Harriet Hiscock1,2,3, Melissa Mulraney2,3, Helen Heussler4, Nicole Rinehart5, Tibor Schuster6,7, Anneke C Grobler3,6, Lisa Gold8, Shalika Bohingamu Mudiyanselage8, Nicole Hayes4, Emma Sciberras1,3,5. 1. Centre for Community Child Health, The Royal Children's Hospital, Parkville, VIC, Australia. 2. Health Services, Murdoch Children's Research Institute, Parkville, VIC, Australia. 3. Department of Paediatrics, University of Melbourne, Parkville, VIC, Australia. 4. Mater Research Institute, University of Queensland, Brisbane, QLD, Australia. 5. Deakin Child Study Centre, School of Psychology, Deakin University, Geelong, VIC, Australia. 6. Clinical Epidemiology and Biostatistics Unit and Melbourne Children's Trials Centre, Murdoch Children's Research Institute, Parkville, VIC, Australia. 7. Department of Family Medicine, McGill University, Montreal, QC, Canada. 8. School of Health and Social Development, Deakin University, Geelong, VIC, Australia.
Abstract
BACKGROUND: We have demonstrated the efficacy of a brief behavioral intervention for sleep in children with ADHD in a previous randomized controlled trial and now aim to examine whether this intervention is effective and cost-effective when delivered by pediatricians or psychologists in community settings. METHODS: Translational, cluster-randomized trial of a behavioral intervention versus usual care from 19th January, 2015 to 30th June, 2017. Participants (n = 361) were children aged 5-13 years with ADHD and parent report of a moderate/severe sleep problem who met criteria for American Academy of Sleep Medicine criteria for chronic insomnia disorder, delayed sleep-wake phase disorder, or were experiencing sleep-related anxiety. Participants were randomized at the level of the pediatrician (n = 61) to intervention (n = 183) or usual care (n = 178). Families in the intervention group received two consultations with a pediatrician or a psychologist covering sleep hygiene and tailored behavioral strategies. RESULTS: In an intention-to-treat analysis, at 3 and 6 months respectively, the proportion of children with moderate to severe sleep problems was lower in the intervention (28.0%, 35.8%) compared with usual care group (55.4%, 60.1%; 3 month: risk ratio (RR): 0.51, 95% CI 0.37, 0.70, p < .001; 6 month: RR: 0.58; 95% CI 0.45, 0.76, p < .001). Intervention children had improvements across multiple Children's Sleep Habits Questionnaire subscales at 3 and 6 months. No benefits of the intervention were observed in other domains. Cost-effectiveness of the intervention was AUD 13 per percentage point reduction in child sleep problem at 3 months. CONCLUSIONS: A low-cost brief behavioral sleep intervention is effective in improving sleep problems when delivered by community clinicians. Greater sample comorbidity, lower intervention dose or insufficient clinician supervisions may have contributed to the lack benefits seen in our previous trial.
RCT Entities:
BACKGROUND: We have demonstrated the efficacy of a brief behavioral intervention for sleep in children with ADHD in a previous randomized controlled trial and now aim to examine whether this intervention is effective and cost-effective when delivered by pediatricians or psychologists in community settings. METHODS: Translational, cluster-randomized trial of a behavioral intervention versus usual care from 19th January, 2015 to 30th June, 2017. Participants (n = 361) were children aged 5-13 years with ADHD and parent report of a moderate/severe sleep problem who met criteria for American Academy of Sleep Medicine criteria for chronic insomnia disorder, delayed sleep-wake phase disorder, or were experiencing sleep-related anxiety. Participants were randomized at the level of the pediatrician (n = 61) to intervention (n = 183) or usual care (n = 178). Families in the intervention group received two consultations with a pediatrician or a psychologist covering sleep hygiene and tailored behavioral strategies. RESULTS: In an intention-to-treat analysis, at 3 and 6 months respectively, the proportion of children with moderate to severe sleep problems was lower in the intervention (28.0%, 35.8%) compared with usual care group (55.4%, 60.1%; 3 month: risk ratio (RR): 0.51, 95% CI 0.37, 0.70, p < .001; 6 month: RR: 0.58; 95% CI 0.45, 0.76, p < .001). Intervention children had improvements across multiple Children's Sleep Habits Questionnaire subscales at 3 and 6 months. No benefits of the intervention were observed in other domains. Cost-effectiveness of the intervention was AUD 13 per percentage point reduction in child sleep problem at 3 months. CONCLUSIONS: A low-cost brief behavioral sleep intervention is effective in improving sleep problems when delivered by community clinicians. Greater sample comorbidity, lower intervention dose or insufficient clinician supervisions may have contributed to the lack benefits seen in our previous trial.