What this study is
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.
What's being tested
- Waitlist
Intervention · BEHAVIORAL
8 weeks of maintaining usual routine followed by 8-week intervention that emphasizes mindfulness, acceptance, perspective taking, and values-based actions.
- ACT Intervention
Intervention · BEHAVIORAL
8-week intervention that emphasizes mindfulness, acceptance, perspective taking, and values-based actions.
Study details
- Official title
- Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Phase III Randomized Controlled Trial
- Sponsor
- National Cancer Institute (NCI)
- Conditions
- Neurofibromatosis 1 · Noonan Syndrome · Legius Syndrome · Cardiofaciocutaneous Syndrome · Costello Syndrome
- Enrolling
- 70 people
- Starts
- 2024-01-10
- Est. completion
- 2027-12-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openNational Cancer Institute (NCI)
Bethesda, Maryland, United States
- Staci Peron, Ph.D. · Contact240-760-6025martins@mail.nih.gov
Recruiting
Study team
Sponsor
National Cancer Institute (NCI)
Study ID 10000657
Principal investigator
Staci M Peron, Ph.D.
National Cancer Institute (NCI)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.