| Registry | NCT01729715 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 240 (Actual) |
| Sponsor | Nationwide Children's Hospital (Other) |
| Conditions | Insomnia |
| Interventions | Internet, DVD (Behavioral) |
| Dates | start 2012-11-01, primary completion 2015-11-01, completion 2017-03-01, first posted 2012-11-20, last updated 2017-07-21 |
| Locations | 1 site in United States |
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All trials for Insomnia All trials of Internet All trials of DVD
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Internet | Experimental | Behavioral: Internet | Internet site that offers parents tips on promoting sleep in infants and toddlers |
| DVD | Experimental | Behavioral: DVD | DVD that offers parents tips on promoting sleep in infants and toddlers |
| No treatment | No intervention |
Sex: All, ages: 6 Months to 36 Months, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Nationwide Children's Hospital | Columbus, Ohio | United States |