Adapting a Psychosocial Support Intervention for the Rett Syndrome Community

ConditionsRett Syndrome Family Caregivers Social Support Psychological Support

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorColorado State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Those who have patients prescribed Daybue
Other intervention
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 intervention
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Pharmacologic Treatment OnlyActive comparator 1 intervention

Group B: Pharmacologic Treatment Plus Caregiver Speaks-RTTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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).

Time frame

Immediately post-intervention (6 weeks)

Secondary outcomes

Acceptability of Intervention Measure (AIM)

Caregiver-reported acceptability and perceived appropriateness of the Caregiver Speaks-RTT psychosocial intervention, assessed using the Acceptability of Intervention Measure (AIM). Measures assess satisfaction with intervention content, delivery format, relevance to caregiving for individuals with Rett syndrome, and perceived fit within caregivers' needs. 1 to 5 (average score across 4 items; alternatively 4 to 20 if summed).

Time frame

Immediately post-intervention (6 weeks)

Intervention Appropriateness Measure (IAM)

Caregiver-reported perceived appropriateness of the Caregiver Speaks-RTT intervention, assessed using the Intervention Appropriateness Measure (IAM). This measure evaluates perceived fit, relevance, and suitability of the intervention for caregivers of individuals with Rett syndrome. 1 to 5 (average score across 4 items; alternatively 4 to 20 if summed).

Time frame

Immediately post-intervention (6 weeks).

Other outcomes

Interviews to Qualitatively Assess Acceptability and Implementation Feedback

Qualitative assessment of caregiver experiences with Caregiver Speaks-RTT obtained through semi-structured post-intervention interviews. Interviews explore perceived benefits, challenges, barriers and facilitators to participation, and suggestions for intervention refinement and clinical integration.

Time frame

Immediately post-intervention (6-weeks).

Intervention Engagement and Participation

Intervention engagement assessed by session participation metrics, including proportion of weekly prompts responded to and overall participation across the 6-week intervention period. Engagement thresholds are used to support feasibility and acceptability assessments.

Time frame

Weekly during the 6-week intervention period.

Parenting Stress Index-Short Form

Caregiver-reported stress and caregiving burden assessed using the Parenting Stress Index-Short Form and the RTT Caregiver Inventory to explore changes associated with pharmacologic treatment alone versus pharmacologic treatment plus Caregiver Speaks-RTT. Minimum score is 36 to maximum 180. Higher scores indicate greater parenting stress (worse outcome). The PSI-SF contains 36 items scored 1-5.

Time frame

Baseline and post-intervention (6 weeks)

Medication Adherence and Barriers

Caregiver-reported barriers and facilitators to medication adherence assessed using the Parent Medication Barriers Scale and qualitative interview questions to contextualize pharmacologic treatment experiences.

Time frame

Baseline and post-intervention (6 weeks)

Sponsors and contacts

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Colorado State University

Lead sponsor

University of Denver

Collaborator

Children's Hospital Colorado

Collaborator

Source ClinicalTrials.gov

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