Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial
Neurofibromatosis 1, Noonan Syndrome, Legius Syndrome
About this trial
This is an interventional supportive care trial for Neurofibromatosis 1 focused on measuring Parenting, Stress, Parent, Therapist, Coach, virtual, Quality of Life, Genetic Condition, Rare
Eligibility Criteria
- 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
- Began taking psychiatric medication, including but not limited to an anti-depressant, fewer than 4 weeks from the day of enrollment
Sites / Locations
- National Cancer Institute (NCI)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
1/Internal Pilot
2/Immediate Intervention
3/Waitlist Control
Participants will begin their 1-week baseline EMA data collection period and then take part in intervention procedures immediately after enrollment to assess feasibility and acceptability.
Participants will begin their 1-week baseline EMA data collection period immediately after randomization and will begin receiving the 8-week intervention at the end of this week/beginning of the next week (depending on participant schedule).
After an initial 1-week baseline period for EMA data collection and 8 weeks of maintaining their usual routine (wait list period), participants will begin receiving the 8-week intervention.