Spina Bifida Healthcare Navigator Program: A Pilot Trial of the ALIGN Contextual-Behavioral Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Acceptability of Intervention Measure (AIM)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Under 18 years of age
- •Non-English fluency
研究组 & 干预措施
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
干预措施: Behavioral Treatment (Behavioral)
Control
Participants in this arm will participate in a waitlist control condition. Data will collected at a time interval that approximates the intervention arm.
结局指标
主要结局
Acceptability of Intervention Measure (AIM)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
- Change in PROMIS Anxiety Measure(Enrollment to approximately two months)
- Change in PROMIS Self-Efficacy (Managing Symptoms)(Enrollment to approximately two months)
- Change in PROMIS Self-Efficacy (Managing Medications and Treatments)(Enrollment to approximately two months)
- Change in PROMIS Self-Efficacy (Managing Emotions)(Enrollment to approximately two months)
- Change in PROMIS Self-Efficacy (Managing Social Interactions)(Enrollment to approximately two months)
研究者
Ted Allaire Barrios
Assistant Professor
University of Pittsburgh