Empowered Relief for Caregivers
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Empowered Relief for Caregivers (ER-CY).
- Кому может быть актуально
- Состояния в реестре: Chronic Pain, Musculoskeletal Pain, Fibromyalgia, Neuropathic Pain. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Empowered Relief for Caregivers (ER-CY): A Co-Designed Brief Intervention to Support Families of Youth With Chronic Pain
Обзор
This study is testing a new program called Empowered Relief for Caregivers (ER-CY), designed to support caregivers of children and teens who live with chronic pain. ER-CY is a single two-hour class delivered online. It teaches skills for managing the stress of caring for a child in pain and for responding to a child's pain in helpful ways. Up to 80 caregivers of youth with chronic pain will take part in one ER-CY class and then complete surveys and a short interview over the following three months. The researchers want to learn two things: whether caregivers are willing and able to take part and find the program helpful and satisfying, and whether the program lowers caregiver distress and improves their child's day-to-day functioning. What is learned will help guide future programs and care for youth with chronic pain and their families.
Подробное описание
Background and Rationale: Chronic pain is common in youth and is associated with significant long-term physical and mental health consequences, yet it remains under-recognized and undertreated. Cognitive behavioral therapy (CBT) is an effective treatment, but access barriers limit its reach, leaving a gap for scalable, accessible interventions. Empowered Relief (ER) is a single-session, skills-based intervention that has produced outcomes comparable to multi-session CBT in adults; a youth adaptation (ER-Y) has shown strong feasibility, acceptability, and effectiveness. At the same time, caregiver distress, including anxiety and depressive symptoms, is associated with worse child pain outcomes, but few brief, accessible interventions exist to support caregivers themselves. To address this gap, the investigators co-designed Empowered Relief for Caregivers (ER-CY), a brief virtual intervention for caregivers of youth with chronic pain, and designed this study to evaluate its feasibility, acceptability, and preliminary effectiveness.
Objectives: The study has two aims. Aim 1 is to assess the feasibility and acceptability of ER-CY, indexed by participant attendance and ratings of credibility and satisfaction. Aim 2 is to evaluate preliminary effectiveness, indexed by caregiver distress, caregiver behavior in response to their child's pain, and parent-reported youth pain interference. The investigators hypothesize that ER-CY will demonstrate strong feasibility and acceptability and that caregivers will show reduced distress and reduced unhelpful responses to pain, along with improvements in youth pain-related functioning over time.
Design and Procedures: This is a single-group study enrolling up to 80 caregivers of youth with chronic pain, conducted at the Pediatric Pain Management Clinic at Stanford Medicine Children's Health. Caregivers identified through the clinic complete an eligibility questionnaire, a screening call, and informed consent, and then complete baseline surveys via REDCap. Participants attend one approximately two-hour ER-CY class delivered virtually via Zoom and complete post-class surveys immediately afterward. Within one to two weeks, participants complete a semi-structured qualitative interview, which is audio- and video-recorded for analysis. Outcome and monitoring assessments are repeated at 1, 2, and 3 months following the intervention. Changes over time will be examined using mixed-effects models, and no interim analysis is planned.
Вмешательства
- Поведенческое Empowered Relief for Caregivers (ER-CY)
Empowered Relief for Caregivers is a single-session, skills-based behavioral intervention delivered virtually via Zoom in one session of approximately two hours. Co-designed with caregivers, it adapts the Empowered Relief approach for caregivers of youth with chronic pain, teaching strategies to reduce caregiver distress and to respond more adaptively to a child's pain. All participants receive the same single class; there are no additional sessions or booster components.
Первичные конечные точки
- Treatment Expectancy and Credibility: Caregiver Version [Срок оценки: Immediately post class]
- Program Feedback Scale [Срок оценки: Immediately post class]
- Exit Interview [Срок оценки: 1-2 weeks post class]
Вторичные конечные точки (9)
- Adult Responses to Children's Symptoms (ARCS) - Protect Subscale [Срок оценки: Pre-class, 1 month, 2 months, and 3 months post class]
- Bath Adolescent Pain Parental Impact Questionnaire [Срок оценки: Pre-class, 1 month, 2 months, and 3 months post class]
- Child Activity Limitations Interview-9 [Срок оценки: Pre-class, 1 month, 2 months, and 3 months post class]
- Generalized Anxiety Disorder-2 [Срок оценки: Pre-class, 1 month, 2 months, and 3 months post class]
- Pain Catastrophizing Scale - Parent [Срок оценки: Pre-class, 1 month, 2 months, and 3 months post class]
- Pain Catastrophizing Scale [Срок оценки: Pre-class, 1 month, 2 months, and 3 months post class]
- Patient Health Questionnaire-2 [Срок оценки: Pre-class, 1 month, 2 months, and 3 months post class]
- Parent Psychological Flexibility Questionnaire - 10 [Срок оценки: Pre-class, 1 month, 2 months, and 3 months post class]
- Parent Risk and Impact Screening Measure - 12 [Срок оценки: Pre-class, 1 month, 2 months, and 3 months post class]
Критерии участия
Критерии включения
- Caregiver of a youth with a chronic pain diagnosis (>3 months in duration)
- English speaking
Критерии исключения
- Significant psychosocial complexity based on clinical team assessment (e.g., severe depression/anxiety, unable to tolerate a group setting)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Stanford University — Palo Alto
Идентификаторы
NCT: NCT07636980 · 86875