Trials / Completed
CompletedNCT01558180
Telephone Care Management to Address Sleep Problems in Young Children With Autism
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Nationwide Children's Hospital · Academic / Other
- Sex
- All
- Age
- 3 Years – 6 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
Please see brief summary.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Telephone Care Management | series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia |
| BEHAVIORAL | Usual Care | educational handouts on pediatric insomnia |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2012-03-20
- Last updated
- 2015-02-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01558180. Inclusion in this directory is not an endorsement.