Spina Bifida Healthcare Navigator Program

Browse trials for

• Spinal Dysraphism 142
• Health Behavior 967
• Meningomyelocele 58

Keywords

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

Spinal Dysraphism

142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.

This study's planned enrollment of 24 is below the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Study 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

  Behavioral: Behavioral Treatment

• 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.

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.

  Also known as: Spina Bifida Healthcare Navigator Program

Primary outcomes

1. 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.

   Time frame: post-intervention (approximately two months after enrollment; administered only to participants assigned to the intervention group)

2. 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.

   Time frame: post-intervention (approximately two months after enrollment; administered only to participants assigned to the intervention group)

3. 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.

   Time frame: post-intervention (approximately two months after enrollment; administered only to participants assigned to the intervention group)

Secondary outcomes

1. 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.

   Time frame: Enrollment to approximately two months

2. 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.

   Time frame: Enrollment to approximately two months

3. 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.

   Time frame: Enrollment to approximately two months

4. 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.

   Time frame: Enrollment to approximately two months

5. 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.

   Time frame: Enrollment to approximately two months

6. 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.

   Time frame: Enrollment to approximately two months

7. 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.

   Time frame: Enrollment to approximately two months

8. 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.

   Time frame: Enrollment to approximately two months

9. 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.

   Time frame: Enrollment to approximately two months

10. 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.

    Time frame: Enrollment to approximately two months

Other outcomes

1. 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.

   Time frame: Enrollment to approximately two months

2. 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.

   Time frame: Enrollment to approximately two months

Individual participant data

Plan to share: No — 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.