint [2] 379310 0
Baseline and 3 months post-randomisation
Secondary outcome [3] 379313 0
Adolescent sleep efficiency as assessed by 7 nights of actigraphy measurement using the Respironics Actiwatch 2 wearable device
Timepoint [3] 379313 0
Baseline and 3 months post-randomisation
Secondary outcome [4] 379314 0
Adolescent sleep quality assessed using the Adolescent Sleep Wake Scale, subscales (adolescent report)
Timepoint [4] 379314 0
Baseline and 3 months post-randomisation
Secondary outcome [5] 379315 0
Adolescent sleep disturbance assessed using the Sleep Disturbance Scale for Children (parent report)
Timepoint [5] 379315 0
Baseline and 3 months post-randomisation
Secondary outcome [6] 379316 0
Adolescent sleepiness assessed using the Epworth Sleepiness Scale (adolescent and parent report)
Timepoint [6] 379316 0
Baseline and 3 months post-randomisation
Secondary outcome [7] 379317 0
Global sleep rating assessed using a study designed question which rates the severity of the adolescent's sleep problem (adolescent and parent report)
Timepoint [7] 379317 0
Baseline and 3 months post-randomisation
Secondary outcome [8] 379318 0
Adolescent sleep hygiene assessed using the Adolescent Sleep Hygiene Scale (adolescent report)
Timepoint [8] 379318 0
Baseline and 3 months post-randomisation
Secondary outcome [9] 379319 0
Adolescent ADHD symptoms assessed using the ADHD Rating Scale IV (adolescent and parent report)
Timepoint [9] 379319 0
Baseline and 3 months post-randomisation
Secondary outcome [10] 379320 0
Adolescent mental health assessed using the Strengths and Difficulties Questionnaire (adolescent and parent report)
Timepoint [10] 379320 0
Baseline and 3 months post-randomisation
Secondary outcome [11] 379321 0
Adolescent irritability assessed using the Affective Reactivity Index (adolescent and parent report)
Timepoint [11] 379321 0
Baseline and 3 months post-randomisation
Secondary outcome [12] 380084 0
Adolescent emotion regulation assessed using the Difficulties in Emotion Regulation Scale (adolescent and parent report)
Timepoint [12] 380084 0
Baseline and 3 months post-randomisation
Secondary outcome [13] 381203 0
Adolescent quality of life assessed using the Child Health Utility-9 Dimension (adolescent report)
Timepoint [13] 381203 0
Baseline and 3 months post-randomisation
Secondary outcome [14] 381204 0
Parent mental health assessed using the Kessler 6 (parent report)
Timepoint [14] 381204 0
Baseline and 3 months post-randomisation

Eligibility
Key inclusion criteria
1. Adolescent has been previously diagnosed with ADHD and currently meets DSM-5 criteria for ADHD as assessed using the ADHD Rating Scale IV. During the screening interview parents will be administered the ADHD Rating Scale and asked to rate their adolescent's behaviour when not on stimulant medication. As per DSM 5 criteria, parents will need to endorse at least 6/9 Inattention and/or 6/9 Hyperactivity/impulsivity symptoms, symptom duration of at least 6 months, age of onset prior to 12 years, and evidence of impairment across settings.

2. Both parent AND adolescent report that the adolescent has a mild, moderate or severe sleep problem that fulfils criteria for chronic insomnia disorder and/or delayed sleep-wake phase disorder according to the American Academy of Sleep Medicine, International Classification of Sleep Disorders (3rd Edition).


Adolescent participants currently taking melatonin, as well as any other medications (SSRI’s etc.), will be included in the trial if they continue to meet the above eligibility criteria.
Minimum age
13 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Adolescents with a major medical condition (e.g., cerebral palsy, Fragile X disorder)
2. Adolescents with obstructive sleep apnoea.
3. Adolescents with an intellectual disability.
4. Adolescents with current suicidality, psychosis or mania
5. Adolescents who are currently receiving psychosocial treatment for their sleep difficulties.
6. Non-English speaking families.

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 screening and baseline measures have been completed. Randomisation will be performed by a researcher independent of the project using a web-based randomisation schedule. Members of the research team do not have access to the randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule will be pre- generated using block randomisation with variable block sizes by an independent research statistician, and loaded into the REDCap online platform. Randomisation will be stratified by gender to ensure similar proportions of males and females across groups. Eligible siblings will be randomised to the same group to avoid contamination.
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
This trial is powered to detect a 0.53 SD improvement in adolescent-reported sleep problems. To achieve 80% power for a 0.53 SD difference at 3 months with a two-sided test with alpha =0.05 and anticipated 20% drop out, we will need to enrol 70 adolescents in each arm (140 total adolescents). This estimate also accounts for a clustering effect per recruitment site of .08 based on recruiting 4 participants per paediatrician practice.

All analyses will be conducted on an intention-to-treat basis. To account for loss to follow-up, analysis of the primary outcome (Adolescent Sleep Wake Scale) and all secondary outcomes will be carried out using mixed effects regression. For each outcome, a single mixed effects model will be fitted incorporating baseline and 3 month data using random effects to allow for the repeated measures within an individual. This approach implicitly deals with missing data as it enables all participants with baseline data to be included in the analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2020
Actual
Date of last participant enrolment
Anticipated
28/02/2021
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 304470 0
Charities/Societies/Foundations
Name [1] 304470 0
Waterloo Foundation
Country [1] 304470 0
United Kingdom
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, 3125, Victoria, Australia
Country
Australia
Secondary sponsor category [1] 305151 0
None
Name [1] 305151 0
Address [1] 305151 0
Country [1] 305151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304898 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 304898 0
Ethics committee country [1] 304898 0
Australia
Date submitted for ethics approval [1] 304898 0
31/08/2019
Approval date [1] 304898 0
31/10/2019
Ethics approval number [1] 304898 0
2019-342

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

Contacts
Principal investigator
Name 98574 0
A/Prof Emma Sciberras
Address 98574 0
School of Psychology,
Deakin University, Melbourne Burwood Campus
221 Burwood Highway, Burwood, 3125, VIC
Country 98574 0
Australia
Phone 98574 0
+61 3 9251 7222
Fax 98574 0
Email 98574 0
[email protected]
Contact person for public queries
Name 98575 0
Emma Sciberras
Address 98575 0
School of Psychology,
Deakin University, Melbourne Burwood Campus
221 Burwood Highway, Burwood, 3125, VIC
Country 98575 0
Australia
Phone 98575 0
+61 3 9246 8806
Fax 98575 0
Email 98575 0
[email protected]
Contact person for scientific queries
Name 98576 0
Emma Sciberras
Address 98576 0
School of Psychology,
Deakin University, Melbourne Burwood Campus
221 Burwood Highway, Burwood, 3125, VIC
Country 98576 0
Australia
Phone 98576 0
+61 3 9251 7222
Fax 98576 0
Email 98576 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.