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

This study has been completed.

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: February 2, 2015

Last verified: February 2015

History of Changes

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:

MedlinePlus related topics: Sleep Disorders

U.S. FDA Resources

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
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.

Eligibility


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

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


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.

Investigators


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

More Information


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:	February 2, 2015
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Autistic Disorder Autism Spectrum Disorder Dyssomnias Sleep Wake Disorders Parasomnias Child Development Disorders, Pervasive	Neurodevelopmental Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Signs and Symptoms

ClinicalTrials.gov processed this record on September 27, 2016

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