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Trial registered on ANZCTR


Registration number
ACTRN12618001195246
Ethics application status
Approved
Date submitted
16/07/2018
Date registered
17/07/2018
Date last updated
30/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the treatment of sleep problems in adolescents with ADHD improve outcomes? A pilot randomised controlled trial
Scientific title
Does the treatment of sleep problems in adolescents with ADHD improve outcomes? A pilot randomised controlled trial
Secondary ID [1] 295564 0
None
Universal Trial Number (UTN)
U1111-1217-4944
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention-Deficit/Hyperactivity Disorder 308833 0
Sleep Problems (Chronic Insomnia Disorder and/or Delayed Sleep-Wake Phase Disorder) 308834 0
Condition category
Condition code
Mental Health 307764 307764 0 0
Other mental health disorders
Mental Health 307765 307765 0 0
Studies of normal psychology, cognitive function and behaviour

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).

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, and will be delivered by study-employed psychologists (generalist or clinical). Face-to-face sessions will primarily take place at Deakin University. However, families will also be given the option to partake in face-to-face sessions either at home or their paediatrician’s (or psychologist’s) clinic/practice.

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.



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.

Sciberras, E., Mulraney, M., Heussler, H., Rinehart, N., Schuster, T., Gold, L., . . . Hiscock, H. (2017). Does a brief, behavioural intervention, delivered by paediatricians or psychologists improve sleep problems for children with ADHD? Protocol for a cluster-randomised, translational trial. BMJ open, 7(4), e014158.
Intervention code [1] 301867 0
Behaviour
Intervention code [2] 301868 0
Treatment: Other
Comparator / control treatment
The usual care group will continue to receive care from their paediatrician (and can access other treatments) but will not receive the Sleeping Sound intervention. Usual care is defined in this study as participants keeping up with their current medication routines and any appointments (with paediatricians, psychologists or other health professionals) that are part of their regular routine.
Control group
Active

Outcomes
Primary outcome [1] 306765 0
Feasibility and acceptability of treating sleep problems in adolescents with ADHD
Timepoint [1] 306765 0
Three months post randomisation
Secondary outcome [1] 349524 0
Adolescent sleep quality as recorded using the Adolescent Sleep Wake Scale (adolescent report)
Timepoint [1] 349524 0
Baseline, three months and five months post randomisation.
Secondary outcome [2] 349525 0
Adolescent sleep disturbance scores as recorded using the Sleep Disturbance Scale for Children (parent report)
Timepoint [2] 349525 0
Baseline, three months and five months post randomisation.
Secondary outcome [3] 349526 0
Adolescent daytime sleepiness scores as recorded using the Epworth Sleepiness Scale - Child and Adolescent version (both adolescent and parent report).
Timepoint [3] 349526 0
Baseline, three months and five months post randomisation
Secondary outcome [4] 349527 0
Global rating of sleep problem severity, rated as no, mild, moderate or severe (adolescent and parent report)
Timepoint [4] 349527 0
Baseline, three months and five months post randomisation
Secondary outcome [5] 349528 0
Healthy sleep practices as recorded using the Adolescent Sleep Hygiene Scale (adolescent report)
Timepoint [5] 349528 0
Baseline, three months and five months post randomisation
Secondary outcome [6] 349529 0
Adolescent ADHD symptoms as recorded using the ADHD Rating Scale IV (both adolescent and parent report)
Timepoint [6] 349529 0
Baseline, three months and five months post randomisation
Secondary outcome [7] 349530 0
Adolescent mental health as recorded using the Strengths and Difficulties Questionnaire (both adolescent and parent report)
Timepoint [7] 349530 0
Baseline, three months and five months post randomisation
Secondary outcome [8] 349531 0
Adolescent irritability as recorded using the Affective Reactivity Index (both adolescent and parent report)
Timepoint [8] 349531 0
Baseline, three months and five months post randomisation
Secondary outcome [9] 349532 0
Adolescent's quality of life as recorded using the Child Healthy Utility 9D (adolescent report)
Timepoint [9] 349532 0
Baseline, three months and five months post randomisation
Secondary outcome [10] 349533 0
Parent mental health as recorded using the Kessler 6 Scale (parent report)
Timepoint [10] 349533 0
Baseline, three months and five months post randomisation

Eligibility
Key inclusion criteria
For Adolescent Participants:
1. DSM-5 criteria for ADHD as identified by parent/caregiver screening using the 18-item ADHD Rating Scale IV (a validated scale measuring core ADHD symptoms). Parents will be 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).

