Sleep IntervEntion as Symptom Treatment for ADHD (SIESTA)-Blended CBT sleep intervention to improve sleep, ADHD symptoms and related problems in adolescents with ADHD: Protocol for a randomised controlled trial.

INTRODUCTION: Adolescents with attention deficit hyperactivity disorder (ADHD) experience a more disrupted sleep and more sleep problems compared with typically developing adolescents. This is particularly concerning, because disrupted sleep is related to worsened clinical, neurocognitive and functional outcomes and leads to increased ADHD symptom impairment. Due to the specific difficulties adolescents with ADHD experience, a tailored sleep treatment is needed. Therefore, our lab developed a cognitive behavioural treatment-Sleep IntervEntion as Sympom Treatment for ADHD (SIESTA)-that integrates sleep training with motivational interviewing, and planning/organisational skills training with the aim of improving sleep problems in adolescents with ADHD. METHODS AND ANALYSIS: A randomised, controlled, investigator-blinded monocentre trial is used to test whether SIESTA in combination with treatment as usual (TAU) for ADHD results in greater improvement in sleep problems than TAU only. Adolescents (aged 13-17 years) with ADHD and sleep problems are included. They complete measurements before treatment (pre-test), approximately 7 weeks after the pre-test (post-test), and approximately 3 months after the post-test (follow-up). The assessment includes questionnaires filled out by adolescents, parents and teachers. Additionally, sleep is assessed by actigraphy and sleep diaries at all time-points. Primary outcomes include objectively and subjectively measured sleep architecture (specified as total sleep time, sleep onset latency, sleep efficiency and number of awakenings), subjectively measured sleep problems and sleep hygiene. Secondary outcomes include ADHD symptoms, comorbidities and functional outcomes. To analyse the data, a linear mixed effects model will be used with an intent-to-treat approach. ETHICS AND DISSEMINATION: The study activities, informed consent and assent forms have been approved by the Ethical Committee Research UZ/KU Leuven (study ID S64197). If proven effective, the intervention will be implemented throughout Flanders. Therefore, an advisory board consisting of societal partners in healthcare is appointed at the start of the project, giving advice throughout the project and assistance with implementation afterwards. TRIAL REGISTRATION NUMBER: NCT04723719.