Using the Theory of Change framework to map active ingredients and mechanisms of change underlying an early parent-implemented intervention for autism spectrum disorder

项目摘要 自闭症谱系障碍（ASD）是一种终身神经发育障碍，在美国每59名儿童中就有1名受到影响。 美国的早期干预对于改善这一人群的结果至关重要。一个成长中的早期 干预研究支持使用自然发展行为干预（NDBIs）， 整合发展和行为技术。关注照顾者参与早期干预导致 父母实施的NDBI（PI-NDBI）的发展，其中父母被教导提供NDBI 技术与他们的孩子。然而，需要更多的研究来了解如何最好地支持 家庭照顾者在促进孩子在家学习方面的作用。虽然PI-NDBI有越来越多的证据基础， 尽管这些复杂的干预措施能够改善儿童的成果，但尚未在社区环境中得到广泛采用。 这项研究的长期目标是为PI-NDBIs的优化提供信息，以最大限度地提高疗效， 使社区能够更广泛地实施，并支持有计划地调整这些干预措施， 社区设置。这些与NICHD的研究重点相一致，以促进发展， 传播和实施对发育障碍的治疗，这将影响临床 在社区环境中进行护理，提高生活质量。复合材料评价的新进展 干预措施强调混合方法的效用，以了解复杂的治疗方法 工作本研究的目的是使用混合方法来阐明潜在的活性成分， 相关机制的变化的经验支持的早期干预，解决核心赤字 的ASD。首先，与主要利益相关者的访谈和随后的定性分析将用于制定一个 全面的变化理论，描述了潜在的活性成分和变化机制 ImPACT项目是一个基于证据的PI-NDBI。这将阐明父级和提供商级因素 可能影响干预效果。接下来，将使用三角测量协议来整合理论和研究 来自利益相关者的数据。这些结果将在变革理论模型中可视化。最后我们 将通过使用以下档案数据测试选择的途径，提供变革理论的概念验证： ImPACT项目的干预试验。拟议的研究和多方面培训计划包括正在进行的 与干预和实施科学专家的指导，定性和混合方面的高级培训 方法研究，暴露于评价科学领域，监督临床经验和经验 让社区利益相关者参与研究。活性成分和相关机制的鉴定 改革的成果有可能最大限度地提高效力，简化干预措施， 有限的资源和对高保真治疗的最大需求。这将有助于解决长期 ASD早期社会沟通缺陷对公共卫生的影响。

PROJECT SUMMARY Autism spectrum disorder (ASD) is a lifelong neurodevelopmental disability that affects 1 in 59 children in the United States. Early intervention is crucial for improving outcomes in this population. A growing body of early intervention research supports the use of Naturalistic Developmental Behavioral Interventions (NDBIs), which integrate developmental and behavioral techniques. A focus on caregiver involvement in early intervention led to the development of parent-implemented NDBIs (PI-NDBIs), in which parents are taught to deliver NDBI techniques with their children. However, more research is needed to understand how best to support caregivers in promoting their children’s learning at home. While PI-NDBIs have a growing evidence base for improving child outcomes, these complex interventions have not been widely adopted in community settings. The long-term goal of this research is to inform the optimization of PI-NDBIs in order to maximize efficacy, enable more widespread community implementation, and support planned adaptation of these interventions in community settings. These align with NICHD research priorities to promote the development, dissemination, and implementation of treatments for developmental disabilities that will impact clinical care in community settings and improve quality of life. Recent advances in the evaluation of complex interventions emphasize the utility of mixed method approaches for understanding how complex treatments work. The study objective is to use a mixed methods approach to elucidate potential active ingredients and associated mechanisms of change of an empirically supported early intervention which addresses core deficits of ASD. First, interviews with key stakeholders and subsequent qualitative analysis will be used to develop a comprehensive Theory of Change describing the potential active ingredients and mechanisms of change underlying Project ImPACT, an evidence-based PI-NDBI. This will clarify how parent- and provider-level factors may impact intervention outcomes. Next, a triangulation protocol will be used to integrate theory and research evidence with data from stakeholders. These results will be visualized in a Theory of Change model. Last, we will provide proof-of-concept of the Theory of Change by testing select pathways using archival data from intervention trials of Project ImPACT. The proposed research and multifaceted training plan include ongoing mentorship with experts in intervention and implementation science, advanced training in qualitative and mixed methods research, exposure to the field of evaluation science, supervised clinical experience, and experience engaging community stakeholders in research. Identification of active ingredients and associated mechanisms of change has the potential to optimize effectiveness and streamline interventions to increase access for those with limited resources and the greatest need for high fidelity treatments. This would help address the long-term public health impacts of early social communication deficits in ASD.