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

February 2, 2015 updated by: Jack Stevens, Nationwide Children's Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Please see brief summary.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • UC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Children's Sleep Habits Questionnaire
Time Frame: 2 month follow-up
2 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Actigraphy (Activity Monitoring)
Time Frame: 2 month follow up
2 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Collaborators

The Ingram Foundation is funding this work.

Investigators

  • Principal Investigator: Jack Stevens, Ph.D., Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 20, 2012

Study Record Updates

Last Update Posted (Estimate)

February 3, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB11-00719

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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