Sleep Intervention and Quality of Life in Down Syndrome

NCT06783725 | Recruiting

• 2 other identifiers: IRB-3000133313128827.000.213128827.48160000
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Down Syndrome; Down Syndrome (Trisomy 21)

Keywords

Down syndrome; sleep; Mindfulness-Based Therapy for Insomnia

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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)

  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

  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.

  Before (week 0) and at week 9 (the end of the 8-week intervention period).

Secondary Outcomes (3)

• Quality of life - Caregiver report

  Before (week 0) and at week 9 (the end of the 8-week intervention period).

• Quality of life

  Before (week 0) and at week 9 (the end of the 8-week intervention period).

• Quality of life

  Before (week 0) and at week 9 (the end of the 8-week intervention period).

Study Arms (2)

Mindfulness-Based Therapy for Insomnia

EXPERIMENTAL

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

Wait-list control

PLACEBO COMPARATOR

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

Interventions

Mindfulness-Based Therapy for Insomnia BEHAVIORAL

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.

Mindfulness-Based Therapy for Insomnia

Wait-list control BEHAVIORAL

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.

Wait-list control

Eligibility Criteria

• Age: 12 Months - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Caroline G Richter, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline G Richter, PhD

CONTACT

205-934-9897; carolinerichter@uab.edu

Sylvie Mrug, PhD

CONTACT

(205) 934-3850; sylva@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 20, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)