Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy

This study is looking at whether Acceptance and Commitment Therapy (ACT) can help caregivers of children with a RASopathy (a group of genetic conditions like Neurofibromatosis 1 or Noonan Syndrome) cope with stress. Caring for a child with a RASopathy can be challenging, and ACT is a type of therapy that teaches mindfulness, acceptance of difficult thoughts, and acting on your values. The study aims to see if ACT is a practical and helpful intervention for these caregivers. You may be eligible if you are 18 or older, can read English, and are a parent or legal guardian of a child under 18 with a RASopathy who lives with you at least 50% of the time. The study plans to enroll 70 participants, but its current status is unclear.

Study design: This is an interventional study that will compare an 8-week ACT intervention to an 8-week waitlist period followed by the ACT intervention. It aims to enroll 70 participants.
What's involved: Participants will either receive an 8-week ACT intervention or maintain their usual routine for 8 weeks before starting the 8-week ACT intervention. The study is fully remote.
Compensation: Not stated in the trial record.
Follow-up: The study measures feasibility, acceptability, and changes in parenting stress at 9 weeks.

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

Recruiting

NAAges 18+InterventionalSupportive care

National Cancer Institute (NCI)

~70 participants

Updated 2026-08-24 on ClinicalTrials.gov

What's tested:WaitlistACT Intervention

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Feasibility & Acceptability

Measured over 9 weeks

+1 more outcome measured

Conditions

Neurofibromatosis 1

Noonan Syndrome

Legius Syndrome

Cardiofaciocutaneous Syndrome

Costello Syndrome

Where it's being run

1 sites across 1 states

Maryland1

Study leadership

Staci M Peron, Ph.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Staci M Peron, Ph.D.

[email protected]

(240) 760-6025

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Feasibility & Acceptability9 weeks
Feasibility defined by compliance with viewing \>50% of the weekly videos (proposed target rate of 5 out of 8 videos watched; must watch at least 80% of each video), and 70% of participants attending both coaching sessions 2 and 3. Acceptability defined by descriptive data per caregiver reports of satisfaction on the Study Satisfaction survey (mean of questions 1-7 and 9).
Changes in PSS9 weeks
RCT: Mean scores on the Parental Stress Scale (PSS) will be compared from pre- to post-intervention (baseline to 8 weeks between the immediate intervention arm and the wait list control arm.

Trialytics