Status:
RECRUITING
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Neurofibromatosis 1
Noonan Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: RASopathies are a group of genetic diseases that affect a child s development. They cause physical, cognitive, and behavioral symptoms. Caring for a child with a RASopathy can be stressfu...
Detailed Description
Background: * RASopathies are a group of neurodevelopmental genetic conditions caused by mutations affecting components within the RAS-map kinase (RAS-MAPK) cellular signaling pathway. * Caregivers o...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Ability to understand and the willingness to sign a written informed consent document
- Ability to read and speak English
- Age \>= 18 years
- Caregiver (defined as parent or legal guardian) of a child (\< 18 years) with a diagnosis of a RASopathy syndrome including NF1, Noonan Syndrome, Legius Syndrome, CFC, and Costello Syndrome, or another RASopathy
- The participant s child with a RASopathy must live with them at least 50% of the time
- Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access) or be willing to use an iPod provided by study team.
- Must score a 15 or higher total score on modified questions from the Parental Stress Scale (PSS), indicating endorsement of the midpoint response on average and thus a moderate level of parenting stress.
- Caregiver must not be participating in or planning to participate in psychosocial intervention primarily targeting parenting stress over the duration of the study. Caregivers are able to receive interventions for other mental health concerns as long as parenting stress is not the main focus of treatment.
- EXCLUSION CRITERIA:
- Another caregiver in the same household is participating in this protocol. If two caregivers in the same household want to participate, we will inform them that one can enroll on the protocol and the other can receive the intervention materials (e.g., parent workbook, audio recordings) to practice on their own. The reason for this is that parents participating with their partner may interact with the intervention differently and have more direct support than other participants. We will collect data on how many caregivers live in the household and how often the second parent engaged with the parent workbook and audio recordings in our pre and post study questionnaires.
- Uncontrolled psychiatric illness, cognitive impairments, or other circumstance as judged by the Principal Investigator, a licensed psychologist, that would limit compliance with study requirements
Exclusion
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05361811
Start Date
January 10 2024
End Date
December 31 2025
Last Update
July 3 2025
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892