Improving sleep quality in individuals with Down syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to adapt a virtual Mindfulness-Based Therapy for Insomnia (MBTI) specifically for individuals with Down syndrome aged 12-30 years. The intervention will be developed in collaboration with a community advisory board, ensuring it is relevant and engaging for participants. Key adaptations include the use of visual aids, shortened meditation practices, caregiver involvement, and modified session structures to enhance participation and effectiveness. The goal is to improve sleep quality and overall quality of life for both individuals with Down syndrome and their caregivers.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Caroline G Richter, PhD — University of Alabama at Birmingham
• Study coordinator: Caroline G Richter, PhD
• Email: carolinerichter@uab.edu
• Phone: 205-934-9897

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.