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

This study is currently recruiting participants.
Verified August 2013 by Nationwide Children's Hospital
Sponsor:
Collaborator:
The Ingram Foundation is funding this work.
Information provided by (Responsible Party):
Jack Stevens, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01558180
First received: March 16, 2012
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 Nationwide Children's Hospital:

Primary Outcome Measures:
  • Children's Sleep Habits Questionnaire [ Time Frame: 2 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Actigraphy (Activity Monitoring) [ Time Frame: 2 month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 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.

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01558180

Contacts
Contact: Jack H Stevens, Ph.D. 614-355-2921 Jack.Stevens@nationwidechildrens.org

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

No publications provided

Responsible Party: Jack Stevens, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01558180     History of Changes
Other Study ID Numbers: IRB11-00719
Study First Received: March 16, 2012
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Autistic Disorder
Dyssomnias
Sleep Disorders
Parasomnias
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014