An interventional study of Mindfulness-Based Therapy for Insomnia and Wait-list control in Down Syndrome and Down Syndrome (Trisomy 21), sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 12 Months to 30 Years. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
This study aims to address the significant gap in effective behavioral treatments for sleep problems in individuals with Down syndrome (DS). Specifically, it focuses on testing the efficacy of a virtual Mindfulness-Based Therapy for Insomnia (MBTI) for individuals with DS aged 12-30 years, along with their caregivers. The intervention seeks to improve sleep quality and overall quality of life for both participants and their caregivers.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
This study's planned enrollment of 20 is below the median of 37 across 286 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
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Exclusion Criteria:
Individuals with Down syndrome will receive the MBTI intervention over 8 sessions lasting 1 hour over 8 weeks (one session per week). One trained graduate research assistant will deliver the intervention with supervision of a licensed Clinical Psychologist.
Behavioral: Mindfulness-Based Therapy for Insomnia
The control group will do the pre and post assessments but will not be part of any intervention. The wait-list control group will receive the MBTI intervention after the post-intervention measures are completed.
Behavioral: Wait-list control
Mindfulness-based therapy for insomnia (MBTI) is a structured program designed to help individuals with chronic insomnia improve their sleep patterns through mindfulness practices. It combines mindfulness meditation, cognitive behavioral strategies, and sleep education to address the cognitive and physiological factors that disrupt sleep. The therapy emphasizes present-moment awareness, acceptance of sleep difficulties, and the reduction of sleep-related anxiety to promote better sleep quality and overall well-being.
The wait-list control group consists of participants who do not receive the intervention during the initial study period but are placed on a waitlist to receive it after the trial concludes. This group serves as a comparison to evaluate the effectiveness of the intervention while ensuring participants eventually have access to the treatment. It helps control for natural changes over time and the psychological effects of expecting future treatment.
Objective Sleep Quality - Sleep duration
Assessed using wearable devices (FitBit Versa 4), which record sleep parameters: Sleep duration (in hours). Sleep duration in hours will be averaged over seven consecutive days, before and after the 8-week intervention. Higher scores indicate better outcome.
Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Objective Sleep Quality - Sleep efficiency
Assessed using wearable devices (FitBit Versa 4), which record sleep parameters: Sleep efficiency (percentage of time spent asleep while in bed). Higher scores indicate better outcome.
Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Objective Sleep Quality - Number of night awakenings
Assessed using wearable devices (FitBit Versa 4), which record sleep parameters: Number of night awakenings (count for night awakenings)
Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Subjective Sleep Quality - Children's Sleep Habits Questionnaire
Measured using standardized parent-reported questionnaires: \- Children's Sleep Habits Questionnaire (CSHQ): Assesses sleep behaviors and patterns. The CSHQ is a retrospective, 45-item parent questionnaire. Scale Range: 45-135. Higher scores indicate worse sleep quality. Unit of Measure: Raw score
Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Subjective Sleep Quality - Insomnia Severity Index
\- Insomnia Severity Index (ISI): Measures the severity of insomnia symptoms. Scale Range: 0-28. Higher scores indicate worse insomnia severity.
Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Quality of life - Caregiver report
Quality of life is a secondary outcome variable, evaluated using caregiver-reported measures: 1) Pediatric Quality of Life Inventory (PedsQL): Assesses health-related quality of life across physical, emotional, social, and school functioning domains. Scale Range: 0-100. Higher scores indicate better quality of life. Changes in scores before and after the intervention will be compared to evaluate improvements in quality of life.
Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Quality of life
Quality of life is a secondary outcome variable, evaluated using caregiver-reported measures: 2\) KidsLife: Measures quality of life specific to individuals with developmental disabilities, including participation and independence. Scale Range: 0-100. Higher scores indicate better quality of life.
Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Quality of life
Quality of life is a secondary outcome variable, evaluated using caregiver-reported measures: 3\) KIDSCREEN-27: Evaluates physical well-being, psychological well-being, autonomy, social support, and peer relationships. Scale Range: 0-100. Higher scores indicate better quality of life.
Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Plan to share: No
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Started Mar 2025 (actual). Primary completion is estimated for Dec 2027, 33 months after the start.
Of 163 non-industry interventional studies with no phase under Down Syndrome, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 35. This study's planned 33 months is above that.
Counting every sponsor, half of 165 studies reached it within 11 months; a quarter within 3 and three quarters within 35.
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University of Alabama at Birmingham →