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Trial · Interventional

Not yet recruitingNot applicableRegistry data

Adapting a Psychosocial Support Intervention for the Rett Syndrome Community

NCTNCT07730112 (opens ClinicalTrials.gov in a new tab)Other id7932Other idIIS-RS-2025-006
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Not applicable
Enrollment
60 participants (estimated)
Sponsor
Colorado State University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
1 Aug 2026 (estimated)
Primary completion
31 May 2028 (estimated)
Completion
31 May 2028 (estimated)
First posted
28 Jul 2026
Last update posted
28 Jul 2026
Conditions
Rett Syndrome · Family Caregivers · Social Support · Psychological Support

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. N/A

    Adapting a Psychosocial Support Intervention for the Rett Syndrome Community

    NCT07730112

    est. 1 Aug 2026 to est. 31 May 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Those who have patients prescribed DaybueOther
  • Caregiver Speaks + DaybueOther

Arms2

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. Feasibility of Intervention Measure (FIM)

    Time frame · Immediately post-intervention (6 weeks)

    Registry description

    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).

Secondary outcomes(2)

  1. Acceptability of Intervention Measure (AIM)

    Time frame · Immediately post-intervention (6 weeks)

    Registry description

    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).

  2. Intervention Appropriateness Measure (IAM)

    Time frame · Immediately post-intervention (6 weeks).

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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).

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