Skip to main content
OpenTrials
Completed

NCT Number: NCT01558180

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorders Autism Spectrum Disorder Child Development Disorders, Pervasive Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

Please see brief summary.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Insomnia
  • 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

Treatment and study plan

Telephone Care Management

Behavioral

series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia

Other names: TCM

Usual Care

Behavioral

educational handouts on pediatric insomnia

Other names: UC

Primary outcomes

  1. Children's Sleep Habits Questionnaire

    Time frame: 2 month follow-up

Secondary outcomes

  1. Actigraphy (Activity Monitoring)

    Time frame: 2 month follow up

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Collaborators

  • The Ingram Foundation is funding this work.

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2012
Registry last updated
Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.