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Spina Bifida Healthcare Navigator Program

NCT07531862 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-04

No results posted yet for this study

Summary

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.

Conditions

  • Spina Bifida

Interventions

BEHAVIORAL

Behavioral Treatment

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.

Sponsors & Collaborators

Principal Investigators

  • Ted A Barrios, PhD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2026-08-31
Completion
2026-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07531862 on ClinicalTrials.gov