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Clinical Trials/NCT01558180
NCT01558180
Completed
Phase 2

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

Nationwide Children's Hospital1 site in 1 country60 target enrollmentApril 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Autism Spectrum Disorders
Sponsor
Nationwide Children's Hospital
Enrollment
60
Locations
1
Primary Endpoint
Children's Sleep Habits Questionnaire
Status
Completed
Last Updated
11 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
December 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jack Stevens

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Children's Sleep Habits Questionnaire

Time Frame: 2 month follow-up

Secondary Outcomes

  • Actigraphy (Activity Monitoring)(2 month follow up)

Study Sites (1)

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