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| Name | Class |
|---|---|
| The Ingram Foundation is funding this work. | UNKNOWN |
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The investigators will conduct a randomized controlled trial comparing a telephone based intervention (TCM) to usual care (UC). TCM will feature a registered nurse providing a series of phone calls to assist caregivers in learning and modifying behavioral strategies that may help young children with autism to sleep better. Objective (activity monitors) and subjective (rating scales) data will be collected by an independent research assistant at the end of the project. The investigators hypothesize that TCM improves sleep duration and decreases sleep problems relative to a usual care control condition (UC).
Please see brief summary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone Care Management | Experimental | calls from a registered nurse to educate caregivers about behavioral sleep strategies |
|
| Usual Care | Placebo Comparator | It's a placebo comparator because individuals in this group will receive an educational handout on behavioral sleep strategies. This handout approximates standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone Care Management | Behavioral | series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Children's Sleep Habits Questionnaire | 2 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Actigraphy (Activity Monitoring) | 2 month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jack Stevens, Ph.D. | Nationwide Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| Usual Care | Behavioral | educational handouts on pediatric insomnia |
|
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| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |