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document
Controlled-release melatonin , singly and combined with cognitive behavioural therapy , for persistent insomnia in children with autism spectrum disorders : a randomized placebo-controlled trial . Although melatonin and cognitive-behavioural therapy have shown efficacy in treating sleep disorders in children with autism spectrum disorders , little is known about their relative or combined efficacy . One hundred and sixty children with autism spectrum disorders , aged 4-10 years , suffering from sleep onset insomnia and impaired sleep maintenance , were assigned randomly to either ( 1 ) combination of controlled-release melatonin and cognitive-behavioural therapy ; ( 2 ) controlled-release melatonin ; ( 3 ) four sessions of cognitive-behavioural therapy ; or ( 4 ) placebo drug treatment condition for 12 weeks in a 1 : 1 : 1 : 1 ratio . Children were studied at baseline and after 12 weeks of treatment . Treatment response was assessed with 1-week actigraphic monitoring , sleep diary and sleep questionnaire . Main outcome measures , derived actigraphically , were sleep latency , total sleep time , wake after sleep onset and number of awakenings . The active treatment groups all resulted in improvements across all outcome measures , with moderate-to-large effect sizes from baseline to a 12-week assessment . Melatonin treatment was mainly effective in reducing insomnia symptoms , while cognitive-behavioural therapy had a light positive impact mainly on sleep latency , suggesting that some behavioural aspects might play a role in determining initial insomnia . The combination treatment group showed a trend to outperform other active treatment groups , with fewer dropouts and a greater proportion of treatment responders achieving clinically significant changes ( 63.38 % normative sleep efficiency criterion of > 85 % and 84.62 % , sleep onset latency < 30 min ) . This study demonstrates that adding behavioural intervention to melatonin treatment seems to result in a better treatment response , at least in the short term .
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Intervention_Pharmacological
melatonin
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Intervention_Psychological
singly and combined with cognitive behavioural therapy
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Intervention_Pharmacological
melatonin
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Intervention_Psychological
cognitive-behavioural therapy
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Intervention_Pharmacological
controlled-release melatonin
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Intervention_Educational
cognitive-behavioural therapy
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Intervention_Pharmacological
controlled-release melatonin
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Intervention_Educational
four sessions of cognitive-behavioural therapy
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Intervention_Control
placebo drug treatment condition
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Intervention_Pharmacological
Melatonin
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Intervention_Psychological
cognitive-behavioural therapy
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Intervention_Educational
behavioural intervention
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Intervention_Pharmacological
melatonin
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Outcome_Physical
sleep latency , total sleep time , wake after sleep onset and number of awakenings
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Outcome_Physical
insomnia symptoms
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Outcome_Physical
sleep latency
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Outcome_Physical
initial insomnia
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Participant_Condition
insomnia
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Participant_Age
children
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Participant_Condition
autism spectrum disorders
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Participant_Condition
autism spectrum disorders
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Participant_Sample-size
One hundred and sixty
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Participant_Condition
autism spectrum disorders
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Participant_Age
aged 4-10 years
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Participant_Condition
sleep onset insomnia and impaired sleep maintenance