Therapy to help caregivers of children with genetic disorders manage stress
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and Follow-up Phase III Randomized Controlled Trial
This study tests whether a remote therapy program can help caregivers of children with genetic disorders manage their stress better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05361811 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Acceptance and Commitment Therapy (ACT) in helping caregivers of children with RASopathies cope with parenting stress. It involves a fully remote intervention where participants use a mobile app to access therapy resources. The study includes an internal pilot to assess feasibility and a randomized controlled trial to measure changes in parental stress levels over eight weeks. Caregivers will be compared between an immediate intervention group and a waitlist control group.
Who should consider this trial
Good fit: Ideal candidates are caregivers aged 18 or older who care for a child under 18 with a RASopathy and experience moderate parenting stress.
Not a fit: Patients who are not caregivers of children with RASopathies or those not experiencing significant parenting stress may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce parenting stress for caregivers of children with RASopathies.
How similar studies have performed: While similar psychological interventions have shown promise in reducing parenting stress, this specific application of ACT for RASopathy caregivers is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: * 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 CRITERIA: * 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
Where this trial is running
Bethesda, Maryland
- National Cancer Institute (NCI) — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Staci M Peron, Ph.D. — National Cancer Institute (NCI)
- Study coordinator: Staci M Peron, Ph.D.
- Email: Staci.Martin@nih.gov
- Phone: (240) 760-6025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.