Spina Bifida Healthcare Navigator Program (ALIGN)

Spina Bifida Healthcare Navigator Program: A Pilot Trial of the ALIGN Contextual-Behavioral Intervention

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spina Bifida
• Intervention / Treatment: Behavioral: Behavioral Treatment

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh/UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults (18 years or older) diagnosed with spina bifida (SB), including any type (e.g., myelomeningocele, meningocele, lipomyelomeningocele).
• Individuals who are able to participate in educational and interactive sessions (in-person at UPMC Mercy or remotely via secure teleconferencing).
• English fluency

Exclusion Criteria:

• Under 18 years of age
• Non-English fluency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.; Other Names: Spina Bifida Healthcare Navigator Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure (AIM)	This measure assesses perceived acceptability of an intervention. The scale consists of 4 items, each rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Scores are calculated as the mean of all items, yielding a score range of 1 to 5. Higher scores indicate greater perceived acceptability. No items are reverse scored.	post-intervention (approximately two months after enrollment; administered only to participants assigned to the intervention group)
Intervention Appropriateness Measure (IAM)	This measure assesses perceived appropriateness of an intervention, defined as its perceived fit, relevance, or compatibility for a given context or population. The scale consists of 4 items, each rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Scores are calculated as the mean of all items, yielding a score range of 1 to 5. Higher scores indicate greater perceived appropriateness. No items are reverse scored.	post-intervention (approximately two months after enrollment; administered only to participants assigned to the intervention group)
Feasibility of Intervention Measure (FIM)	This measure assesses perceived feasibility of implementing an intervention within a given setting. The scale consists of 4 items, each rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Scores are calculated as the mean of all items, yielding a score range of 1 to 5. Higher scores indicate greater perceived feasibility. No items are reverse scored.	post-intervention (approximately two months after enrollment; administered only to participants assigned to the intervention group)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PROMIS Depression Measure	This measure assesses severity of depressive symptoms, including affective and cognitive components of depression. Scores are reported as T-scores standardized to the U.S. general population (mean = 50, standard deviation = 10). Higher T-scores indicate greater depressive symptom severity. Scores are generated using PROMIS computer adaptive testing algorithms; raw item scores are not summed.	Enrollment to approximately two months
Change in Partners in Health (PIH) Scale	The PIH Scale assesses self-management capacity in individuals with chronic health conditions, including knowledge, treatment adherence, symptom monitoring, and management of physical, emotional, and social impacts. The scale includes 12 items, each rated from 0 to 8, producing a total score range of 0-96. Higher scores indicate greater self-management capacity. Item scores are summed to compute the total score; subscale scores (e.g., condition and treatment knowledge, coping, condition management, treatment adherence) may also be examined descriptively but are not required for total score computation.	Enrollment to approximately two months
Change in Acceptance and Action Questionnaire-2 (AAQ-2)	The AAQ-2 measures psychological inflexibility and experiential avoidance, core constructs within Acceptance and Commitment Therapy. The scale contains 7 items, each rated on a 7-point Likert scale (1-7), yielding a total score range of 7-49. Higher total scores indicate greater psychological inflexibility and experiential avoidance, whereas lower scores indicate greater psychological flexibility. Items are summed after required reverse scoring to produce the total score.	Enrollment to approximately two months
Change in PROMIS Self-Efficacy (Managing Daily Activities)	This measure assesses perceived confidence in performing various activities of daily living related to chronic health conditions, such as routine tasks, exercise, and managing activities in challenging situations. Scores are reported as T-scores standardized to a calibration population (mean = 50, standard deviation = 10). Higher T-scores indicate greater self-efficacy in managing daily activities. Scores are generated using PROMIS computer adaptive testing algorithms based on item response theory; raw item scores are not summed.	Enrollment to approximately two months
Change in PROMIS Participation Measure	This measure assesses perceived ability to participate in social roles and activities, including work, family, and community functioning. Scores are reported as T-scores standardized to the U.S. general population (mean = 50, standard deviation = 10). Higher T-scores indicate greater ability to participate in social roles and activities. Scores are generated using PROMIS computer adaptive testing algorithms based on item response theory; raw item scores are not summed.	Enrollment to approximately two months
