Early Test of an Innovative Child Maltreatment (CM) Prevention Strategy
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Technology Enhanced Implementation Package, SafeCare.
- Кому может быть актуально
- Состояния в реестре: Parenting Intervention, Maltreatment, Prevention. 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Pilot Test of an Innovative Implementation Strategy to Improve Reach, Quality, and Equity in Child Maltreatment Prevention
Обзор
Millions of children are victims of maltreatment each year in the United States. Research on home visiting programs show that child maltreatment can be prevented; however, these programs struggle to reach families in need and provide high quality care. SafeCare is a sustainable and effective home visiting child maltreatment prevention program, serving over 8,000 families each year. This study will examine the feasibility and implementation of a hybrid in-person/virtual delivery model for SafeCare with 12 home visiting providers and 40 caregivers to inform how home visiting programs are delivered to maximize reach to families, improve family outcomes, and decrease harm to children.
Подробное описание
Child maltreatment (CM) is a public health priority, affecting millions of children each year. Evidence-based home visiting (HV) models are gold standard CM prevention programs that intervene on modifiable risk factors. Despite their effectiveness and national implementation, HV is resource intensive which limits their potential reach and impact. HV programs serve only 3% of high-risk families, with limited access for minoritized and rural-dwelling families. Rigorous research is needed to guide approaches to implementing HV to ensure agencies can deliver the highest-quality care with more accessibility and equity without compromising child safety. Preliminary data during the COVID-19 pandemic offered insight to the benefits of virtual, telehealth-based visits for CM prevention and enabled service agencies to observe that quality and safety concerns can be managed in most cases. The consensus of experts and HV providers is that hybrid, telehealth leveraged HV implementation can enhance access, quality, and efficiency of CM prevention models. Moreover, technology-based supports are needed to engage families, drive skill acquisition, support model fidelity, and improve accuracy in safety and skill assessment. Through an institutional KL2 award (PI: Espeleta), leveraging community advisory boards, secondary data analysis of clinical services data, and user-centered design methods, I am developing a telehealth-compatible, technology-enhanced, hybrid in-person/virtual implementation package for CM prevention. This package will consist of protocol adaptations, evidence-informed guidelines, and digital health resources to improve implementation outcomes related to reach, quality, and equity. However, the KL2 does not include a pilot RCT, which is essential to establish the feasibility of the implementation package as well as the RCT methodology in preparation for a future R01. The project's goals are to 1) Refine and preliminarily evaluate the TEIP and the feasibility of the research methodology with 12 providers and 40 families; and 2) Assess implementation factors related to the TEIP including its usability, acceptability, and feasibility with key constituents. Findings will inform a future R01 submission to evaluate the hybrid HV/virtual implementation on dimensions of equitable reach, effectiveness, implementation, and maintenance.
Вмешательства
- Другое Technology Enhanced Implementation Package
The Technology Enhanced Implementation Package for SafeCare delivery consists of protocol adaptations, evidence-informed guidelines, and digital health resources to improve SafeCare outcomes related to reach, quality, and equity. - Другое SafeCare
SafeCare is an evidence-based home visiting parenting program with three modules focused on child health, home safety, and parent-child relationships. SafeCare sessions typically occur weekly over 18 weeks.
Первичные конечные точки
- SafeCare Sick or Injured Child Checklist [Срок оценки: From the enrollment to the end the Health module, ~6 weeks after starting Health module]
- Child Planned Activities Training Checklist [Срок оценки: From the enrollment to the end the Parent Child Interaction module, ~6 weeks after starting Parent Child module]
- SafeCare Home Observation Checklist [Срок оценки: From the enrollment to the end the Safety module, ~6 weeks after starting Safety module]
- Brief Child Abuse Potential Inventory [Срок оценки: Baseline, 3- and 6-month follow up]
- Children Services Involvement [Срок оценки: Baseline, 3- and 6-month follow up]
Вторичные конечные точки (12)
- Parent-Child Conflict Tactics Scale [Срок оценки: Baseline, 3-month and 6-month follow up]
- Parenting Stress Inventory [Срок оценки: Baseline, 3-month and 6-month follow up]
- Brief Symptom Inventory [Срок оценки: Baseline, 3-month and 6-month follow up]
- Patient Health Questionnaire [Срок оценки: Baseline, 3-month and 6-month follow up]
- NIDA Quick Screen [Срок оценки: Baseline, 3-month and 6-month follow up]
- Social Provisions Scale [Срок оценки: Baseline, 3-month and 6-month follow up]
- Protective Factors Survey [Срок оценки: Baseline, 3-month and 6-month follow up]
- Family Resource Scale [Срок оценки: Baseline, 3-month and 6-month follow up]
- The Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening Tool [Срок оценки: Baseline, 3-month and 6-month follow up]
- Client Satisfaction Survey [Срок оценки: 3-month follow up]
- Client Cultural Competency Inventory [Срок оценки: 3-month follow up]
- Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure [Срок оценки: 3-month follow up]
Критерии участия
Критерии включения
- At least 18 years old
- English language proficiency
- Ability to provide informed consent for themselves
- Has at least one child between the ages of 0-5 years old - Caregivers Only
- Has completed at least 1 module of SafeCare since April 2021 - Caregivers Only
- SafeCare enrollment has been completed (e.g., not currently enrolled in SafeCare). - Caregivers Only
- Current employment at a SafeCare agency - Agency Leaders Only
- Full- or part-time employment at a SafeCare agency - Providers Only
- Must be fully certified to provide SafeCare services - Providers Only
- Must be providing services for at least 6 months - Providers Only
Критерии исключения
- Evidence of significant cognitive disability, developmental delay, or pervasive developmental disorder that would prohibit capacity to consent for themselves - Caregivers Only
- There are no primary exclusion criteria for the Providers.
- There are no primary exclusion criteria for Agency Leaders.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06912685 · Pro00141218