Clinical trial NCT02996175: Treatment of Sleep Disturbances in School-age Children With Down Syndrome
Official title: Treatment of Sleep Disturbances in School-age Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Behavior
Sleep
Problems
Intervention
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Longer child sleep duration as measured by actigraphy and Improved sleep quality for child measure by Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: Baseline, 6 Weeks, 19 Weeks
Secondary outcomes:
measure: Improved child behaviors as measured by parent report on Child Behavior Checklist (CBCL)
timeFrame: Baseline, 6 Weeks, 19 Weeks
measure: Longer Parent sleep duration as measured by actigraphy and reduced parental stress as measured by the Family Impact Questionnaire (FIQ).
timeFrame: Baseline, 6 Weeks, 19 Weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References: