View Clinical Trial (Medical Research Study)
Telephone Care Management to Address Sleep Problems in Young Children With Autism
| City: |
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Columbus |
| State: |
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Ohio |
| Zip Code: |
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43205 |
| Conditions: |
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Autism Spectrum Disorders - Insomnia |
| Purpose: |
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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).
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| Study Summary: |
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Please see brief summary.
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| Criteria: |
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Inclusion Criteria:
1. Insomnia
2. Autism Spectrum Disorder
3. Regular telephone service for caregiver
4. Stable dose of medication
Exclusion Criteria:
1. Signs of obstructive sleep apnea (e.g., turning blue or stop breathing at night,
recurrent snoring)
2. Receptive language skills under 18 months
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| NCT ID: |
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NCT01558180 |
| Primary Contact: |
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Principal Investigator Jack Stevens, Ph.D. Nationwide Children's Hospital
Jack H Stevens, Ph.D. Phone: 614-355-2921 Email: Jack.Stevens@nationwidechildrens.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Columbus, Ohio 43205 United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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