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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01558180
Other study ID # IRB11-00719
Secondary ID
Status Completed
Phase Phase 2
First received March 16, 2012
Last updated February 2, 2015
Start date April 2012
Est. completion date December 2013

Study information

Verified date February 2015
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


Description:

Please see brief summary.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 6 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Telephone Care Management
series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia
Usual Care
educational handouts on pediatric insomnia

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Nationwide Children's Hospital The Ingram Foundation is funding this work.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Children's Sleep Habits Questionnaire 2 month follow-up No
Secondary Actigraphy (Activity Monitoring) 2 month follow up No
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