Pilot Trial of a Meaning And Problem-Solving (MAPS) Intervention for Family Caregivers of Children With Medical Complexity

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07876206
Status
Not Yet Recruiting

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Conditions

  • Children With Medical Complexity (CMC)
  • Family Caregivers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MAPS (Meaning And Problem Solving) — BEHAVIORAL
    The MAPS intervention is a manualized behavioral program, tailored for family caregivers of children with medical complexity, which consists of 8 one-on-one 45-60 minute sessions delivered by a trained interventionist. The intervention aims to improve participant mental health and emotional well-being by enhancing participants' sense of meaning and problem-solving skills. Key components adapted from meaning-centered psychotherapy include: identifying sources of meaning, guided imagery, personalized coping statements, meaningful activity scheduling, and values-based goal setting. Problem-solving skills-training is adapted from Bright IDEAS, a 5-step framework to teach problem-solving skills originally developed for mothers of children with cancer. Participants receive a workbook with reference materials, worksheets, and home practice exercises to promote skill mastery and routine maintenance.
  • Usual Psychosocial Care — BEHAVIORAL
    Participants randomized to the comparison arm will receive usual psychosocial care services routinely provided by our institution's pediatric complex care and palliative care interdisciplinary team. This psychosocial care includes routine clinical evaluations, emotional and social support, and care coordination services, which are delivered via scheduled outpatient clinic visits, phone/virtual consultations, or inpatient visits.

Study Details

This study aims to evaluate a new program specifically developed to better support parents and family caregivers of children with complex health needs. The name of this program is MAPS (Meaning and Problem Solving). The goal of MAPS is to improve caregivers' emotional well-being and confidence in dealing with adversity. We are testing the program to see if parents and family caregivers find the MAPS program acceptable and identify ways we can improve it.

Key Dates

First listed
Oct 15, 2026
Start date
Jan 31, 2027
Status verified
Oct 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: MAPS Intervention
    Participants randomized to this experimental arm will undergo 8 one-on-one sessions with a trained MAPS interventionist over 2-3 months. Sessions can be conducted in-person or via videoconference (per participant preference); and will last 45- to 60-minutes in duration.
  • Active Comparator: Usual Psychosocial Care
    Participants randomized to the comparison arm will receive usual psychosocial care services routinely provided by our institution's pediatric complex care and palliative care interdisciplinary team. This psychosocial care includes routine clinical evaluations, emotional and social support, and care coordination services, which are delivered via scheduled outpatient clinic visits, phone/virtual consultations, or inpatient visits.

Primary Outcome Measure

Feasibility: Recruitment Rate [ Time Frame: Approach-to-Consent: from initial approach to 12 weeks after initial approach. Consent-to-Enroll: 12 weeks from obtaining written informed consent . ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224
Justin Yu, MD, MSc
[email protected]
2157388265
Roxanne Jones
[email protected]

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By research site
UPMC Children's Hospital of Pittsburgh· Pittsburgh, PA

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