NCT05361811

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

Recruiting now NA Last updated 19 February 2026

What this trial tests

NA trial testing Waitlist in Neurofibromatosis 1 in 70 participants. Currently enrolling.

Timeline

10 January 2024

Primary endpoint
1 June 2027

31 December 2027

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	70
Start date	10 January 2024
Primary completion	1 June 2027
Estimated completion	31 December 2027
Sites	1 location across United States

Drugs / interventions tested

• Waitlist
• ACT Intervention

Conditions studied

• Neurofibromatosis 1 — all drugs for Neurofibromatosis 1 →
• Noonan Syndrome — all drugs for Noonan Syndrome →
• Legius Syndrome — all drugs for Legius Syndrome →
• Cardiofaciocutaneous Syndrome — all drugs for Cardiofaciocutaneous Syndrome →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Neurofibromatosis 1 or Noonan Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 stressful. Acceptance and Commitment Therapy (ACT) is a therapy that helps people become more aware and accepting of difficult thoughts and feelings. ACT has been found to be helpful for parents with high parenting stress.

Objective:

To find out if Acceptance and Commitment Therapy (ACT) can help caregivers of children with a RASopathy better cope with parenting stress.

Eligibility:

People aged 18 years or older who care for a child (younger than 18 years) with a RASopathy. The child must live with the caregiver at least 50% of the time.

Design:

The study is fully remote. Participants need a mobile device that can play audio and video and connect to the internet. They can borrow an iPod if needed.

Participants will download a free app called MetricWire. They will use this app to watch videos and answer questions.

The first 8 participants will be in a pilot study. They will receive the ACT intervention starting the first week after they begin the study.

After the pilot study, we will start a new phase called the randomized trial. In this phase, participants will have a 50-50 chance of being in the group that will start the intervention right away or the group that will start the intervention after about 2 months.

Participants will fill out surveys on 5 random days each week. These surveys have 7 questions and take about 2 minutes. They will also fill out 3 longer questionnaires: once before ACT begins, once just after the 8-week study period, and once about 3 months later. Questions will cover topics including:

Parenting stress

Life satisfaction

Self-compassion

Uncomfortable feelings and thoughts

Mindfulness

Participants will take part in an 8-week ACT intervention. They will have one 75-minute session with an ACT coach in the first week.

Participants will watch 9- to 17-minute videos each week. The videos talk about how to practice ACT techniques to cope with parenting stress.

Participants will have 20- to 30-minute coaching sessions in weeks 3 and 6. The coach will help them practice exercises and work through any problems.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.