3. Adolescent aged between 13 and 17 years

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.

For Parent Participants:
No key inclusion criteria specified.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Families of adolescents with a major medical condition (e.g., cerebral palsy, epilepsy, Fragile X disorder).
2. Families of adolescents that have obstructive sleep apnoea.
3. Families of adolescents with an intellectual disability.
4. Families of adolescents who are currently receiving structured-behavioural management or treatment for their sleep difficulties.
5. 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)
Eligibility for participation will be determined over the phone through a screening process conducted with both parent and the adolescent. Phone screening will take approximately 30 minutes to complete. If the adolescent is eligible, and both parent and adolescent provide consent to partake in the study (through online procedures), they will each be asked to individually complete a baseline survey through the REDCap online platform. These surveys will take both parent and adolescent approximately 30 minutes to complete. Once these baseline surveys have been completed (by both the adolescent and their parent), the family will be randomised to either the intervention or the usual care (control) group. Randomisation will be generated by a computerised sequence loaded into the REDCap online platform.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a small pilot study which aims to examine the feasibility of delivering the Sleeping Sound intervention to adolescents. For the current pilot, we aim to recruit 20 families (10 intervention, 10 usual care). Analyses will be conducted on an intention-to-treat basis. Descriptive statistics will be used to summarize the acceptability and feasibility of the intervention (primary outcome). Linear and logistic regression will be used to examine secondary outcomes taking into account baseline functioning. Given the proof-of-principle nature of this study, it will focus on effect sizes (Cohen’s d) rather than statistical significance testing.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/08/2018
Actual
Date of last participant enrolment
Anticipated
1/10/2018
Actual
Date of last data collection
Anticipated
25/03/2019
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300140 0
Charities/Societies/Foundations
Name [1] 300140 0
veski
Country [1] 300140 0
Australia
Primary sponsor type
Individual
Name
Dr. Emma Sciberras
Address
School of Psychology
Deakin University, Melbourne Burwood Campus
221 Burwood Hwy 3125, Victoria, AUSTRALIA
Country
Australia
Secondary sponsor category [1] 299542 0
None
Name [1] 299542 0
Address [1] 299542 0
Country [1] 299542 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300973 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 300973 0
Ethics committee country [1] 300973 0
Australia
Date submitted for ethics approval [1] 300973 0
24/04/2018
Approval date [1] 300973 0
06/06/2018
Ethics approval number [1] 300973 0
2018-135

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

Contacts
Principal investigator
Name 85474 0
Dr Emma Sciberras
Address 85474 0
School of Psychology,
Deakin University, Melbourne Burwood Campus
221 Burwood Highway, Burwood, 3125, VIC
Country 85474 0
Australia
Phone 85474 0
+61 3 9251 7222
Fax 85474 0
Email 85474 0
emma.sciberras@deakin.edu.au
Contact person for public queries
Name 85475 0
Jeremy Quek
Address 85475 0
School of Psychology,
Deakin University, Melbourne Burwood Campus
221 Burwood Highway, Burwood, 3125, VIC
Country 85475 0
Australia
Phone 85475 0
+61 3 9246 8743
Fax 85475 0
Email 85475 0
jeremy.quek@deakin.edu.au
Contact person for scientific queries
Name 85476 0
Emma Sciberras
Address 85476 0
School of Psychology,
Deakin University, Melbourne Burwood Campus
221 Burwood Highway, Burwood, 3125, VIC
Country 85476 0
Australia
Phone 85476 0
+61 3 9251 7222
Fax 85476 0
Email 85476 0
emma.sciberras@deakin.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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