Telephone Care Management to Address Sleep Problems in Young Children With Autism

Completed · Phase 2

Conditions studied: Autism Spectrum Disorders, Insomnia

In brief

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).

Key facts

Study ID

NCT01558180

Run by

Nationwide Children's Hospital

People needed

60

Starts

2012-04-01

Expected to finish

2013-12-01

Last updated by the study team

2015-02-03

Who can join

Age: 3 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Insomnia
• Autism Spectrum Disorder
• Regular telephone service for caregiver
• Stable dose of medication

You may not qualify if…

• Signs of obstructive sleep apnea (e.g., turning blue or stop breathing at night, recurrent snoring)
• Receptive language skills under 18 months

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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