Down Syndrome Clinical Trial
Official title:
Treatment of Sleep Disturbances in School-age Children With Down Syndrome
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.
The investigators long-term goal is to improve outcomes for children with 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 catered to the unique needs of children with DS,
adapting an intervention developed by a member of the investigators research team with NIH
support (R34 MH082882) that successfully treats behavioral sleep disturbances in children
with autism41. 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. As a
critical first step towards an effective treatment, this initial efficacy study will address
3 aims:
Aim #1: Test the efficacy of manualized BST for improving the sleep of children with DS.
Hypothesis 1: Sleep duration and quality will improve more in the BST condition than the CON
condition.
Aim #2: Test the impact of the BST on the daytime functioning of children with DS.
Hypothesis 2: Children receiving BST will make greater gains in inhibitory control, general
behavior problems and other measures of executive dysfunction than in the CON condition.
Aim #3: Test whether the BST, which focuses on the child's sleep, also impacts caregivers'
sleep and stress.
Hypothesis 3: Parents of children receiving BST will have improved sleep duration and
decreased stress.
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