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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autism Spectrum Disorders Insomnia | Behavioral: Telephone Care Management Behavioral: Usual Care | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Telephone Care Management
calls from a registered nurse to educate caregivers about behavioral sleep strategies
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Behavioral: Telephone Care Management
series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia
Other Name: TCM
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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.
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Behavioral: Usual Care
educational handouts on pediatric insomnia
Other Name: UC
|
- Children's Sleep Habits Questionnaire [ Time Frame: 2 month follow-up ]
- Actigraphy (Activity Monitoring) [ Time Frame: 2 month follow up ]

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Ages Eligible for Study: | 3 Years to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 |
Principal Investigator: | Jack Stevens, Ph.D. | Nationwide Children's Hospital |
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 |