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Acceptance and Commitment Therapy for Caregivers of Children with Genetic Syndromes
N/A
Recruiting
Led By Staci M Peron, Ph.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 weeks
Awards & highlights
Study Summary
This trial will test whether Acceptance and Commitment Therapy (ACT) can help caregivers of children with a RASopathy better cope with parenting stress.
Who is the study for?
This trial is for caregivers aged 18 or older who look after a child with a RASopathy syndrome, such as Neurofibromatosis or Noonan Syndrome. The child must live with them at least half the time. Caregivers should be experiencing moderate parenting stress and have access to technology like smartphones or computers for remote participation.Check my eligibility
What is being tested?
The study tests if Acceptance and Commitment Therapy (ACT) can reduce stress in caregivers of children with RASopathies. It's fully remote, using an app for videos and surveys. Participants will either start ACT immediately or after a waitlist period, determined by chance.See study design
What are the potential side effects?
As this trial involves psychological therapy rather than medication, traditional physical side effects are not expected. However, participants may experience emotional discomfort when engaging with challenging thoughts and feelings during the therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowSelect...
I am a caregiver not involved in stress-related parenting programs during the study.
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I am the caregiver of a child with a RASopathy syndrome.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in PSS
Feasibility & Acceptability
Secondary outcome measures
To determine whether psychological flexibility mediates the relationship between treatment group and parenting stress
To examine changes on caregiver-completed measures of psychological flexibility, 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
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: 1/Internal PilotExperimental Treatment1 Intervention
Participants will begin their 1-week baseline EMA data collection period and then take part in intervention procedures immediately after enrollment to assess feasibility and acceptability.
Group II: 2/Immediate InterventionActive Control1 Intervention
Participants will begin their 1-week baseline EMA data collection period immediately after randomization and will begin receiving the 8-week intervention at the end of this week/beginning of the next week (depending on participant schedule).
Group III: 3/Waitlist ControlActive Control1 Intervention
After an initial 1-week baseline period for EMA data collection and 8 weeks of maintaining their usual routine (wait list period), participants will begin receiving the 8-week intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACT Intervention
2022
N/A
~30
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,271 Total Patients Enrolled
3 Trials studying Neurofibromatosis
284 Patients Enrolled for Neurofibromatosis
Staci M Peron, Ph.D.Principal InvestigatorNational Cancer Institute (NCI)
7 Previous Clinical Trials
431 Total Patients Enrolled
2 Trials studying Neurofibromatosis
274 Patients Enrolled for Neurofibromatosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Another caregiver in my home is already part of this study.You need to score 15 or higher on a set of questions about parental stress, showing that you feel moderately stressed as a parent.I am a caregiver not involved in stress-related parenting programs during the study.I am the caregiver of a child with a RASopathy syndrome.If you have a child with RASopathy, they must live with you at least half of the time.I started taking psychiatric medication less than 4 weeks ago.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: 2/Immediate Intervention
- Group 2: 1/Internal Pilot
- Group 3: 3/Waitlist Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment accessible to the public at present?
"According to clinicaltrials.gov, this research project is seeking participants and was initially announced on December 5th 2022 before being updated November 29th 2022."
Answered by AI
How many individuals have been selected to participate in this investigation?
"Affirmative, according to information hosted on clinicaltrials.gov this trial is still recruiting participants since it was first posted December 5th 2022 and last modified November 29th 2022. 70 individuals are needed for the single site of the study."
Answered by AI
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