Treatment of Sleep Disturbances in School-age Children With Down Syndrome
Status: | Completed |
---|---|
Conditions: | Other Indications |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 6 - 17 |
Updated: | 6/6/2018 |
Start Date: | July 2015 |
End Date: | May 2018 |
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Phone: 513-803-3641
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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