Spina Bifida Healthcare Navigator Program

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07531862
Status
Active Not Recruiting

Conditions

  • Spina Bifida

Eligibility Criteria

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

Interventions

  • Behavioral Treatment — BEHAVIORAL
    The intervention being tested in this study (ALIGN) is designed to improve the fit between an individual's abilities and their environment. This is accomplished through two complementary approaches: building personal skills and strategies ("build"), and arranging supports and routines to make demands more manageable ("scaffold"). ALIGN includes six virtual group sessions and one individual session with a clinician. The intervention fits within the broad umbrella of "third-wave" cognitive-behavioral therapies. It emphasizes psychological flexibility as an important treatment component.

Study Details

Many adults with spina bifida experience difficulties managing their health-such as coordinating care across multiple providers, keeping up with medications, and navigating insurance systems. These tasks require strong thinking skills like planning, organizing, and problem-solving, which are often called "executive functions." Many adults with spina bifida have challenges with these skills due to differences in brain development associated with the condition. When a person's thinking abilities do not match the demands placed on them by their healthcare and daily routines, health problems often follow. Despite this, very few programs exist to help adults with spina bifida address this gap. This study tests a new program called ALIGN (Navigating Life with Spina Bifida), developed at the UPMC Adult Spina Bifida Clinic. ALIGN was co-designed with a healthcare provider who is also an adult living with spina bifida. The program helps participants improve the fit between their abilities and their environment through two approaches: building personal skills and strategies, and arranging supports and routines to make demands more manageable. ALIGN includes six virtual group sessions and one individual session with a clinician. Participants will be adults (age 18 or older) with spina bifida. They will complete questionnaires before and after the program measuring confidence in managing health, mood, and ability to participate in daily activities. A separate group of participants who do not take part in ALIGN will complete the same questionnaires for comparison. The main goals are to determine whether ALIGN is practical to deliver, acceptable to participants, and associated with early signs of benefit.

Key Dates

Start date
Apr 15, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention
    Participants in this arm will engage in the experimental intervention (ALIGN), which is a six-session, group-based cognitive-behavioral therapy program that is followed by a seventh, individual coaching session with a study clinician. Relevant data will be collected pre-/post-intervention
  • No Intervention: Control
    Participants in this arm will participate in a waitlist control condition. Data will collected at a time interval that approximates the intervention arm.

Primary Outcome Measure

Acceptability of Intervention Measure (AIM) [ Time Frame: post-intervention (approximately two months after enrollment; administered only to participants assigned to the intervention group) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh/UPMCPittsburghPennsylvania15219-

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University of Pittsburgh/UPMC· Pittsburgh, PA

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