Recruiting

Sleep Intervention

Sponsor:

University of Alabama at Birmingham

Code:

NCT06783725

Conditions

Down Syndrome

Down Syndrome (Trisomy 21)

Eligibility Criteria

Sex: All

Age: 1 - 30

Healthy Volunteers: Not accepted

Interventions

Mindfulness-Based Therapy for Insomnia

Wait-list control

Study Details

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)

Study ID

NCT06783725

Start date

Mar 1, 2025

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mindfulness-Based Therapy for Insomnia

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.

placebo comparator: Wait-list control

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.

Interventions

Mindfulness-Based Therapy for Insomnia

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.

Wait-list control

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.

Primary outcome measure

  • Objective Sleep Quality - Sleep duration [ Time Frame: Before (week 0) and at week 9 (the end of the 8-week intervention period). ]
  • Objective Sleep Quality - Sleep efficiency [ Time Frame: Before (week 0) and at week 9 (the end of the 8-week intervention period). ]
  • Objective Sleep Quality - Number of 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 [ Time Frame: Before (week 0) and at week 9 (the end of the 8-week intervention period). ]
  • Subjective Sleep Quality - Insomnia Severity Index [ Time Frame: Before (week 0) and at week 9 (the end of the 8-week intervention period). ]

Central Contacts and Locations

Central contacts

Caroline G Richter, PhD

205-934-9897carolinerichter@uab.edu

Sylvie Mrug, PhD

(205) 934-3850sylva@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Caroline G Richter, PhD

205-934-9897carolinerichter@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • Down syndrome
  • sleep
  • Mindfulness-Based Therapy for Insomnia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-03-20.