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

Trial Summary

What is the purpose of this trial?

This is a randomized clinical trial of Focused Acceptance and Commitment Therapy (FACT) vs. an attention-control condition (placebo) for improving the mental health of parents of children with pediatric feeding disorder. The goal of this clinical trial is to compare two programs in parents of children with pediatric feeding disorders. The main question\[s\] it aims to answer are: FACT will result in clinically meaningful reductions in Mental Health(MH) problems among parents of children with Pediatric Feed Disorder (PFD) Identify factors that impact the feasibility of FACT delivery Participants will asked to participate in one of two programs focused on parents of children with pediatric feeding disorders. The participants will also be asked to complete a battery of questionnaires at four timepoints during the study. The parents will be asked to video record a meal time three times during study. Researchers will compare the FACT group with a control group to see if FACT will result in clinically meaningful change in parent stress and anxiety, and parent use of positive mealtime behaviors.

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 data supports the effectiveness of the treatment Focused Acceptance and Commitment Therapy (FACT) for parental mental health?

Research shows that Focused Acceptance and Commitment Therapy (FACT) can improve quality of life and reduce symptoms of depression, anxiety, and stress. This is based on studies where FACT was used in a group setting, demonstrating large positive effects on participants' mental health. ^{1 2 3 4 5}

Is Focused Acceptance and Commitment Therapy (FACT) safe for humans?

The research on Focused Acceptance and Commitment Therapy (FACT) does not specifically mention safety concerns, but it is based on Acceptance and Commitment Therapy (ACT), which is generally considered safe for improving mental health by helping people accept their thoughts and feelings. ^{1 2 4 5 6}

How is Focused Acceptance and Commitment Therapy (FACT) different from other treatments for parental mental health?

Focused Acceptance and Commitment Therapy (FACT) is unique because it is a brief version of Acceptance and Commitment Therapy (ACT) that emphasizes improving psychological flexibility, helping parents accept their thoughts and feelings, and encouraging them to focus on actions aligned with their values. This approach is distinct from other therapies by its short duration and focus on mindfulness and acceptance skills. ^{1 2 4 5 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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) 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]

References

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

The efficacy of Focused Acceptance and Commitment Therapy in VA primary care. [2019]

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

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. [2018]

4. Australia pubmed.ncbi.nlm.nih.gov

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

5. France pubmed.ncbi.nlm.nih.gov

[Acceptance and commitment therapy]. [2019]

6. 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]

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

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