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.