Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05361811
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2022-05-03
Brief Title:
Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy An Internal Pilot Feasibility Study and Follow-up Randomized Controlled Trial
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Background
RASopathies are a group of neurodevelopmental genetic conditions caused by mutations affecting components within the RAS-map kinase RAS-MAPK cellular signaling pathway
Caregivers of children with a RASopathy are faced with numerous challenges related to the physical cognitive and behavioral symptoms associated with their child s condition
The use of virtual interventions has been increasing over the past decade which increase accessibility and are especially critical during times of physical distancing such as due to COVID-19
Similarly Ecological Momentary Assessments EMA are being utilized more frequently in order to maximize ecological validity of results and minimize recall bias
To our knowledge no psychological interventions have been investigated targeting parenting stress among caregivers of a child with a RASopathy
Primary Objectives
Internal Pilot Study To assess the feasibility eg enrollment and attrition and acceptability eg satisfaction of an Acceptance and Commitment Therapy ACT coping intervention on parenting stress for caregivers of a child with a RASopathy
Randomized Controlled Trial RCT To compare Parental Stress Scale PSS changes from baseline to 8 weeks between the Immediate Intervention Arm and the Waitlist Control Arm
Eligibility
Caregiver parent or legal guardian of a child 18 years residing with them at least 50 of the time who has a diagnosis of RASopathy syndrome including NF1 Noonan Syndrome Legius Syndrome Cardiofaciocutaneous CFC syndrome and Costello Syndrome or another RASopathy
Access to necessary resources for participating in a technology-based intervention ie computer smartphone internet access or be willing to use an iPod provided by the study team
Must score a 15 or higher total score on modified questions from the PSS to indicate at least a moderate level of parenting stress
Ability to read and speak English
Design
This is an 8-week psychological intervention study that has two phases the first an internal pilot study will enroll an initial small cohort of caregivers n 8 all of whom will participate in the ACT intervention COMPLETE
Due to the success of the internal pilot study with specific benchmarks met the second phase of this study will be an RCT comparing participants who receive the intervention immediately Immediate Intervention Arm with those in a control group Waitlist Control Arm Participants randomized to the Waitlist Control Arm will cross over to receive the intervention after the waitlist period
The intervention for the RCT phase involves a baseline 90-minute coaching session and two follow-up coaching sessions with a therapist over video chat followed by weekly prerecorded video modules that the participants can view at their convenience over the following 8 weeks
Participants will complete measures of parenting stress mindfulness psychological flexibility self-compassion and perceptions of child well-being at baseline the 8-week post-intervention assessment and a 3-month follow-up assessment Additionally the study will use EMA whereby questions will be sent electronically at random times and days once a day at varying times on 5 days a week during weeks 0-8 the first week will serve as baseline data for comparison for the Immediate Intervention Arm and weeks 0-18 for the Waitlist Control Arm using the Catalyst mobile applicatioon by MetricWire software
We plan to enroll 8 participants in the internal pilot phase and 56 participants in the RCT phase to account for the potential attrition of two caregivers from the intervention for a total accrual target of 64 evaluable participants
RASopathies are a group of neurodevelopmental genetic conditions caused by mutations affecting components within the RAS-map kinase RAS-MAPK cellular signaling pathway
Caregivers of children with a RASopathy are faced with numerous challenges related to the physical cognitive and behavioral symptoms associated with their child s condition
The use of virtual interventions has been increasing over the past decade which increase accessibility and are especially critical during times of physical distancing such as due to COVID-19
Similarly Ecological Momentary Assessments EMA are being utilized more frequently in order to maximize ecological validity of results and minimize recall bias
To our knowledge no psychological interventions have been investigated targeting parenting stress among caregivers of a child with a RASopathy
Primary Objectives
Internal Pilot Study To assess the feasibility eg enrollment and attrition and acceptability eg satisfaction of an Acceptance and Commitment Therapy ACT coping intervention on parenting stress for caregivers of a child with a RASopathy
Randomized Controlled Trial RCT To compare Parental Stress Scale PSS changes from baseline to 8 weeks between the Immediate Intervention Arm and the Waitlist Control Arm
Eligibility
Caregiver parent or legal guardian of a child 18 years residing with them at least 50 of the time who has a diagnosis of RASopathy syndrome including NF1 Noonan Syndrome Legius Syndrome Cardiofaciocutaneous CFC syndrome and Costello Syndrome or another RASopathy
Access to necessary resources for participating in a technology-based intervention ie computer smartphone internet access or be willing to use an iPod provided by the study team
Must score a 15 or higher total score on modified questions from the PSS to indicate at least a moderate level of parenting stress
Ability to read and speak English
Design
This is an 8-week psychological intervention study that has two phases the first an internal pilot study will enroll an initial small cohort of caregivers n 8 all of whom will participate in the ACT intervention COMPLETE
Due to the success of the internal pilot study with specific benchmarks met the second phase of this study will be an RCT comparing participants who receive the intervention immediately Immediate Intervention Arm with those in a control group Waitlist Control Arm Participants randomized to the Waitlist Control Arm will cross over to receive the intervention after the waitlist period
The intervention for the RCT phase involves a baseline 90-minute coaching session and two follow-up coaching sessions with a therapist over video chat followed by weekly prerecorded video modules that the participants can view at their convenience over the following 8 weeks
Participants will complete measures of parenting stress mindfulness psychological flexibility self-compassion and perceptions of child well-being at baseline the 8-week post-intervention assessment and a 3-month follow-up assessment Additionally the study will use EMA whereby questions will be sent electronically at random times and days once a day at varying times on 5 days a week during weeks 0-8 the first week will serve as baseline data for comparison for the Immediate Intervention Arm and weeks 0-18 for the Waitlist Control Arm using the Catalyst mobile applicatioon by MetricWire software
We plan to enroll 8 participants in the internal pilot phase and 56 participants in the RCT phase to account for the potential attrition of two caregivers from the intervention for a total accrual target of 64 evaluable participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000657-C | None | None | None |