This trial is active, not recruiting.

Condition insomnia
Treatments internet, dvd
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
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
(No Intervention)

Primary Outcomes

Brief infant sleep questionnaire
time frame: 3 weeks

Secondary Outcomes

Profile of mood states
time frame: 1 week
Pittsburgh sleep quality index
time frame: 1 month

Eligibility Criteria

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

Additional Information

Official title Helping Young Children Sleep
Principal investigator Mark Splaingard, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Nationwide Children's Hospital.