Conflict Resolution Program for Mental Health

Recruiting at 2 trial locations

Overseen By E. Mark Cummings, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Notre Dame

Disqualifiers: Non-English speakers, Single parent families

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

Compensation: Varies

Number of Visits: 4

1800 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is designed to test the effectiveness of a psychoeducation-based program to address communication and conflict resolution in families, thereby supporting mental health in children and their caregivers.

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

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

What data supports the effectiveness of the treatment Conflict Resolution Program for Mental Health?

Research shows that psychoeducational family approaches, like those used in the Conflict Resolution Program, have been effective in improving the quality of life for people with mental health issues and their families. These approaches have been successful in reducing relapse rates and improving recovery in conditions like schizophrenia and bipolar disorder. ^{1 2 3 4 5}

Is Parent-Child Interaction Therapy (PCIT) safe for humans?

The research articles do not specifically address safety concerns, but PCIT has been studied internationally for over 40 years and is considered an effective intervention for various behavioral and emotional issues in children, suggesting it is generally safe. ^{6 7 8 9 10}

How is the Parent-Child Interaction Therapy (PCIT) treatment different from other treatments for mental health?

Parent-Child Interaction Therapy (PCIT) is unique because it involves live coaching of parents while they interact with their child, using a one-way mirror and earpiece, which allows for real-time guidance and feedback. This approach focuses on improving the parent's sensitivity and ability to guide their child positively, making it distinct from other treatments that may not involve direct parent-child interaction. ^{6 7 8 9 11}

Eligibility Criteria

This trial is for families with two parents or primary caregivers and at least one child aged between 4 to 17 years. They must be able to read and understand English, and commit to participating in the program through a 12-month follow-up assessment. Single parent families are not eligible.

Inclusion Criteria

English literate

Two parents or primary caregivers

My child is between 4 and 17 years old.

Exclusion Criteria

Single parent families

My family and I cannot communicate in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-test Assessment

Families participate in a pre-test assessment to establish baseline measures

1 week

Intervention

Families participate in a four-week intervention with weekly contact from a family coach and video sessions for feedback and coaching

4 weeks

4 visits (virtual)

Post-test Assessment

Families participate in a post-test assessment to evaluate immediate effects of the intervention

1 week

Follow-up

Participants are monitored for long-term effects of the intervention, including assessments of youth emotional security and adjustment

1 year

Treatment Details

Interventions

• Parent-child intervention
• Self-study Intervention

Trial Overview The study is evaluating a psychoeducation-based conflict resolution program designed for families. It aims to improve communication among family members, focusing on mental health support for both children and their caregivers.

Participant Groups

Group I: Parent-Child Intervention Experimental Treatment 1 Intervention

This is a four-dose intervention that includes psychoeducational modules and communication coaching administered through community organizations over the course of four weeks. Both participating adults and the participating child receive materials to review each week, paired with weekly contact from a family coach.

Group II: Self-study intervention Active Control 1 Intervention

This is a four-dose intervention that include written self-study materials to review, paired with weekly contact with a family coach. Both participating adults receive self-study materials; the participating child does not receive separate materials.

Parent-child intervention is already approved in United States, European Union for the following indications:

Approved in United States as Parent-Child Interaction Therapy for:

• Disruptive Behavior Disorders
• Attention Deficit/Hyperactivity Disorder (ADHD)
• Oppositional Defiant Disorder (ODD)
• Post-Traumatic Stress Disorder (PTSD)
• Autism Spectrum Disorder (ASD)

Approved in European Union as Parent-Child Interaction Therapy for:

• Disruptive Behavior Disorders
• Attention Deficit/Hyperactivity Disorder (ADHD)
• Oppositional Defiant Disorder (ODD)
• Conduct Disorder (CD)

Who Is Running the Clinical Trial?

University of Notre Dame

Lead Sponsor

Trials

36

Recruited

60,000+

Findings from Research

Psychoeducation has been effectively used for over 20 years to support families of patients with psychiatric illnesses, and adapting this approach for patients themselves has shown positive effects on their functioning and attitudes.

The psychoeducation model aims to enhance patients' understanding of their psychiatric conditions and treatments, encourage group discussions for better integration of knowledge, and teach management skills to help them cope with their illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient psychoeducation: the therapeutic use of knowledge for the mentally ill. Hayes, R., Gantt, A.[2015]

Family psychoeducation has evolved over 40 years into a highly effective treatment for schizophrenia, reducing relapse rates by 50-60% compared to standard treatment, based on over 100 outcome studies.

The approach focuses on engaging family members as partners in care, enhancing social functioning and well-being, and has shown promising results in early intervention for first episode and prodromal psychosis, leading to significant improvements in functioning and prevention of psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Interventions for Schizophrenia and the Psychoses: A Review. McFarlane, WR.[2022]

Family psychoeducation is an effective treatment for schizophrenia, bipolar disorder, and major depression, supported by over 30 randomized clinical trials showing reduced relapse rates and improved patient recovery.

Despite its proven benefits, the implementation of family psychoeducation in routine clinical settings faces challenges, including attitudes and knowledge gaps among healthcare providers, which can be addressed through training and support from advocacy organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family psychoeducation and schizophrenia: a review of the literature. McFarlane, WR., Dixon, L., Lukens, E., et al.[2019]

The article discusses the challenges of implementing evidence-based mental health interventions, like Family Group Psychoeducation (FPE), into routine care for individuals with schizophrenia, highlighting the need for effective translation from research to practice.

