Telephone Care Management to Address Sleep Problems in Young Children With Autism
Primary Purpose
Autism Spectrum Disorders, Insomnia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telephone Care Management
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorders
Eligibility 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
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Telephone Care Management
Usual Care
Arm Description
calls from a registered nurse to educate caregivers about behavioral sleep strategies
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.
Outcomes
Primary Outcome Measures
Children's Sleep Habits Questionnaire
Secondary Outcome Measures
Actigraphy (Activity Monitoring)
Full Information
NCT ID
NCT01558180
First Posted
March 16, 2012
Last Updated
February 2, 2015
Sponsor
Nationwide Children's Hospital
Collaborators
The Ingram Foundation is funding this work.
1. Study Identification
Unique Protocol Identification Number
NCT01558180
Brief Title
Telephone Care Management to Address Sleep Problems in Young Children With Autism
Official Title
Telephone Care Management to Address Sleep Problems in Young Children With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
The Ingram Foundation is funding this work.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Please see brief summary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telephone Care Management
Arm Type
Experimental
Arm Description
calls from a registered nurse to educate caregivers about behavioral sleep strategies
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Care Management
Other Intervention Name(s)
TCM
Intervention Description
series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Other Intervention Name(s)
UC
Intervention Description
educational handouts on pediatric insomnia
Primary Outcome Measure Information:
Title
Children's Sleep Habits Questionnaire
Time Frame
2 month follow-up
Secondary Outcome Measure Information:
Title
Actigraphy (Activity Monitoring)
Time Frame
2 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack Stevens, Ph.D.
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Telephone Care Management to Address Sleep Problems in Young Children With Autism
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