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

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ClinicalTrials.gov Identifier: NCT01558180
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : February 3, 2015
Sponsor:
Collaborator:
The Ingram Foundation is funding this work.
Information provided by (Responsible Party):
Jack Stevens, Nationwide Children's Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Autism Spectrum Disorders Insomnia Behavioral: Telephone Care Management Behavioral: Usual Care Phase 2

Detailed Description:
Please see brief summary.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : April 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015

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