Helping Young Children Sleep
This trial is active, not recruiting.
|Sponsor||Nationwide Children's Hospital|
|Start date||November 2012|
|End date||July 2016|
|Trial size||240 participants|
|Trial identifier||NCT01729715, IRB12-00439|
The investigators are conducting a randomized trial of behavioral treatments for young children with insomnia. The investigators are comparing the improvement in sleep patterns after families are given access to Internet sleep instructions compared to DVD sleep instructions.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Internet site that offers parents tips on promoting sleep in infants and toddlers
DVD that offers parents tips on promoting sleep in infants and toddlers
Brief infant sleep questionnaire
time frame: 3 weeks
Profile of mood states
time frame: 1 week
Pittsburgh sleep quality index
time frame: 1 month
Male or female participants from 6 months up to 36 months old.
Inclusion Criteria: - 6-36 months - difficulties falling asleep or staying asleep - DVD and internet access Exclusion Criteria: - Under 14 pounds - Requires nighttime feeding or parental intervention for health reasons - Chronic medical or psychological conditions such as asthma or autism - Parents prefer co-sleeping
|Official title||Helping Young Children Sleep|
|Principal investigator||Mark Splaingard, MD|
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