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

NCT01558180 | Completed Phase 2

• 1 other identifier: IRB11-00719
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Autism Spectrum Disorders; Insomnia

Outcome Measures

Primary Outcomes (1)

• Children's Sleep Habits Questionnaire

  2 month follow-up

Secondary Outcomes (1)

• Actigraphy (Activity Monitoring)

  2 month follow up

Study Arms (2)

Telephone Care Management

EXPERIMENTAL

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

Behavioral: Telephone Care Management

Usual Care

PLACEBO COMPARATOR

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.

Behavioral: Usual Care

Interventions

Telephone Care Management BEHAVIORAL

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

Also known as: TCM

Telephone Care Management

Usual Care BEHAVIORAL

educational handouts on pediatric insomnia

Also known as: UC

Usual Care

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Insomnia
• Autism Spectrum Disorder
• Regular telephone service for caregiver
• Stable dose of medication

You may not qualify if:

• Signs of obstructive sleep apnea (e.g., turning blue or stop breathing at night, recurrent snoring)
• Receptive language skills under 18 months

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• The Ingram Foundation is funding this work.: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jack Stevens, Ph.D.

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 20, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 3, 2015

Record last verified: 2015-02

Locations

US (1)