A Phase 2 interventional study of Telephone Care Management and Usual Care in Autism Spectrum Disorders and Insomnia, sponsored by Nationwide Children's Hospital. Completed at 1 site in United States. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2015-02-03.
Sponsored by Nationwide Children's Hospital · Phase 2, Interventional, and Treatment
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.
324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 251 interventional studies indexed under Dyssomnias.
Browse Dyssomnias studies →Nationwide Children's Hospital is the lead sponsor of 231 studies on the registry; 43 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 8 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
calls from a registered nurse to educate caregivers about behavioral sleep strategies
Behavioral: Telephone Care Management
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.
Behavioral: Usual Care
series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia
Also known as: TCM
educational handouts on pediatric insomnia
Also known as: UC
Children's Sleep Habits Questionnaire
Time frame: 2 month follow-up
Actigraphy (Activity Monitoring)
Time frame: 2 month follow up
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Nationwide Children's Hospital