Project WellCAST: Caregivers of Children with Fragile X Needed for a Research Study

The Kelleher Lab at Purdue University is conducting a clinical trial to learn more about helping families of children with rare disorders access evidence-based support from home.

We know that caregivers of children with neurogenetic syndromes are under a lot of stress, and sometimes it can be hard to find providers who know about your loved one’s condition. We know it can be difficult to have to explain life as a caregiver to people who haven’t engaged with the Fragile X community before. We know that it can be hard to fit support into your busy schedule and life.

The Kelleher lab’s goal is to understand how to best support caregivers of individuals with rare disorders in their day-to-day lives. To do this, they are conducting a research study to evaluate different support programs with rare disorder caregivers across the country.

About the Study

Who can participate?

Caregivers of children (aged 2-35) with Fragile X syndrome (FXS) and other neurogenetic conditions may be eligible to participate. Caregivers must reside in the United States and be the legal guardian of their child with FXS.

What will happen in the study?

If the individual qualifies and decides to be in this research study, they will provide some data about their experiences and feelings across a two-week period, using both self-report questionnaires, as well as “snapshot surveys” that are sent to their phone three times per day. Next, caregivers will be assigned to a support program, which may include self-directed resources, therapy focused on their mental health, parent coaching focused on their child’s challenging behaviors, and/or peer coaching by other rare disorder caregivers. Study activities span approximately 6.5 months, although there is “down time” between each phase of the project.

The following is a list of some of the study procedures that will happen during the study:

• Study Forms – At 5 different points, we will ask participants to complete forms that help us learn about their experiences and feelings.
• Daily Snapshot Surveys – During three portions of the project, we will send caregivers short “snapshot surveys” to their smartphones three times per day. Each survey takes less than 3 minutes to complete. Caregivers complete these surveys across 16 weeks total.
• Caregivers Support Program – Caregivers will be assigned to a caregiver support program, as described above. Because this is a research study, caregivers cannot choose which program they complete. However, we will ask you a few questions about your preferences prior to assigning your program.

Participants will be completing all of these procedures from home, and no travel is required. All materials will be provided free of charge. Support programs are delivered via telehealth, and forms are online and can be completed from your smartphone/computer.

What are the good things that can happen from this research?

Participants in this study are helping generate knowledge that will improve support options for rare disorder caregivers, while also receiving support themselves.

What are the bad things that can happen from this research?

Any clinical trial comes with some risks. The risks for Project WellCAST vary depending on the type of support you receive, and these risks will be clearly shared with you prior to you providing consent to participate in your assigned support activities.

Participating in support programs and answering questions about their mood and well-being can bring up challenging emotions and feelings. Caregivers attempting to change how they engage with their child may also experience frustration, including from their child.

Any research study also includes risks related to technology and data, including breaches in confidentiality. Again, these risks will be clearly shared with you as part of the informed consent process. Please know that we take your confidentiality very seriously. All of your study data are labeled with a numeric ID rather than your name, we store and transfer all data using secure software programs and platforms, and we train all project staff to uphold rigorous data protection standards. If you participate in a group- or peer-to-peer support option, all participants will also receive training on confidentiality and respecting each other’s privacy. These risks and how we protect you from risk will be talked about further as part of the consent process.

There may be other risks that we do not know about yet.

Will I or my child be paid to complete this study?

Participants can also receive up to $100 based on completion of forms. Any resources or therapy you receive are provided free of charge.

Interested in Participating?