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Does the treatment of sleep problems in adolescents with ADHD improve outcomes? A pilot randomised controlled trial

Does the treatment of sleep problems in adolescents with ADHD improve outcomes? A pilot randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001195246
Enrollment
20
Registered
2018-07-17
Start date
2018-08-06
Completion date
2018-10-01
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

ADHD is an impairing neurobiological disorder affecting over 300,000 young people in Australia. Up to 70% of children with ADHD experience sleep problems which contribute to substantially worse functioning. A number of studies have now demonstrated that sleep problems are amenable to intervention in young children with ADHD, with large improvements in sleep and child and family wellbeing. This study will extend this program to adolescents with ADHD, given that sleep problems continue to be prevalent in adolescents and are associated with poorer wellbeing. There are currently no evidence-based sleep interventions for adolescents with ADHD. This study aims to conduct a pilot randomised controlled trial (RCT) to determine the feasibility, and acceptability of the adapted Sleeping Sound intervention, in adolescents aged 13-17 years with ADHD. We hypothesise that the Sleeping Sound adolescent intervention will be a feasible and acceptable treatment for sleep problems in adolescents with ADHD. We will also explore the effect of the intervention on the following outcomes at 3 and 5 months post-randomisation: 1. Adolescent sleep problems and sleep hygiene 2. ADHD symptom severity 3. Adolescent wellbeing (i.e., mental health and quality of life) 4. Parent mental health

Interventions

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.

Sponsors

Dr. Emma Sciberras
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026