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

This study has been completed.
The Ingram Foundation is funding this work.
Information provided by (Responsible Party):
Jack Stevens, Nationwide Children's Hospital Identifier:
First received: March 16, 2012
Last updated: February 2, 2015
Last verified: February 2015
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).

Condition Intervention Phase
Autism Spectrum Disorders Insomnia Behavioral: Telephone Care Management Behavioral: Usual Care Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telephone Care Management to Address Sleep Problems in Young Children With Autism

Resource links provided by NLM:

Further study details as provided by Jack Stevens, Nationwide Children's Hospital:

Primary Outcome Measures:
  • Children's Sleep Habits Questionnaire [ Time Frame: 2 month follow-up ]

Secondary Outcome Measures:
  • Actigraphy (Activity Monitoring) [ Time Frame: 2 month follow up ]

Estimated Enrollment: 60
Study Start Date: April 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telephone Care Management
calls from a registered nurse to educate caregivers about behavioral sleep strategies
Behavioral: Telephone Care Management
series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia
Other Name: TCM
Placebo Comparator: Usual Care
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
educational handouts on pediatric insomnia
Other Name: UC

Detailed Description:
Please see brief summary.

Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Insomnia
  2. Autism Spectrum Disorder
  3. Regular telephone service for caregiver
  4. Stable dose of medication

Exclusion Criteria:

  1. Signs of obstructive sleep apnea (e.g., turning blue or stop breathing at night, recurrent snoring)
  2. Receptive language skills under 18 months
  Contacts and Locations
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Please refer to this study by its identifier: NCT01558180

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
The Ingram Foundation is funding this work.
Principal Investigator: Jack Stevens, Ph.D. Nationwide Children's Hospital
  More Information

Responsible Party: Jack Stevens, Principal Investigator, Nationwide Children's Hospital Identifier: NCT01558180     History of Changes
Other Study ID Numbers: IRB11-00719
Study First Received: March 16, 2012
Last Updated: February 2, 2015

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Sleep Wake Disorders
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on September 21, 2017