MAPS for Family Caregivers of Children With Medical Complexity

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called MAPS (Meaning And Problem Solving), designed to support parents and family caregivers of children with complex health needs. The program focuses on improving caregivers' emotional well-being and boosting their confidence in facing challenges. Participants will either engage in the MAPS program, which includes eight one-on-one sessions, or continue with usual care. Family caregivers with medical decision-making power for a child with multiple chronic health issues and high healthcare needs may be suitable for this trial. As an unphased trial, it offers caregivers the chance to contribute to innovative support strategies that could enhance their well-being and confidence.

What prior data suggests that the MAPS program is safe for family caregivers?

A previous study demonstrated that the MAPS (Meaning And Problem Solving) program supports family caregivers of children with complex medical needs. Specific safety data for MAPS does not exist because it functions as a supportive program rather than a medical treatment. Since MAPS involves talking and problem-solving sessions, it is generally considered safe.

No evidence links any negative effects or safety concerns directly to MAPS sessions. Instead, the program aims to improve emotional well-being and coping skills, suggesting it is well-tolerated and focuses on providing emotional and social support. Participants in the MAPS program will have sessions with trained professionals, ensuring a guided and professional approach.

Overall, while specific safety data is lacking, the supportive nature of the MAPS program implies a low risk of negative effects.12345

Why are researchers excited about this trial?

Researchers are excited about the MAPS (Meaning And Problem Solving) intervention for family caregivers of children with medical complexity because it offers a personalized approach that goes beyond standard psychosocial care. Unlike usual care, which generally includes routine evaluations and support services, MAPS provides structured one-on-one sessions that focus on meaning-making and problem-solving skills, delivered either in-person or via videoconference. This tailored approach not only addresses caregivers' emotional and social needs but also equips them with practical strategies to manage the complex challenges they face, potentially improving their well-being more effectively.

What evidence suggests that the MAPS program is effective for supporting family caregivers of children with medical complexity?

Research has shown that caregivers of children with complex medical needs often face more mental health challenges than the general population, which can complicate their caregiving duties. In this trial, participants in the MAPS (Meaning and Problem Solving) intervention arm will attend sessions aimed at enhancing caregivers' emotional well-being and confidence in handling difficult situations. Studies have found that programs like MAPS can improve caregivers' mental health and quality of life. Although MAPS is a newer program, its emphasis on emotional support and problem-solving offers hope for families managing these challenging caregiving roles.12467

Who Is on the Research Team?

JA

Justin A Yu, MD, MSc

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for parents or family caregivers of children who have complex medical needs. Participants should be actively caring for such a child and willing to try a new support program.

Inclusion Criteria

Caregiver's child is medically complex, defined as one or more chronic health conditions, major functional limitations, significant health service needs, and high health care utilization
Family caregiver of a child or dependent adult with impaired capacity receiving medical care at UPMC Children's Hospital of Pittsburgh's Complex Care Center or Supportive Care team
I am authorized to make medical decisions for my child.

Exclusion Criteria

My caregiver is younger than 18 years old.
Caregiver unable to complete intervention sessions in English
Caregivers of children who do not live at home (i.e., reside in long-term nursing care facilities)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 one-on-one sessions with a trained MAPS interventionist over 2-3 months

8-12 weeks
8 visits (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MAPS (Meaning And Problem Solving)

Trial Overview

The study compares the MAPS (Meaning And Problem Solving) program, designed to help caregivers cope emotionally and solve problems, with usual psychosocial care. The goal is to see if MAPS helps improve caregiver well-being.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: MAPS InterventionExperimental Treatment1 Intervention
Group II: Usual Psychosocial CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Citations

Pilot Trial of a Meaning And Problem-Solving (MAPS) ...

This study aims to evaluate a new program specifically developed to better support parents and family caregivers of children with complex ...

Self-Reported Well-Being of Family Caregivers of Children ...

Compared to US population norms, caregivers of CMC (n = 143) reported significantly lower global mental health and emotional regulation ability

Interventions in the Home and Community for Medically ...

This systematic review aims to synthesize the existing literature describing interventions in the home and community that include caregivers of ...

Quality of Life and Mental Health Among Families Caring ...

Background: Families caring for children with medical complexity (CMC) face sustained psychosocial demands that may impair health-related quality of life ...

Home Health Care Research for Children With Disability ...

In this paper, we review the recent literature in pediatric home health care and then propose an actional agenda that could address its missing ...

Family Caregivers' Experiences of Services for Children With ...

Objectives: To systematically identify and synthesise the qualitative evidence of family caregivers' experiences of health, care and education ...

Children with Medical Complexity and Their Families

Children with medical complexity and their families navigate a labyrinth of medical, social, and financial challenges, often bearing an ...