Focused Acceptance and Commitment Therapy for Parental Mental Health

(FACT Trial)

Overseen By Corey Schurman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Cognitive impairments, Non-English speakers, No internet

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two programs aimed at improving the mental health of parents with children who have pediatric feeding disorders. One program uses Focused Acceptance and Commitment Therapy (FACT), a specialized counseling method to reduce stress and anxiety. The other program offers general advice on nutrition and healthy lifestyle choices. Researchers aim to determine if FACT can enhance mental health and promote positive mealtime behaviors in parents. Suitable participants have children aged 2-6 receiving outpatient care for feeding disorders and experience noticeable stress or anxiety. As an unphased trial, this study provides a unique opportunity for parents to explore innovative support methods for managing stress and improving family mealtime dynamics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Focused Acceptance and Commitment Therapy (FACT) is safe for improving parental mental health?

Previous studies have shown that Focused Acceptance and Commitment Therapy (FACT) can improve mental health by reducing symptoms of depression, anxiety, and stress. This therapy is particularly beneficial for parents in stressful situations, such as caring for children with special needs. Research indicates that FACT is generally well-tolerated, with most people experiencing no serious issues. No major side effects have been reported, suggesting it is a safe option for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Focused Acceptance and Commitment Therapy (FACT) for parental mental health because it offers a fresh approach compared to traditional therapies, like Cognitive Behavioral Therapy (CBT) or medication. FACT is unique because it delivers targeted interventions in just two sessions, focusing on helping individuals accept their thoughts and feelings and commit to personal values and actions. This brief and focused method could lead to quicker, more sustainable improvements in mental health for parents, making it an appealing alternative to longer, more intensive treatments.

What evidence suggests that Focused Acceptance and Commitment Therapy is effective for improving parental mental health?

Research shows that Focused Acceptance and Commitment Therapy (FACT), which participants in this trial may receive, can improve mental health by reducing symptoms of depression, anxiety, and stress. Studies have found that FACT effectively lowers stress levels among parents of children with special needs. One study showed a significant stress reduction with a score change of -0.42. Additionally, FACT has improved quality of life and overall mental health more effectively than usual care. Therefore, evidence suggests that FACT could enhance mental health for parents considering joining this trial. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for parents of children with pediatric feeding disorders. To join, they must be willing to participate in therapy sessions and complete questionnaires at different times during the study. They should also be okay with video recording meal times. Parents who might not benefit from FACT or have conditions that could interfere with the therapy are excluded.

Inclusion Criteria

The parent must have a clinically significant elevation on at least one measure of parent MH (using established clinical cutoffs). Parents will be included regardless of whether the child has a new diagnosis or established diagnoses

I am the main caregiver, over 18, of a child aged 2-6 with feeding difficulties.

My child is getting outpatient PFD treatment at CMH.

Exclusion Criteria

My parent has major memory or thinking problems.

Parent unable to obtain high speed internet at home

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Focused Acceptance and Commitment Therapy (FACT) or an attention-control condition over two 90-minute sessions, 2 weeks apart

4 weeks

2 visits (virtual)

Follow-up

Participants are monitored for changes in mental health and parenting behaviors through questionnaires and video recordings

3 months

4 timepoints for questionnaires, 3 video recordings

What Are the Treatments Tested in This Trial?

Interventions

• Focused Acceptance and Commitment Therapy (FACT)

Trial Overview

The trial is testing Focused Acceptance and Commitment Therapy (FACT) against a control condition to see if it helps reduce mental health problems in these parents. It will involve attending therapy programs and monitoring changes through questionnaires and recorded mealtime interactions.

How Is the Trial Designed?

Group I: FACT Experimental Treatment 1 Intervention

Behavioral: Focused Acceptance and Commitment Therapy (FACT) FACT is a 2-session intervention based on the Focused Acceptance and Commitment Therapy treatment literature

Group II: Control Active Control 1 Intervention

The content of the control intervention covers a range of nutrition and healthy lifestyle topics including USDA's MyPlate

Focused Acceptance and Commitment Therapy (FACT) is already approved in United States, European Union for the following indications:

Approved in United States as Focused Acceptance and Commitment Therapy for:

• Anxiety disorders
• Depression
• Chronic pain
• Substance abuse
• Pediatric feeding disorders-related parental stress

Approved in European Union as Focused Acceptance and Commitment Therapy for:

• Anxiety disorders
• Depression
• Chronic pain
• Substance abuse
• General mental health issues

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A 4-week group intervention using Focused Acceptance & Commitment Therapy (FACT) with 51 patients in a VA primary care setting showed significant improvements in quality of life and reductions in depressive symptoms, indicating its potential efficacy for mental health treatment.

The study found moderate effects on mental health functioning and small effects on perceived stress and physical health, suggesting that FACT can positively impact various aspects of well-being, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of Focused Acceptance and Commitment Therapy in VA primary care. Glover, NG., Sylvers, PD., Shearer, EM., et al.[2019]

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) showed significant improvements in global mental health, depression, cognitive fusion, and values in complex clients treated by both psychologists and non-psychologists in a National Health Service setting.

The positive effects of ACT were partially maintained at a 3-month follow-up, indicating its potential long-term benefits, and outcomes were similar regardless of the therapist's professional background.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of Acceptance and Commitment Therapy Delivered by Psychologists and Non-Psychologists in an NHS Community Adult Mental Health Service: a Preliminary Analysis. Richardson, T., Bell, L., Bolderston, H., et al.[2018]

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) 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) 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]

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]

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