Adapting a Psychosocial Support Intervention for the Rett Syndrome Community

NCT07730112 | Not Yet Recruiting

• 2 other identifiers: 7932IIS-RS-2025-006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Family Caregivers; Rett Syndrome; Online Support Group; Meaning-making

Outcome Measures

Primary Outcomes (1)

• Feasibility of Intervention Measure (FIM)

  Feasibility of the Caregiver Speaks-RTT intervention assessed by caregiver recruitment, retention, session participation, and completeness of outcome data. Feasibility benchmarks include ≥80% intervention engagement, ≥80% retention through completion, and \<20% missing baseline or post-intervention data, measured using the Feasibility of Intervention Measure (FIM) and participation metrics. 1 to 5 (average score across 4 items; alternatively 4 to 20 if summed).

  Immediately post-intervention (6 weeks)

Secondary Outcomes (2)

• Acceptability of Intervention Measure (AIM)

  Immediately post-intervention (6 weeks)

• Intervention Appropriateness Measure (IAM)

  Immediately post-intervention (6 weeks).

Other Outcomes (9)

• Interviews to Qualitatively Assess Acceptability and Implementation Feedback

  Immediately post-intervention (6-weeks).

• Intervention Engagement and Participation

  Weekly during the 6-week intervention period.

• Parenting Stress Index-Short Form

  Baseline and post-intervention (6 weeks)

Study Arms (2)

Pharmacologic Treatment Only

ACTIVE COMPARATOR

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).

Other: Those who have patients prescribed Daybue

Pharmacologic Treatment Plus Caregiver Speaks-RTT

EXPERIMENTAL

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.

Other: Those who have patients prescribed Daybue; Other: Caregiver Speaks + Daybue

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.

Pharmacologic Treatment Only; Pharmacologic Treatment Plus Caregiver Speaks-RTT

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.

Pharmacologic Treatment Plus Caregiver Speaks-RTT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult caregiver (≥18 years old) of an individual with Rett syndrome Caregiver of a child or individual of any age with a confirmed clinical diagnosis of Rett syndrome.
• English-speaking and able to read and understand study materials Willing and able to participate in a 6-week, online psychosocial intervention delivered via a private social media platform
• Willing and able to complete electronic surveys and, if selected, participate in virtual interviews
• For randomized phase participation: child is receiving standard pharmacologic treatment for Rett syndrome (e.g., Daybue) as part of routine clinical care

You may not qualify if:

• Inability to speak, read, or understand English sufficiently to participate in the intervention and assessments.
• Caregiver under the age of 18 years
• Lack of confirmed diagnosis of Rett syndrome in the care recipient.
• Inability or unwillingness to provide informed consent.
• Lack of access to required technology (internet-enabled device and ability to access the online intervention platform).

Sponsors & Collaborators

• Colorado State University: lead
• University of Denver: collaborator
• Children's Hospital Colorado: collaborator

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

MeSH Terms

Conditions

Rett Syndrome

Interventions

trofinetide

Condition Hierarchy (Ancestors)

X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heredodegenerative Disorders, Nervous System

Central Study Contacts

Abigail Rolbiecki, PhD, MPH, MSW

CONTACT

970-491-6204; abigail.rolbiecki@colostate.edu

Talia Thompson, PhD

CONTACT

303-871-3736

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants, intervention facilitators, and clinical providers are not masked due to the nature of the psychosocial intervention. No additional parties beyond those listed are masked. Quantitative data analysis will be conducted using de-identified datasets, and qualitative analysts will not have access to randomization status during initial coding to minimize bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a multiphase interventional design. An initial single-arm pilot phase evaluates feasibility and acceptability of the Caregiver Speaks-RTT intervention using iterative refinement across cohorts. This is followed by an exploratory randomized parallel-group phase comparing pharmacologic treatment alone versus pharmacologic treatment combined with the Caregiver Speaks-RTT psychosocial intervention. Caregivers are assessed longitudinally with quantitative and qualitative outcomes.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: July 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified individual participant data (IPD) and supporting documentation will be available beginning after publication of the primary study results, anticipated within 12 months of study completion. Data will remain available for a minimum of 5 years following publication, subject to continued data stewardship and institutional policies.
• Access Criteria: De-identified IPD and supporting information will be available to qualified researchers for research purposes only. Data requests must include a brief proposal outlining the intended use of the data and must receive approval from the study investigators. Shared IPD will be limited to quantitative survey and assessment data; qualitative interview transcripts and audio recordings will not be shared due to the risk of participant re-identification. Access will be granted through secure data transfer following execution of an appropriate data use agreement and confirmation of ethical approvals where applicable.

Locations

US (1)