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Adapting a Psychosocial Support Intervention for the Rett Syndrome Community

NCT07730112 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-28

No results posted yet for this study

Summary

This study seeks to adapt Caregiver Speaks, a psychosocial supportive intervention delivered through Facebook, for parent caregivers of children living with Rett Syndrome. This study also seeks to explore feasibility and acceptability of implementing the adapted intervention, and its impact on parent psychological outcomes.

Conditions

  • Rett Syndrome
  • Family Caregivers
  • Social Support
  • Psychological Support

Interventions

OTHER

Those who have patients prescribed Daybue

Participants must be receiving Daybue (trofinetide) as prescribed and managed by their treating clinician as part of routine clinical care. The study does not assign, initiate, modify, or manage pharmacologic treatment. Participants are required to continue taking Daybue according to their physician's prescription during the study period. Medication dosing, monitoring, and clinical decision-making remain entirely under the care of the participant's healthcare provider.

OTHER

Caregiver Speaks + Daybue

Participants receive standard pharmacologic treatment for Rett syndrome (e.g., Daybue \[trofinetide\]) as prescribed and managed by their clinical care team. Medication use follows routine clinical practice, including dosing, monitoring, and management of side effects. No experimental medication dosing or alteration is required as part of this study. Pharmacologic treatment is provided either alone or in combination with the Caregiver Speaks-RTT psychosocial intervention, depending on randomized group assignment.

Sponsors & Collaborators

  • University of Denver

    collaborator OTHER

  • Children's Hospital Colorado

    collaborator OTHER

  • Colorado State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07730112 on ClinicalTrials.gov