Sleep Intervention in Young Boys with Duchenne Muscular Dystrophy

NCT04529707 | Completed

• 1 other identifier: STUDY20030019
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Duchenne Muscular Dystrophy

Keywords

Duchenne Muscular Dystrophy; Sleep; Intervention

Outcome Measures

Primary Outcomes (1)

• Parent Mastery Questionnaire

  100% of parents who are retained throughout the study will attain ≥80% knowledge accuracy at each knowledge check time point and will accurately answer 8 of the 10 questions provided.

  A 10-item questionnaire focused on intervention modules will be delivered every 2-3 weeks during the 10 week intervention. Parents will be required to answer questions that address their knowledge of the information provided in each module.

Secondary Outcomes (2)

• Child intradaily variability from Actigraphy

  2 weeks pre-intervention and 2 weeks post-intervention

• Child relative amplitude from Actigraph

  2 weeks pre-intervention and 2 weeks post-intervention.

Study Arms (1)

Sleep Intervention

EXPERIMENTAL

All participants will engage in a 10-week, parent mediated sleep intervention with weekly education sessions.

Behavioral: Transdiagnostic Behavioral Sleep Intervention

Interventions

Transdiagnostic Behavioral Sleep Intervention BEHAVIORAL

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.

Sleep Intervention

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Parents/caregivers of youth between ages 6 and 17 with a primary diagnosis of Duchenne muscular dystrophy (DMD) who lives at home .
• Access to a smart-phone or computer and internet for the weekly web-based sessions, as well as uploading of the Actigraph data;
• English speaking.

You may not qualify if:

• Unable to speak or read English
• Their child with DMD has cognitive or behavioral concerns that would limit participation and follow-through of intervention;
• Their child/youth with DMD is currently receiving an intervention for a sleep related disorder

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Angela Caldwell, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The overall objective of this project is to conduct an early phase single-group repeated measures design project examining the implementation and within-subjects effects of a 10-week parent-mediated TranS-CY program to improve sleep health in young boys with DMD.

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 28, 2020
• Study Start: February 17, 2021
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and additional supporting information will be made available approximately 3 months after summary data are published or otherwise disseminated.
• Access Criteria: IPD will be shared with researchers within and outside of the University of Pittsburgh through email requests to the lead principal investigator. The University of Pittsburgh may require a data use agreement be developed and signed by both institutions. The full study protocol and informed consent forms will be shared. Only aggregate and de-identified data collected throughout the clinical trial will be shared.

Locations

US (1)