Actively Recruiting
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Phase III Randomized Controlled Trial
Led by National Cancer Institute (NCI) · Updated on 2026-02-19
70
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
RASopathies are genetic conditions that affect children's development, causing physical, cognitive, and behavioral challenges. This research aims to find out if Acceptance and Commitment Therapy (ACT), a technique that helps people accept difficult thoughts and feelings, can help caregivers of children with RASopathies manage parenting stress. The study includes an initial pilot phase followed by a randomized trial to compare immediate versus delayed intervention effects. The study involves an 8-week ACT intervention delivered remotely through a mobile app called MetricWire. Participants watch weekly videos lasting 9 to 17 minutes and engage in coaching sessions via video chat—one 75-minute session in week 1 and shorter 20- to 30-minute sessions in weeks 3 and 6. The trial has two phases: a pilot study where all participants receive the intervention immediately, and a randomized controlled trial where participants either start the intervention right away or after approximately 2 months on a waitlist. Caregivers aged 18 or older who care for a child under 18 with a RASopathy and live with the child at least half the time are eligible. They will complete brief daily surveys five days a week and longer questionnaires before and after the intervention, as well as three months later. These assessments measure parenting stress, mindfulness, self-compassion, and related factors. The study monitors feasibility, acceptability, and changes in stress levels over time using electronic assessments and questionnaires.
CONDITIONS
Brief Title
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent
- Ability to read and speak English
- Age 18 years or older
- Caregiver of a child under 18 years with a diagnosis of a RASopathy syndrome including NF1, Noonan Syndrome, Legius Syndrome, CFC, or Costello Syndrome
- Child with RASopathy must live with caregiver at least 50% of the time
- Access to computer, smartphone, internet or willingness to use an iPod provided by the study
- Moderate level of parenting stress with a score of 15 or higher on the Parental Stress Scale
- Not currently participating or planning to participate in psychosocial interventions mainly targeting parenting stress during the study
You will not qualify if you...
- Another caregiver in the same household is participating in this study
- Uncontrolled psychiatric illness, cognitive impairments, or other conditions limiting compliance as judged by the Principal Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) to assess eligibility and complete consent
Duration - 1 week
Participants complete a 1-week baseline period of ecological momentary assessments (EMA) to collect initial data on parenting stress.
Daily EMA prompts 5 days a week via mobile application
Duration - 8 weeks
Participants receive an 8-week Acceptance and Commitment Therapy (ACT) intervention focusing on mindfulness, acceptance, perspective taking, and values-based actions. This includes a baseline 90-minute coaching session, two follow-up coaching sessions over video chat, and weekly prerecorded video modules.
1 baseline coaching session and 2 follow-up video chat sessions; weekly access to prerecorded video modules
Duration - Up to 3 months post-intervention
Participants complete follow-up assessments at 8 weeks post-intervention and again at 3 months to measure changes in parenting stress and related outcomes.
2 assessment visits or virtual sessions (at 8 weeks and 3 months post-intervention)
Trial Site Locations
Total: 1 location
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Staci M Peron, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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