Treatment of Sleep Disturbances in School-age Children With Down Syndrome

Completed · Not applicable

Conditions studied: Down Syndrome

In brief

The investigators long-term goal is to improve outcomes for children with Down syndrome (DS) and their caregivers. Towards that goal, the investigators propose a randomized clinical trial of a behavioral sleep treatment designed specifically for children with DS, documenting the impact not only on sleep, but also on the child's daytime inhibitory control and behavior problems, and the caregiver's sleep and stress levels. The investigators will randomize 80 families of children with DS ages 6-17 to receive either a 5-session behavioral sleep treatment (BST; targeting sleep education, behavioral principles and visual supports) or a general-education control condition (CON). The BST will cater to the unique needs of children with DS, adapting an intervention that successfully treats behavioral sleep disturbances in children with autism1. Pre- and post-intervention, children will undergo comprehensive assessments of cognitive, behavioral, and adaptive functioning involving direct testing and input from parents and teachers. Child and parent sleep will be monitored via actigraphy and parent-completed sleep diaries, and parents will report on their stress levels and mood.

Key facts

Study ID

NCT02996175

Run by

Children's Hospital Medical Center, Cincinnati

People needed

34

Starts

2015-07-01

Expected to finish

2018-05-01

Last updated by the study team

2018-06-04

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• diagnosis of Down Syndrome
• 6-17 years of age
• behavioral sleep problem (presence of 5 or more nights a week of: bedtime resistance, delayed sleep onset, problematic sleep associations, nighttime awakenings or morning awakenings)
• English as primary language

You may not qualify if…

• past diagnosis of Pervasive Developmental Disorder-Not Otherwise Specified/Autism Spectrum Disorder
• History of blindness,deafness,motor impairment
• nonverbal mental age below 36 months
• any medication change w/in past 2 months affecting sleep

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.