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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558180
• Other study ID #: IRB11-00719
• 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

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive
• Dyssomnias
• Insomnia
• Parasomnias
• Sleep Disorders

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