Change in PROMIS Anxiety Measure	This measure assesses severity of anxiety symptoms, including fear, worry, and physiological arousal. Scores are reported as T-scores standardized to the U.S. general population (mean = 50, standard deviation = 10). Higher T-scores indicate greater anxiety symptom severity. Scores are generated using PROMIS computer adaptive testing algorithms; raw item scores are not summed.	Enrollment to approximately two months
Change in PROMIS Self-Efficacy (Managing Symptoms)	This measure assesses perceived confidence in the ability to manage and control symptoms associated with chronic health conditions across a variety of settings and situations. Scores are reported as T-scores standardized to a calibration population (mean = 50, standard deviation = 10). Higher T-scores indicate greater self-efficacy in managing symptoms. Scores are generated using PROMIS computer adaptive testing algorithms based on item response theory; raw item scores are not summed.	Enrollment to approximately two months
Change in PROMIS Self-Efficacy (Managing Medications and Treatments)	This measure assesses perceived confidence in managing medication regimens and treatment-related tasks associated with chronic health conditions, including adherence, scheduling, and navigating treatment decisions. Scores are reported as T-scores standardized to a calibration population (mean = 50, standard deviation = 10). Higher T-scores indicate greater self-efficacy in managing medications and treatments. Scores are generated using PROMIS computer adaptive testing algorithms based on item response theory; raw item scores are not summed.	Enrollment to approximately two months
Change in PROMIS Self-Efficacy (Managing Emotions)	This measure assesses perceived confidence in managing emotional responses related to living with chronic health conditions, including worry, frustration, and discouragement. Scores are reported as T-scores standardized to a calibration population (mean = 50, standard deviation = 10). Higher T-scores indicate greater self-efficacy in managing emotions. Scores are generated using PROMIS computer adaptive testing algorithms based on item response theory; raw item scores are not summed.	Enrollment to approximately two months
Change in PROMIS Self-Efficacy (Managing Social Interactions)	This measure assesses perceived confidence in managing social situations and interpersonal interactions related to living with chronic health conditions, including communicating needs and participating in social activities. Scores are reported as T-scores standardized to a calibration population (mean = 50, standard deviation = 10). Higher T-scores indicate greater self-efficacy in managing social interactions. Scores are generated using PROMIS computer adaptive testing algorithms based on item response theory; raw item scores are not summed.	Enrollment to approximately two months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Grit-12	The Grit-12 measures perseverance of effort and consistency of interests toward long-term goals. It contains 12 items rated on a 5-point Likert scale, producing a total score range of 1-5 when averaged. Higher scores indicate greater grit. Items are averaged after appropriate reverse scoring to compute the total score; subscale scores for perseverance and consistency may also be derived.	Enrollment to approximately two months
Change in Interpersonal Support Evaluation List-12 (ISEL-12)	The ISEL-12 assesses perceived availability of social support, including appraisal, belonging, and tangible support. The scale includes 12 items rated on a 4-point Likert scale, yielding a total score range of 12-48. Higher scores indicate greater perceived social support. Item scores are summed to produce the total score; subscale scores (e.g., appraisal, belonging, tangible support) can also be computed.	Enrollment to approximately two months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Fisa Foundation
• Investigators: Principal Investigator: Ted A Barrios, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: self-management; psychotherapy; neuropsychology; health behavior; spina bifida; cognitive-behavioral therapy; executive functioning; myelomeningocele; rehabilitation psychology
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Spinal Dysraphism; Meningomyelocele; Health Behavior; Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID Numbers: STUDY25050157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No. This study is a small, pilot, underpowered feasibility project designed to assess acceptability, feasibility, and preliminary signals rather than to support confirmatory hypothesis testing. The sample size and study design limit the reliability and generalizability of individual participant data for secondary analyses, and no formal data-sharing infrastructure or governance plan was established for this pilot. Aggregate results may be disseminated through scholarly publication, but individual participant-level data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No