ACT Intervention for Noonan Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Cancer Institute (NCI), Bethesda, MD
Noonan Syndrome+6 More
ACT Intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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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 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.

Eligible Conditions

  • Noonan Syndrome
  • Cardiofaciocutaneous Syndrome
  • Legius Syndrome
  • Costello Syndrome
  • Watson Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 21 weeks

21 weeks
To determine whether psychological flexibility mediates the relationship between treatment group and parenting stress
To examine changes on caregiver-completed measures of mindfulness, self-compassion, experiential avoidance, depression, and perceptions of child affect from pre- to post-intervention
To examine the feasibility of ecological momentary assessment methods to assess patterns of parenting stress levels over time
9 weeks
Changes in PSS
Feasibility & Acceptability

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

2/Immediate Intervention
1 of 3
3/Waitlist Control
1 of 3
1/Internal Pilot
1 of 3
Active Control
Experimental Treatment

70 Total Participants · 3 Treatment Groups

Primary Treatment: ACT Intervention · No Placebo Group · N/A

1/Internal Pilot
Behavioral
Experimental Group · 1 Intervention: ACT Intervention · Intervention Types: Behavioral
2/Immediate Intervention
Behavioral
ActiveComparator Group · 1 Intervention: ACT Intervention · Intervention Types: Behavioral
3/Waitlist Control
Behavioral
ActiveComparator Group · 1 Intervention: Waitlist · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 21 weeks
Closest Location: National Cancer Institute (NCI) · Bethesda, MD
2004First Recorded Clinical Trial
1 TrialsResearching Noonan Syndrome
176 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are the caregiver of a child with a diagnosis of a RASopathy syndrome.
You are able to understand the information you are being asked to sign and you are willing to sign a written informed consent document.
The participant must live with the child at least 50% of the time.
You have a score of 15 or higher on the modified PSS.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.