Adapting a Psychosocial Support Intervention for the Rett Syndrome Community

Part of paid clinical trials in Fort Collins, Colorado.

Sponsor
Colorado State University
Study ID
NCT07730112
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Those who have patients prescribed Daybue — OTHER
    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.
  • Caregiver Speaks + Daybue — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Pharmacologic Treatment Only
    Participants in this arm will receive standard pharmacologic treatment for Rett syndrome (e.g., Daybue) as prescribed by their clinical care team. Participants in this arm will not receive the Caregiver Speaks-RTT psychosocial intervention during the randomized study period but will be offered the opportunity to participate in the Caregiver Speaks-RTT intervention after completion of study follow-up assessments (wait-list control).
  • Experimental: Pharmacologic Treatment Plus Caregiver Speaks-RTT
    Participants in this arm will receive standard pharmacologic treatment for Rett syndrome (e.g., Daybue) in combination with the Caregiver Speaks-RTT psychosocial intervention, a 6-week, moderated, online, meaning-centered storytelling program designed to support caregiver wellbeing.

Primary Outcome Measure

Feasibility of Intervention Measure (FIM) [ Time Frame: Immediately post-intervention (6 weeks) ]

Central Contacts

  • Abigail Rolbiecki, PhD, MPH, MSW
    970-491-6204
    [email protected]
  • Talia Thompson, PhD
    303-871-3736

Locations (1)

FacilityCityStateZIPSite coordinators
Colorado State UniversityFort CollinsColorado80523
Abigail Rolbiecki, PhD, MPH, MSW
[email protected]
970-491-6204

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By research site
Colorado State University· Fort Collins, CO

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