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NCT05361811 · ClinicalTrials.gov registry record · NA
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial
A NA study of Neurofibromatosis 1 and Noonan Syndrome, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT05361811 is a NA study of Neurofibromatosis 1 and Noonan Syndrome that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 70 participants, below the 1,033-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05361811, a NA study of Neurofibromatosis 1 and Noonan Syndrome, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Conditions Studied
Interventions
- BEHAVIORAL Waitlist
- BEHAVIORAL ACT Intervention
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-01-10 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05361811
The ClinicalTrials.gov registry entry for NCT05361811 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,033-participant average among 24 other Neurofibromatosis 1 trials with a reported enrollment target (93% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Neurofibromatosis 1 appearing as the primary indexed condition, and to 2 interventions - of which Waitlist is the first listed.
NCT05361811 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05361811 about?
NCT05361811 is a clinical study titled "Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial". 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 acce...
What is the current status of trial NCT05361811?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2024-01-10. Estimated completion is 2027-12-31.
What conditions does trial NCT05361811 study?
This clinical trial studies the following conditions: Neurofibromatosis 1, Noonan Syndrome, Legius Syndrome, Cardiofaciocutaneous Syndrome, Costello Syndrome.
What interventions are being tested in trial NCT05361811?
The interventions under investigation include: Waitlist (BEHAVIORAL), ACT Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05361811?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05361811 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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