Sleep disorder in autism Mental and Behavioural Disorders Pervasive developmental disorders
Conditions
Interventions
This is a crossover trial, with two arms: Melatonin medication vs placebo.
Group 1: One month no medication, 3 months melatonin, 1 month washout, 3 months placebo, 1 month no medication.
Group 2: O
Sponsors
North Yorkshire and York Primary Care Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both male and female children, aged 4-10 years 2. Diagnosis of typical or atypical childhood autism and sleep disorder (as defined by World Health Organization ICD-10 and sub-classified using the International Classification of Sleep Disorders)
Exclusion criteria
Exclusion criteria: 1. Children on any other medication including anti-epileptic medication 2. Children previously on melatonin or having any other sleep disorder treatments 3. Any families who do not complete sleep diaries during the one month lead-in period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following are recorded by the family every day from the beginning of the study for 9 months: 1. Sleep latency (i.e. time to onset of sleep) 2. Number of hours sleep per night (as recorded in daily sleep diaries) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following are carried out at baseline and after 4, 8 and 9 months: 1. General Health Questionnaire 2. Sleep Difficulties Questionnaire (Likert scale) | — |
Countries
United Kingdom
Outcome results
None listed