Spina Bifida Healthcare Navigator Program

NCT07531862 | Not Yet Recruiting

• 1 other identifier: STUDY25050157
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

spina bifida; executive functioning; neuropsychology; rehabilitation psychology; health behavior; psychotherapy; cognitive-behavioral therapy; myelomeningocele; self-management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Change in PROMIS Depression Measure

  Enrollment to approximately two months

• Change in Partners in Health (PIH) Scale

  Enrollment to approximately two months

• Change in Acceptance and Action Questionnaire-2 (AAQ-2)

  Enrollment to approximately two months

• Change in PROMIS Self-Efficacy (Managing Daily Activities)

  Enrollment to approximately two months

• Change in PROMIS Participation Measure

  Enrollment to approximately two months

Other Outcomes (2)

• Change in Grit-12

  Enrollment to approximately two months

• Change in Interpersonal Support Evaluation List-12 (ISEL-12)

  Enrollment to approximately two months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants in this arm will participate in a waitlist control condition. Data will collected at a time interval that approximates the intervention arm.

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.

Also known as: Spina Bifida Healthcare Navigator Program

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under 18 years of age
• Non-English fluency

Sponsors & Collaborators

• University of Pittsburgh: lead
• Fisa Foundation: collaborator

Study Sites (1)

University of Pittsburgh/UPMC

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Spinal Dysraphism; Health Behavior; Meningomyelocele

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ted A Barrios, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Wilcox

CONTACT

(412) 491-7037; kesslerl@upmc.edu

Ted A Barrios, PhD

CONTACT

(412) 232-4301; TAB360@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a preliminary, pilot study with an intervention group and waitlist control group. Data will be collected pre-/post- for intervention group participants and at a similar time interval for control group participants. The goal of this study is to assess basic feasibility, acceptability, and preliminary signs of promise to support larger, more robust trials.

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)