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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
Age >= 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 weeks
Awards & highlights

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.
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.
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 “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in PSS
Feasibility & Acceptability
Secondary study objectives
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
13,842 Previous Clinical Trials
41,002,930 Total Patients Enrolled
3 Trials studying Neurofibromatosis
290 Patients Enrolled for Neurofibromatosis
Staci M Peron, Ph.D.Principal InvestigatorNational Cancer Institute (NCI)
7 Previous Clinical Trials
437 Total Patients Enrolled
2 Trials studying Neurofibromatosis
280 Patients Enrolled for Neurofibromatosis

Media Library

Acceptance and Commitment Therapy (ACT) Clinical Trial Eligibility Overview. Trial Name: NCT05361811 — N/A
Neurofibromatosis Research Study Groups: 2/Immediate Intervention, 1/Internal Pilot, 3/Waitlist Control
Neurofibromatosis Clinical Trial 2023: Acceptance and Commitment Therapy (ACT) Highlights & Side Effects. Trial Name: NCT05361811 — N/A
Acceptance and Commitment Therapy (ACT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05361811 — N/A
~46 spots leftby Dec 2025
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