Therapy to help caregivers of children with genetic disorders manage stress

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.