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

Phase 2

Completed

• Conditions: Autism Spectrum Disorders; Insomnia
• Interventions: Behavioral: Telephone Care Management; Behavioral: Usual Care

• Registration Number: NCT01558180
• Lead Sponsor: Nationwide Children's Hospital

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.

Study Timeline

• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Study Start: 2012-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telephone Care Management	Telephone Care Management	calls from a registered nurse to educate caregivers about behavioral sleep strategies
Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Children's Sleep Habits Questionnaire	2 month follow-up

Secondary Outcome Measures

Name	Time	Method
Actigraphy (Activity Monitoring)	2 month follow up

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States