Sleep Intervention and Quality of Life in Down Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-30
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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, as determined by a baseline measure of adaptive skills.
Presence of at least one sleep disturbance occurring five or more nights per week, as reported by a caregiver. Sleep disturbances may include: Bedtime resistance; Delayed sleep onset; Problematic sleep associations; Nighttime awakenings; Early morning awakenings
Disqualifiers
Severe sensory or motor impairments that would interfere with participation in the intervention.
Inability to complete assessments or participate in the intervention sessions due to behavioral or medical conditions.
Participation in other concurrent behavioral or sleep interventions.
Caregiver inability or unwillingness to provide accurate reports or assist in intervention activities as needed.
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness-Based Therapy for Insomnia
BehavioralMindfulness-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.
Wait-list control
BehavioralThe 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Mindfulness-Based Therapy for InsomniaExperimental treatment 1 intervention
Group B: Wait-list controlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).2
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).3
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).4
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).Secondary outcomes
1
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).2
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).3
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).Sponsors and contacts
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Source ClinicalTrials.gov