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

Nationwide Children's Hospital

Status and phase: Completed; Phase 2

Conditions: Insomnia; Autism Spectrum Disorders

Treatments: Behavioral: Telephone Care Management; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01558180

IRB11-00719

Details and patient eligibility

About

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).

Full description

Please see brief summary.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Telephone Care Management

Experimental group

Description:

calls from a registered nurse to educate caregivers about behavioral sleep strategies

Treatment:

Behavioral: Telephone Care Management

Usual Care

Placebo Comparator group

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.

Treatment:

Behavioral: Usual Care