Acceptance and Commitment Therapy for Caregivers of Children with Genetic Syndromes

Overseen By Staci M Peron, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Must not be taking: Psychiatric medications

Disqualifiers: Uncontrolled psychiatric illness, cognitive impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, if you started taking psychiatric medication less than 4 weeks before enrolling, you may not be eligible.

What data supports the effectiveness of the treatment Acceptance and Commitment Therapy (ACT) for caregivers of children with genetic syndromes?

Research shows that Acceptance and Commitment Therapy (ACT) can help reduce stress, anxiety, and depression, and improve quality of life in various groups, including parents of children with chronic conditions. This suggests it may also be beneficial for caregivers of children with genetic syndromes. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy (ACT) safe for humans?

Acceptance and Commitment Therapy (ACT) is generally considered safe for humans, as it focuses on improving psychological flexibility and mindfulness without involving medication or invasive procedures. ^{1 2 3 4 6}

How is Acceptance and Commitment Therapy (ACT) different from other treatments for caregivers of children with genetic syndromes?

Acceptance and Commitment Therapy (ACT) is unique because it focuses on helping caregivers align their actions with personal values and develop mindfulness and acceptance skills to handle stress, rather than trying to change or eliminate difficult thoughts and feelings. ^{1 2 3 5 6}

Research Team

Staci M Peron, Ph.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

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.

Inclusion Criteria

Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access) or be willing to use an iPod provided by study team

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.

Exclusion Criteria

Another caregiver in my home is already part of this study.

I started taking psychiatric medication less than 4 weeks ago.

Uncontrolled psychiatric illness, cognitive impairments, or other circumstance as judged by the Principal Investigator, a licensed psychologist, that would limit compliance with study requirements

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Remote screening via app

Internal Pilot Study

Initial cohort of 8 participants undergoes the ACT intervention to assess feasibility and acceptability

8 weeks

Remote sessions and app-based activities

Randomized Controlled Trial (RCT)

Participants are randomized to either immediate intervention or waitlist control, with intervention starting after a 1-week baseline period

9 weeks

Remote sessions and app-based activities

Follow-up

Participants are monitored for changes in parenting stress and other psychological measures post-intervention

3 months

Remote surveys and assessments

Treatment Details

Interventions

• Acceptance and Commitment Therapy (ACT)

Trial Overview 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.

Participant Groups

Group I: 1/Internal Pilot Experimental Treatment 1 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 Intervention Active Control 1 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 Control Active Control 1 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

Acceptance and Commitment Therapy (ACT) has shown effectiveness in improving outcomes for patients with chronic pain and may also benefit those with mild to moderate depression, making it a valuable tool for general practitioners.

ACT employs mindfulness and acceptance strategies to help patients align their behaviors with their values, and it has shown preliminary benefits in various conditions, including obsessive-compulsive disorder and emotional issues after gastric band surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy - pathways for general practitioners. Smout, M.[2012]

Internet-based Acceptance and Commitment Therapy (iACT) shows small effects in reducing depressive symptoms, anxiety, stress, psychological distress, and improving quality of life, based on a systematic review of 39 randomized controlled trials.

While iACT was effective compared to passive control groups, it did not show significant advantages over active control groups, indicating the need for further high-quality studies to compare its efficacy with other established therapies like cognitive behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Internet-Based Acceptance and Commitment Therapy for Depressive Symptoms, Anxiety, Stress, Psychological Distress, and Quality of Life: Systematic Review and Meta-analysis. Han, A., Kim, TH.[2022]

Acceptance and Commitment Therapy (ACT) shows promise in reducing mental health symptoms in children and adolescents, with ten studies indicating improvements in conditions like anxiety and depression.

While ACT was effective in increasing psychological flexibility and reducing symptoms, similar benefits were also observed with other active interventions, suggesting the need for further research to clarify ACT's unique contributions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy: A Systematic Literature Review of Prevention and Intervention Programs for Mental Health Difficulties in Children and Young People. Harris, E., Samuel, V.[2021]

Acceptance and Commitment Therapy (ACT) is a promising form of therapy that incorporates mindfulness techniques and has shown effectiveness for various psychiatric disorders in adults.

Research on adapting ACT for youth is still developing, indicating a need for more studies to establish its efficacy and safety in younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy (ACT): advances and applications with children, adolescents, and families. Coyne, LW., McHugh, L., Martinez, ER.[2011]

A study involving 110 parents of children with chronic conditions showed that both an internet-based ACT intervention (iACT) and a self-help ACT program effectively reduced burnout, but the iACT led to greater improvements in depression, psychological flexibility, and mindfulness skills.

The iACT intervention, which included three video conferencing sessions with a psychologist, was more effective in enhancing overall psychological well-being compared to the self-help approach, suggesting that internet-delivered psychological support can be a valuable resource for parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting parents of children with chronic conditions: A randomized controlled trial of web-based and self-help ACT interventions. Lappalainen, P., Pakkala, I., Strömmer, J., et al.[2022]

Acceptance and Commitment Therapy (ACT) effectively enhances psychological flexibility and has shown efficacy in treating a variety of psychiatric disorders, including depression, anxiety, and PTSD, with a meta-analysis revealing an average effect size of 0.66 at post-treatment across 704 participants.

ACT not only improves mental health outcomes but also benefits other medical areas such as chronic pain management and smoking cessation, demonstrating its versatility and positive impact on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Acceptance and commitment therapy]. Ducasse, D., Fond, G.[2019]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy - pathways for general practitioners. [2012]

2. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of Internet-Based Acceptance and Commitment Therapy for Depressive Symptoms, Anxiety, Stress, Psychological Distress, and Quality of Life: Systematic Review and Meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy: A Systematic Literature Review of Prevention and Intervention Programs for Mental Health Difficulties in Children and Young People. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy (ACT): advances and applications with children, adolescents, and families. [2011]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Supporting parents of children with chronic conditions: A randomized controlled trial of web-based and self-help ACT interventions. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[Acceptance and commitment therapy]. [2019]