Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial

Launched by NATIONAL CANCER INSTITUTE (NCI) · May 4, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at whether Acceptance and Commitment Therapy (ACT) can help caregivers of children with RASopathies, which are genetic conditions that can affect a child's development and lead to various challenges. The main goal is to see if this therapy can reduce the stress that caregivers experience while raising their children. If you are at least 18 years old, are a parent or legal guardian of a child under 18 with one of these conditions, and feel a moderate level of parenting stress, you may be eligible to participate.

The study is conducted entirely online, so you will need a mobile device with internet access. Participants will watch videos and complete surveys about their experiences with parenting stress, life satisfaction, and their ability to handle difficult feelings. The program lasts for eight weeks and includes coaching sessions to help caregivers learn and practice ACT techniques. If you decide to join, you’ll be part of a supportive community working to improve your well-being while caring for your child.

Gender

ALL

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