Spina Bifida
Conditions
Keywords
spina bifida, executive functioning, neuropsychology, rehabilitation psychology, health behavior, psychotherapy, cognitive-behavioral therapy, myelomeningocele, self-management
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.
Interventions
BEHAVIORALBehavioral 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
University of Pittsburgh
Fisa Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention Measure (AIM) | post-intervention (approximately two months after enrollment; administered only to participants assigned to the intervention group) | 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. |
| Intervention Appropriateness Measure (IAM) | post-intervention (approximately two months after enrollment; administered only to participants assigned to the intervention group) | 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. |
| Feasibility of Intervention Measure (FIM) | post-intervention (approximately two months after enrollment; administered only to participants assigned to the intervention group) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS Depression Measure | Enrollment to approximately two months | 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. |
| Change in Partners in Health (PIH) Scale | Enrollment to approximately two months | 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. |
| Change in Acceptance and Action Questionnaire-2 (AAQ-2) | Enrollment to approximately two months | 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. |
| Change in PROMIS Self-Efficacy (Managing Daily Activities) | Enrollment to approximately two months | 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. |
| Change in PROMIS Participation Measure | Enrollment to approximately two months | 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. |
| Change in PROMIS Anxiety Measure | Enrollment to approximately two months | 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. |
| Change in PROMIS Self-Efficacy (Managing Symptoms) | Enrollment to approximately two months | 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. |
| Change in PROMIS Self-Efficacy (Managing Medications and Treatments) | Enrollment to approximately two months | 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. |
| Change in PROMIS Self-Efficacy (Managing Emotions) | Enrollment to approximately two months | 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. |
| Change in PROMIS Self-Efficacy (Managing Social Interactions) | Enrollment to approximately two months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTed A Barrios, PhD
University of Pittsburgh
Outcome results
None listed