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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01558180
Enrollment
60
Registered
2012-03-20
Start date
2012-04-30
Completion date
2013-12-31
Last updated
2015-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorders, Insomnia

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.

Interventions

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

BEHAVIORALUsual Care

educational handouts on pediatric insomnia

Sponsors

The Ingram Foundation is funding this work.
CollaboratorUNKNOWN
Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Children's Sleep Habits Questionnaire2 month follow-up

Secondary

MeasureTime frame
Actigraphy (Activity Monitoring)2 month follow up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026