Protocol MelatoSom-Kids-PTSD: sleep disturbances in children and adolescents with post-traumatic stress disorder (PTSD) - a randomized double-blind placebo-controlled trial to investigate the efficacy of paediatric prolonged-release melatonin
Abstract
Introduction: Sleep disorders in the insomnia spectrum, as well as nightmares, are among the most sensitive and persistent symptoms in children with post-traumatic stress disorder (PTSD). There is currently no reference treatment or specific pharmacological treatment recommendation on the management of sleep disturbances in children and adolescents suffering from PTSD, despite the fact that they have a significant effect on daytime functioning and overall mental health of children as well as on family's health and quality of life. In this respect, paediatric prolonged-release melatonin (PedPRM) has shown significant beneficial effects on insomnia disorders in children with autism spectrum disorders and positive effects on anxiety and depressive symptomatology. Our study will be the first randomized controlled trial to examine the efficacy of PedPRM melatonin on sleep disorders in children and adolescents with PTSD, as well as on PTSD symptoms, associated daytime functioning and overall mental health in these children and their caregivers.Methods/design: The MelatoSOM-Kids-PTSD study (French national hospital-based clinical research programme) will be a multi-centre prospective double-blind placebo-controlled parallel group clinical trial investigating the efficacy of paediatric prolonged-release melatonin to alleviate sleep disturbances in children and adolescents with PTSD (120 participants recruited over a 24-month period). The experimental group will be treated with…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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