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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Acceptance and Commitment Therapy (ACT) can help caregivers of children with RASopathies (a group of genetic conditions affecting development) manage parenting stress more effectively. Participants will use an app to watch videos and answer questions as part of an 8-week program, which includes video sessions and coaching. It suits caregivers who live with a child diagnosed with a RASopathy at least half the time and experience moderate parenting stress. As an unphased trial, this study provides caregivers the chance to explore innovative support strategies tailored to their unique challenges.

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 prior data suggests that Acceptance and Commitment Therapy (ACT) is safe for caregivers of children with genetic syndromes?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally easy for caregivers to manage. One study found that ACT effectively reduced anxiety, depression, and stress in caregivers. This therapy helps individuals accept difficult thoughts and feelings, which can be particularly beneficial for those caring for children with long-term health issues.

Another study suggested that ACT could be even more effective when parents participate in the therapy. Although ACT is not a new treatment, it has shown promise in helping caregivers manage stress and improve their mental well-being. Overall, ACT appears to be a safe choice for caregivers seeking to better handle their challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Acceptance and Commitment Therapy (ACT) is unique because it focuses on helping caregivers manage stress and emotional challenges by promoting psychological flexibility. Unlike traditional therapy options that might center around problem-solving or symptom reduction, ACT encourages individuals to accept their feelings and commit to actions aligned with their values, even in the face of difficult emotions. Researchers are excited about this approach because it offers a holistic way to enhance the well-being of caregivers, which can ultimately lead to better support and outcomes for children with genetic syndromes. This method stands out by potentially improving mental health without the need for medication, making it an appealing option for those seeking non-pharmacological interventions.

What evidence suggests that Acceptance and Commitment Therapy (ACT) might be an effective treatment for parenting stress in caregivers of children with RASopathies?

Research has shown that Acceptance and Commitment Therapy (ACT) can help parents manage stress. One study found that ACT moderately reduced stress in parents of children with special needs. Another study demonstrated that ACT-based programs lowered parents' levels of depression, anxiety, and stress, while increasing their flexibility in handling challenges. Additionally, a specific ACT program significantly reduced parents' distress and improved their quality of life. In this trial, participants will receive ACT either immediately, after a waitlist period, or as part of an internal pilot to assess feasibility. These findings suggest that ACT could be a helpful tool for caregivers of children with genetic syndromes to better cope with parenting stress. ^{3 6 7 8 9}

Who Is on the Research Team?

Staci M Peron, Ph.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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) 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]

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) 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]

Citations

1. journals.sagepub.com journals.sagepub.com/doi/10.1037/cpp0000551

A Pilot Acceptance and Commitment Intervention for ... This study examined the overall feasibility of conducting an intervention targeting stress in parents of children with genetic syndromes. Most parents ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12278553/

The effectiveness of Acceptance and Commitment Therapy ... This meta-analysis confirmed that ACT moderately reduces stress among parents of children with special needs (SMD =– 0.42, 95% CI– 0.72 to– 0.12 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2212144725000043

Acceptance and commitment therapy (ACT) for pediatric ... ACT could be efficacious in the treatment of paediatric CNCP; furthermore, the inclusion of parents could lead to improved outcomes.

4. researchgate.net researchgate.net/publication/363559067_Effects_of_Acceptance_and_Commitment_Therapy-based_interventions_on_the_mental_states_of_parents_with_special_needs_children_Randomized_controlled_trial

Effects of Acceptance and Commitment Therapy-based ... The ACT-based interventions implemented with parents were effective in decreasing parents' levels of psychological inflexibility, depression, anxiety, stress, ...

5. publications.aap.org publications.aap.org/pediatrics/article/156/4/e2025071134/204188/Acceptance-and-Commitment-Therapy-for-Parents-of

Acceptance and Commitment Therapy for Parents of ... Our study demonstrated that a 4-session ACT-based intervention significantly reduced parental psychological distress, improved QoL, enhanced ...

6. ui.adsabs.harvard.edu ui.adsabs.harvard.edu/abs/2023JCBS...27...72W/abstract

Acceptance and commitment therapy (ACT) for caregivers ... Acceptance and commitment therapy (ACT) for caregivers of children with chronic conditions: A mixed methods systematic review (MMSR) of efficacy, process, and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12216695/

Acceptance and commitment therapy among caregivers of ... This study revealed that ACT intervention can effectively alleviate caregivers' anxiety, depression, and stress symptoms, which is consistent ...

8. researchgate.net researchgate.net/publication/353665422_Acceptance_and_Commitment_Therapy_for_Children_with_Special_Health_Care_Needs_and_Their_Parents_A_Systematic_Review_and_Meta-Analysis

(PDF) Acceptance and Commitment Therapy for Children ... There is some evidence that ACT may help with depressive symptoms in children with SHCN and psychological inflexibility in their parents.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39816616/

Acceptance and commitment therapy group protocol for ... This pilot study evaluates the preliminary efficacy of a group-delivered caregiver treatment program, ACT for Parents of Anxious Children (ACT- ...