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

NCT01558180 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-02-03

No results posted yet for this study

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).

Conditions

Interventions

BEHAVIORAL

Telephone Care Management

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

BEHAVIORAL

Usual Care

educational handouts on pediatric insomnia

Sponsors & Collaborators

  • The Ingram Foundation is funding this work.

    collaborator UNKNOWN

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Jack Stevens, Ph.D. · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01558180 on ClinicalTrials.gov