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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help families improve communication and resolve conflicts, potentially boosting mental health for children and their caregivers. Participants will either engage in a self-study approach, where parents review materials and have weekly check-ins with a family coach, or participate in a parent-child intervention (known as Parent-Child Interaction Therapy, or PCIT) that includes weekly modules and coaching. Families with two caregivers and a child aged 4 to 17, who are comfortable with English, might find this trial suitable. As an unphased trial, the study offers families the chance to explore innovative methods for enhancing family dynamics and mental health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the parent-child intervention is based on Parent-Child Interaction Therapy (PCIT), a well-researched method for assisting children and their parents or caregivers. Studies indicate that PCIT can reduce parenting stress, decrease challenging child behaviors, and improve caregiver mental health. No major safety concerns have been reported with this treatment, making it generally well-tolerated.

Family psychoeducation, used in the self-study intervention, has a long history. It has lowered relapse rates in mental health conditions like schizophrenia. This intervention is non-invasive and focuses on learning and improving communication, making it safe for participants.

Both interventions aim to enhance family communication and mental health, with no significant safety issues reported in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Conflict Resolution Program for Mental Health because it offers unique approaches to improving family dynamics and mental health. Unlike standard treatments, which may involve individual therapy or medication, this trial explores a parent-child intervention that includes psychoeducational modules and communication coaching. This method fosters direct family engagement, providing both adults and children with materials to enhance their interactions. Additionally, the self-study intervention allows families flexibility through written materials and weekly guidance from a family coach, making it accessible and adaptable to different schedules. These innovative strategies could lead to more effective, holistic improvements in mental health and family relationships.

What evidence suggests that this trial's treatments could be effective for supporting mental health in families?

Research has shown that Parent-Child Interaction Therapy (PCIT), which participants in this trial may receive as part of the Parent-Child Intervention arm, improves children's behavior and reduces parental stress. Studies have found that PCIT benefits caregivers' mental health and decreases behavior problems in children, effectively managing disruptive behavior in young children.

Additionally, research indicates that psychoeducational family interventions, like the Self-study Intervention arm in this trial, greatly enhance family mental health. These programs lower stress and improve the well-being of both parents and children, reducing the likelihood of mental health issues returning. Both treatment options in this trial have demonstrated improvements in family communication and mental health. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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, 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]

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) 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]

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]

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]

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) 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5530857/

Parent–Child Interaction Therapy: current perspectives - PMC

Parent–Child Interaction Therapy (PCIT) is an evidence-based approach originally intended to treat disruptive behavior problems in children aged 2 to 7 years.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0145213422004768

Outcomes of Parent-Child Interaction Therapy (PCIT) for ...

Treatment outcomes include lower parenting stress, reduced recidivism of abuse, decreased problematic child behaviors, and improved caregiver mental health ( ...

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parentchildinteractiontherapy.com

parentchildinteractiontherapy.com/research-treatment-outcomes

Treatment Outcomes | Parent Child Interaction Therapy

Abstract: This study examined outcomes of Parent–Child Interaction Therapy (PCIT) for 52 clinically referred children with oppositional behavior and their ...

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journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0159845

Effectiveness of Parent-Child Interaction Therapy (PCIT) in the ...

The aim of the present investigation was to compare the effectiveness of Parent-Child Interaction Therapy (PCIT) with treatment as usual (TAU) in young ...

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psicothema.com

psicothema.com/pdf/4701.pdf

Meta-analysis of the Efficacy and Effectiveness of Parent ...

Behavioral outcomes of Parent-Child Interaction Therapy and Triple P-Positive Parenting Program: A review and meta-analysis. Journal of Abnormal Child ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10894622/

Randomized Trial of Parent–Child Interaction Therapy ...

This randomized trial presents the first evidence that PCIT improves inhibitory control and emotion regulation in a child welfare parents.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT01085305

The Effectiveness of Parent-Child Interaction Therapy (PCIT)

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

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cebc4cw.org

cebc4cw.org/program/parent-child-interaction-therapy/detailed

Parent Child Interaction Therapy › Program › Detailed

Parent-Child Interaction Therapy (PCIT) is a dyadic behavioral intervention for children (ages 2.0–7.0 years) and their parents or caregivers.