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

NCT ID: NCT01558180

Last Updated: 2015-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-12-31

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.

Conditions

Autism Spectrum Disorders; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telephone Care Management

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

Group Type: EXPERIMENTAL

Telephone Care Management

Intervention Type: BEHAVIORAL

series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia

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.

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

educational handouts on pediatric insomnia

Interventions

Telephone Care Management

series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia

Intervention Type: BEHAVIORAL

Usual Care

educational handouts on pediatric insomnia

Intervention Type: BEHAVIORAL

Other Intervention Names

TCM; UC

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Ingram Foundation is funding this work.

UNKNOWN

Sponsor Role: collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jack Stevens

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jack Stevens, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

IRB11-00719

Identifier Type: -

Identifier Source: org_study_id