NCT04529707

Sleep Intervention in Young Boys with Duchenne Muscular Dystrophy

Sleep Health Dysfunction and the Use of a Transdiagnostic Sleep Intervention in Duchenne Muscular Dystrophy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This project will systematically plan and evaluate the implementation of the Transdiagnostic Sleep and Circadian Intervention for youth (TranS-CY). As an early stage study, investigators will focus on recruitment strategies to reach the target population and collection of preliminary data on primary and secondary effects of the TranS-CY. Weekly remote (video web conferencing) parent training sessions will allow investigators to explore adoption through parent adherence and examine whether the essential elements of the TranS-CY intervention (e.g., motivational interviewing, goal setting, problem solving, sleep routine scheduling, monitoring) can be consistently taught by clinicians and implemented by parents into the home setting.

Detailed description

Pre-phase (2 weeks in duration): Initial Interview: Following informed consent and enrollment, participants will complete a 45-60 minute interview with research investigators using video web conferencing (e.g., Zoom). If the participant agrees, this interview will be recorded. During this interview, investigators will gather descriptive data to characterize the sample including information regarding: 1) the child (age, disease severity for DMD, weight/ height, race/ethnicity, location (rural/suburban/urban), grade in school, medication use); 2) the parent (race/ethnicity, marital status, work status, education level, income); 3) the child's sleep environment (technology/telephone access, darkness, temperature, bed/bedroom sharing); 4) the child's daily activities and routines (current wake-up time \& routines; activities in the home; activities at school and after school); and 5) the child's nighttime routines (activities prior to bedtime; current bedtime routine; technology use prior to bedtime). ActiGraph: Each parent-child dyad will be mailed a package containing the Actigraph GT9x with wristband, charging device, a manual of operating procedures (MOP) providing all technical and protocol instructions, and phone numbers for research team support. Throughout the 2-week pre-phase data collection period, parents will be required to log and push data from their child's Actigraph to a secure cloud service, CentrePoint, via Wi-Fi each day. This will be accomplished through an app and all data will be de-identified. Intervention Implementation Phase (10-week duration): Training Modules: During the intervention phase, weekly video-conference meetings will be held where trained clinicians will guide parents through approximately 60-minute web-based modules using a video-conferencing platform (e.g., Zoom). These sessions will focus on education, dynamic parent training (child-related goal-setting and problem-solving), assessment of sleep health dimensions, and development of a weekly sleep and activity diary. Parents will be provided with a personalized TranS-CY Parent Workbook, which contains information regarding each of the 10 weekly modules. Each weekly session will be agenda driven with the option to revise the agenda based on family needs. Children/youth with DMD will be invited to attend the sessions and provide as much feedback as possible. Data will be collected on parent attendance to assess intervention adoption. Each week, clinicians will request feedback on the previous week's session and provide additional educational support for the previous content should it be required. Intervention Questionnaires: During the 10-week intervention phase, parents will be asked to complete knowledge checks every 2-3 weeks in order to confirm understanding of the module information (primary outcome). These questionnaires will either be asked verbally during the session or questions will be sent to the parent's email through Qualtrics, a HIPAA compliant survey software platform. Hard copies of the knowledge checks will be sent if the parent prefers. Sleep and Activity Log: Throughout the intervention phase, parents will be asked to complete a daily sleep and activity log covering their child's day. This log will be sent to their emails using Qualtrics. Each log will take approximately 3-5 minutes to complete. Post-Intervention Phase (2 weeks): ActiGraph: At the end of the 10-week intervention, each participant (parent-child dyad) will again be mailed an Actigraph GT9x, all accessories and protocols. Throughout the 2-week post-phase data collection period, parents will again use their personal smart-phone app to log and push data from the Actigraph to CentrePoint, via Wi-Fi each day. Data from the Actigraph GT9x will be provide the secondary outcome of percent sleep efficiency. Investigators will explore change in percent sleep efficiency at pre-post 10 week TranS-CY intervention.

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
BEHAVIORAL	Transdiagnostic Behavioral Sleep Intervention	The Transdiagnostic Sleep and Circadian Intervention for Youth (TranS-CY) uses a comprehensive sleep health framework along with robust evidence for promoting healthy sleep patterns in youth. The TranS-CY incorporates best practices from numerous efficacious behavioral sleep interventions including 1) cognitive behavioral therapy, 2) interpersonal and social rhythm therapy, and 3) behavioral treatment of circadian rhythm sleep-wake disorders. The "traditional" TranS-CY is clinician-led and provides a robust sleep treatment framework for youth with a wide range of disorders and sleep health concerns. For this study, investigators are using the basic framework of the TranS-CY, but clinicians will train parents to incorporate the intervention into the home for their young child with DMD. Trained clinicians will work with parents to ensure the basic components of the TranS-CY are incorporated into the home-based intervention.

Timeline

• Start date: 2021-02-17
• Primary completion: 2024-10-31
• Completion: 2024-12-31
• First posted: 2020-08-28
• Last updated: 2025-03-07

Locations

1 site across 1 country: United States