Family-Centered Implementation of Parent Training for Emotion Regulation in Autistic Toddlers Within the Part C Early Intervention System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Parent Training Treatment Acceptability
研究概览
简要总结
Early Intervention (EI) systems are ill-equipped to serve the many children 12 to 36 months with early signs or a diagnosis of autism spectrum disorder (ASD). EI funded by Part C of the Individuals with Disabilities Education Act (IDEA) uses home-based service delivery, emphasizes family-centered care, and prioritizes family-defined concerns (i.e., patient-centered outcomes). The Part C system is ideally situated to provide family-based intervention to children aged birth to three. However, Part C EI providers receive little training in ASD or the challenges characterizing ASD in toddlerhood, most notably emotion regulation. This study introduces Parent Training for emotion regulation for autistic toddlers into the Part C EI system, determines its feasibility and preliminary efficacy in this setting, and assesses what family, provider, and system-level factors may facilitate the uptake of parent training in the Part C EI system.
详细描述
Early Intervention (EI) systems are ill-equipped to serve the many children 12 to 36 months with early signs or a diagnosis of autism spectrum disorder (ASD). EI funded by Part C of the Individuals with Disabilities Education Act (IDEA) uses home-based service delivery, emphasizes family-centered care, and prioritizes family-defined concerns (i.e., patient-centered outcomes). The Part C system is ideally situated to provide family-based intervention to children aged birth to three. However, Part C EI providers receive little training in ASD or the challenges characterizing ASD in toddlerhood, most notably emotion regulation.
Emotion dysregulation, as indexed by frequent or unpredictable challenging behavior such as meltdowns and aggression, is a common family concern and a prominent aspect of ASD in toddlerhood. At least 50% of children with ASD exhibit challenging behavior, double the rate than in typically developing children. Challenging behavior can limit children's social and daily inclusion, predict later mental health challenges, and may weaken the efficacy of evidence-based early intervention. Challenging behavior is often misdiagnosed and over-pathologized in some children, who may therefore not be able to access evidence-based practices (EBPs) and services for autism and emotion dysregulation.
Parent Training is a collection of behavioral strategies (e.g., identifying antecedents, differential reinforcement, and teaching a replacement skill1) to help families reduce challenging behavior and improve emotion regulation in autism. Parent Training programs have demonstrated efficacy for autistic children across decades of research. However, Parent Training has not been implemented in Part C with toddlers with autism with the goal of fitting with families' values and Part C system constraints (Aim 1).
The successful implementation of Parent Training, like any evidence-based practice, relies not only on high family and provider acceptability, but also good fit with system and organizational characteristics. This study leverages new causal theory to mechanistically understand whether family and provider readiness (Aim 2), and system level characteristics (Aim 3) may enhance high quality Parent Training within Part C.
The objective of this K23 career development grant is to become an independent implementation scientist focused on autism services. Building on my training as a clinical scientist, I will learn to: use implementation methods that foster healthcare access; adapt interventions; explore mechanisms of both effectiveness and implementation; and evaluate system-level aspects of sustainable implementation. To enhance these goals, I propose a study that introduces Parent Training for emotion regulation in autism into the Part C EI system and determines its feasibility in this setting. The specific aims of this study are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The following is a list of inclusion and
排除标准
- •by participant group across all three research aims.
- •Inclusion Criteria for All Participants:
- •Able to provide written and informed consent;
- •Both sexes and all racial and ethnic origins;
- •English fluency (necessary for informed consent and measure completion)
- •Inclusion Criteria for Providers:
- •Is between 18 and 75 years of age
- •Holds a contract with or formally employed by BabyNet
- •Provides services within BabyNet at least one half-hour per week
- •Provides therapeutic services within BabyNet to at least one child 12-36 months who is 1) at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI, and 2) has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.
- •Exclusion Criteria for Providers:
- •Not contracted or employed by BabyNet
- •Provides services less than one half-hour per week
- •Does not provide services to a child 12-36 months of age at high-likelihood for ASD and with elevated emotion dysregulation (based on the POSI and the EDI-YC)
- •Inclusion Criteria for Caregiver in Caregiver-Child Dyad:
- •Is between 18 and 75 years of age
- •Is the legal guardian of the participating child
- •Child is receiving services within BabyNet at least one half-hour per week - Caregiver participates or is present for BabyNet services
- •Exclusion Criteria for Caregiver in Caregiver-Child Dyad:
- •Not between 18 and 75 years of age
- •Not the legal guardian of the child
- •Not able to be present for BabyNet services
- •Inclusion Criteria for Children in Caregiver-Child Dyad:
- •Is between 12 and 36 months of age
- •Is enrolled in BabyNet services at least one half-hour per week
- •Is considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI
- •Has elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.
- •Exclusion Criteria for Children in Caregiver-Child Dyad:
- •Is not between 12 and 36 months of age
- •Is not receiving services in BabyNet at least one half-hour per week
- •Is not considered to be at high-likelihood for ASD based on caregiver or provider concern for social communication delays and a positive screen on the POSI
- •Does not have elevated emotion dysregulation based on a raw score of at least 15 on the EDI-YC Reactivity Index.
研究组 & 干预措施
EI Practice-As-Usual (PAU)
The EI practice-as-usual group will receive their typical services listed on their Individualized Family Service Plan (IFSP) within their IDEA Part-C funded early intervention sessions.
Parent Training
Participants in the Parent Training group will receive a form of behavioral parent training as described in the "Manage Your Child's Challenging Behavior" module of Project ImPACT.
干预措施: Parent Training (Behavioral)
结局指标
主要结局
Parent Training Treatment Acceptability
时间窗: 8 weeks after the start of intervention (1-3 weeks post intervention)
Participants receiving Parent Training will complete an 18-item measure of treatment acceptability adapted from the Scale of Treatment Perceptions (STP; Berger et al., 2016). Treatment acceptability comprises how effective a participant views an intervention to be, as well as how feasible, acceptable, and appropriate it is. A composite average score will be calculated, and additional availability domains include "effectiveness", "family fit," and "negative aspects" of the intervention. Participants will rate each item on a Likert scale (1 = Strongly Disagree; 7 = Strongly Agree). A higher score (maximum = 7; minimum = 1) indicates greater treatment acceptability.
次要结局
- Parent Training Fidelity(Weekly up to 8 weeks)
- Parent Training Family Fit(8 weeks after the start of intervention (1-3 weeks post intervention))
- Parent Training Readiness(Weekly up to 8 weeks)
- Child Emotion Regulation(8 weeks after the start of intervention (1-3 weeks post intervention))
- Caregiver Stress(8 weeks after the start of intervention (1-3 weeks post intervention))
- Caregiver Self-Efficacy(8 weeks after the start of intervention (1-3 weeks post intervention))
研究者
Sarah Rose Edmunds
Assistant Professor of Psychology
University of South Carolina