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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 weeks

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 1Eligibility criteria met