Melatonin treatment for sleep problems in children with autism: a randomised controlled crossover trial

Completed

• Conditions: Sleep disorder in autism; Mental and Behavioural Disorders; Pervasive developmental disorders

• Registration Number: ISRCTN77884120
• Lead Sponsor: orth Yorkshire and York Primary Care Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following are recorded by the family every day from the beginning of the study for 9 months:<br>1. Sleep latency (i.e. time to onset of sleep) <br>2. Number of hours sleep per night (as recorded in daily sleep diaries)

Secondary Outcome Measures

Name	Time	Method
The following are carried out at baseline and after 4, 8 and 9 months:<br>1. General Health Questionnaire <br>2. Sleep Difficulties Questionnaire (Likert scale)