Actively Recruiting
Sleep Intervention and Quality of Life in Down Syndrome
Led by University of Alabama at Birmingham · Updated on 2026-03-20
20
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Aim 1 of the proposed project will be to adapt the virtual Mindfulness-Based Therapy for Insomnia (MBTI) for individuals with Down syndrome (DS). The investigators will work closely with a community advisory board consisting of individuals with DS, their caregivers, and clinicians specializing in DS and sleep medicine to ensure that the intervention protocol is relevant and appropriate for young people with DS (age 12 and older). Planned adaptations include 1) utilization of visual aids and videos to increase engagement and reinforce mindfulness concepts and practices; 2) shortened meditation practices to accommodate concentration limits of individuals with DS; 3) caregiver involvement reflecting the important role of caregivers in daily functioning of individuals with DS; 4) adapted homework to cater to the learning styles of individuals with DS; 5) daily reminders to encourage regular practice and reinforce the importance of consistency; and 6) modified session structure to ensure that participants are able to discuss their experiences and refine their mindfulness practice. During the first 6 months of the project, the investigators will meet monthly with the community advisory board and use an iterative process to develop detailed intervention protocol for a virtual MBTI suitable for young people with DS. Aim 2 of the project will be to pilot test the efficacy of the virtual MBTI for young people with DS. In the second half of the one-year project, the investigators will conduct a pilot randomized clinical trial (RCT) of the intervention developed in Aim 1. This project will compare the effectiveness of Mindfulness Based Therapy for Insomnia (MBTI) and Brief Behavioral Therapy for Insomnia (BBTI) for young people with Down syndrome (DS). The interventions will be compared on their impact on improving sleep problems, quality of life, and functional outcomes. This project will also test if targeting the sleep of the caregiver in addition to the individual with Down syndrome has any effect on the outcomes.
CONDITIONS
Official Title
Sleep Intervention and Quality of Life in Down Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals with a confirmed diagnosis of Down syndrome (DS)
- English is the primary language spoken in the household
- Nonverbal mental age of at least 36 months, based on adaptive skills assessment
- Presence of at least one sleep disturbance occurring five or more nights per week, such as bedtime resistance, delayed sleep onset, problematic sleep associations, nighttime awakenings, or early morning awakenings
You will not qualify if you...
- Severe sensory or motor impairments that interfere with participation in the intervention
- Inability to complete assessments or participate in intervention sessions due to behavioral or medical conditions
- Participation in other behavioral or sleep interventions during the study
- Caregiver inability or unwillingness to provide accurate reports or assist with intervention activities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
C
Caroline G Richter, PhD
CONTACT
S
Sylvie Mrug, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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