Using the Consolidated Framework for Implementation Research (CFIR), the article examines key factors influencing the successful integration of FPE into public mental health systems, emphasizing the importance of understanding intervention characteristics and the settings in which they are applied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving an evidence-based intervention into routine mental health care: a multifaceted case example. Ruffolo, MC., Capobianco, J.[2012]

The Meriden Family Programme has successfully trained over 3,900 therapists in Behavioural Family Therapy (BFT), highlighting its effectiveness in improving the quality of life for families affected by serious mental health issues.

A collaborative approach involving management, trainers, therapists, and families is crucial for successfully implementing family work in mental health services, with identified best practices to enhance family involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Meriden Family Programme: lessons learned over 10 years. Fadden, G., Heelis, R.[2022]

Direct-to-consumer advertisements for Parent-Child Interaction Therapy (PCIT) can effectively influence Spanish-speaking parents' intentions to seek help, especially when the messenger is a therapist rather than a parent.

The study highlights the importance of tailored advertising strategies to improve access to mental health services for racial and ethnic minority families, as Spanish-speaking participants showed varying help-seeking intentions based on the messenger used in the advertisements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct-to-Consumer Marketing for Parent-Child Interaction Therapy: Impact of Language and Messenger. Barnett, ML., Bernal, NA., Luis Sanchez, BE.[2022]

Parent-Child Interaction Therapy (PCIT) is an effective intervention for childhood conduct problems, but its adoption by clinicians in routine care settings is still low despite its proven effectiveness.

This systematic review identified only three studies focused on training clinicians in PCIT, highlighting a need for more research on how to support clinicians in adopting and sustaining the use of PCIT after training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician adoption of Parent-Child Interaction Therapy: A systematic review of implementation interventions. Woodfield, MJ., Merry, S., Hetrick, SE.[2023]

Parent-Child Interaction Therapy (PCIT) training for therapists effectively utilized a web-based Video Analysis Tool (VAT) to enhance treatment fidelity by allowing trainers to provide immediate, targeted feedback on recorded therapy sessions.

This innovative approach not only improves the quality of therapy for children with disruptive behavior problems but also enables broader dissemination of PCIT techniques to a global audience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an online viewing system for Parent-Child Interaction therapy consulting with professionals. Wilsie, CC., Brestan-Knight, E.[2012]

Parent-Child Interaction Therapy (PCIT) has been shown to be an effective intervention for treating disruptive behavior problems in children aged 2 to 7, with extensive research supporting its efficacy across various populations over the past decade.

Recent studies have explored adaptations of PCIT for diverse groups, including military families and trauma survivors, as well as new formats like group and home-based sessions, indicating its flexibility and potential for broader application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-Child Interaction Therapy: current perspectives. Lieneman, CC., Brabson, LA., Highlander, A., et al.[2020]

Parent-Child Interaction Therapy (PCIT) is highly effective for treating behavioral problems in children aged 2 to 12, showing a significant mean effect size of -0.87 compared to control groups based on a meta-analysis of 100 studies from 1980 to 2020.

While PCIT demonstrates strong initial effectiveness, the benefits appear to diminish over time, as indicated by a smaller and non-significant effect size of -0.23 during follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of the Efficacy and Effectiveness of Parent Child Interaction Therapy (PCIT) for Child Behaviour Problems. Valero-Aguayo, L., Rodríguez-Bocanegra, M., Ferro-García, R., et al.[2021]

Parent-child interaction therapy, particularly through methods like Theraplay, effectively prevents and addresses children's mental health issues by enhancing parental sensitivity and positive guidance.

Key features that boost the therapy's effectiveness include the simultaneous involvement of both parents, the use of video observation, and fostering a positive collaborative relationship between parents and therapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Theraplay--interactive therapy between parent and child in juvenile mental problems]. Mäkelä, J., Salo, S.[2011]

References

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

Patient psychoeducation: the therapeutic use of knowledge for the mentally ill. [2015]

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

Family Interventions for Schizophrenia and the Psychoses: A Review. [2022]

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

Family psychoeducation and schizophrenia: a review of the literature. [2019]

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

Moving an evidence-based intervention into routine mental health care: a multifaceted case example. [2012]

5. England pubmed.ncbi.nlm.nih.gov

The Meriden Family Programme: lessons learned over 10 years. [2022]

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

Direct-to-Consumer Marketing for Parent-Child Interaction Therapy: Impact of Language and Messenger. [2022]

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

Clinician adoption of Parent-Child Interaction Therapy: A systematic review of implementation interventions. [2023]

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

Using an online viewing system for Parent-Child Interaction therapy consulting with professionals. [2012]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Parent-Child Interaction Therapy: current perspectives. [2020]

10. Spain pubmed.ncbi.nlm.nih.gov

Meta-analysis of the Efficacy and Effectiveness of Parent Child Interaction Therapy (PCIT) for Child Behaviour Problems. [2021]

11. Finland pubmed.ncbi.nlm.nih.gov

[Theraplay--interactive therapy between parent and child in juvenile mental problems]. [2011]