Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,269
- 试验地点
- 1
- 主要终点
- Family Outcomes Survey - Revised
研究概览
简要总结
This study is testing three ways to deliver Early Intervention (EI) services for toddlers with developmental disabilities (DD).
Children enrolled in EI speech therapy will receive one of three approaches:
- Therapist Delivered EI: For 28 weeks, the child's speech therapist will work directly with the child to support their communication.
- Caregiver Coaching EI: For 28 weeks, the child's speech therapist will coach the caregiver on how to support their child's communication.
- Combined EI Approach + Parent-Led Education Program: For 14 weeks, the caregiver will take part in a parent-led education program while the speech therapist works directly with the child to support their communication. During the next 14 weeks, the speech therapist will coach the caregiver on how to support their child's communication.
The goal of this study is to identify which approaches are most effective so that all families can benefit fully from EI services.
详细描述
High-quality Early Intervention (EI) during the first three years of life, a period of heightened neuroplasticity, is critical to improving outcomes for children with developmental disabilities (DD). There are two EI approaches that may be effective for supporting child communication and improving family outcomes: 1) caregiver coaching, in which the EI therapist teaches the caregiver strategies to help their child's communication, and 2) caregiver psychoeducation, in which a peer mentor teaches the caregiver about skills and resources that are helpful in supporting their child and family.
The aim of the current clinical trial is to determine which EI approaches are most effective, for which families, and why they are effective. This clinical trial also aims to investigate how therapists are delivering the interventions and to characterize the acceptability and feasibility of these interventions for use in real-world settings.
A total of 1,269 toddlers (approximately equal numbers of Black, Latine, and white children) will be enrolled across community-based EI sites. Families will be directly recruited from participating EI therapists' existing caseloads. Caregiver-child dyads will be randomly assigned to one of three groups:
- Therapist Delivered EI: For 28 weeks, the child's speech therapist will work directly with the child to support their communication.
- Caregiver Coaching EI: For 28 weeks, the child's speech therapist will coach the caregiver on how to support their child's communication.
- Combined EI Approach + Parents Taking Action: For 14 weeks, the caregiver will take part in a parent-led education program (Parents Taking Action) while the speech therapist works directly with the child to support their communication. During the next 14 weeks, the speech therapist will coach the caregiver on how to support their child's communication.
Outcomes will assess both caregiver and child domains, including caregiver use of responsive strategies, caregiver capacity to support the child's needs, and child social communication. The study will also examine moderators (e.g., race) and mediators (e.g., caregiver use of responsive strategies) to identify for whom and why each approach is most effective.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 31 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child Inclusion Criteria:
- •At least 12 months old
- •At least 7 months of Early Intervention (EI) service eligibility remaining
- •Enrolled in the Illinois EI system and is new to the speech-language pathologist's (SLP's) caseload (i.e., no prior EI speech-language therapy experience with the SLP)
- •Plans to receive one hour of speech-language therapy per week in the home or in a private space outside of the home
排除标准
- •- Exposed to a language other than English or Spanish more than 10% of the time
- •Caregiver Inclusion Criteria:
- •The child's parent, legal guardian, or other family member
- •Self-identifies as Black, Latine (Hispanic), or white
- •Available to participate in weekly EI sessions and study assessments.
- •Caregiver Exclusion Criteria
- •Younger than 18 years old at enrollment
- •Uses a language other than English or Spanish during their interactions with the child more than 10% of the time
研究组 & 干预措施
Caregiver Coaching Early Intervention Approach
For 28 weeks, this arm will receive the caregiver coaching early intervention approach.
干预措施: Caregiver Coaching Early Intervention Approach (Behavioral)
Therapist-Delivered Early Intervention Approach
For 28 weeks, this arm will receive the therapist-delivered early intervention approach.
干预措施: Therapist-Delivered Early Intervention Approach (Behavioral)
Combined Early Intervention Approach + Parents Taking Action
For the first 14 weeks, this arm will receive the therapist-delivered early intervention as well as Parents Taking Action. For the following 14 weeks, this arm will receive the caregiver coaching early intervention approach.
干预措施: Parents Taking Action (Behavioral)
Combined Early Intervention Approach + Parents Taking Action
For the first 14 weeks, this arm will receive the therapist-delivered early intervention as well as Parents Taking Action. For the following 14 weeks, this arm will receive the caregiver coaching early intervention approach.
干预措施: Therapist-Delivered Early Intervention Approach (Behavioral)
Combined Early Intervention Approach + Parents Taking Action
For the first 14 weeks, this arm will receive the therapist-delivered early intervention as well as Parents Taking Action. For the following 14 weeks, this arm will receive the caregiver coaching early intervention approach.
干预措施: Caregiver Coaching Early Intervention Approach (Behavioral)
结局指标
主要结局
Family Outcomes Survey - Revised
时间窗: Week 14, Week 28
The Family Outcomes Survey-Revised is a 24-item informant-report questionnaire that assesses caregivers' understanding, confidence, and ability to support their child's needs. The Family Outcomes Total Score (Min = 24, Max = 120) reflects the caregiver's capacity to support their child's needs, with higher scores indicating greater capacity.
Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)
时间窗: Week 28
The Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP) is a structured, norm-referenced, observational measure of child communication. The assessment is scored for 20 items across 7 domains (i.e., Emotion and Eye Gaze, Communication, Gestures, Sounds, Words, Understanding, Object Use). The weighted raw scores for each of the 7 domains are grouped into 3 clusters (social, speech, and symbolic) and combined into a total raw score (min = 0; max = 113). Higher scores indicate better skills.
Responsive Strategy Use (RSU) Rating Scale
时间窗: Week 14, Week 28
The Responsive Strategy Use (RSU) Rating Scale will be used to measure caregivers' use of responsive strategies during a naturalistic, caregiver-child interaction. Items on the RSU Rating Scale are rated on a 4-point Likert Scale (0 = Rarely/Never, 3 = Consistently) and averaged to yield the RSU Total Score (Min = 0, Max = 3), with higher scores reflecting a higher frequency of responsive strategy use.
Family Outcomes Survey - Revised
时间窗: Week 14, Week 28
The Family Outcomes Survey-Revised is a 24-item informant-report questionnaire that assesses caregivers' understanding, confidence, and ability to support their child's needs. The Family Outcomes Total Score (Min = 24, Max = 120) reflects the caregiver's capacity to support their child's needs, with higher scores indicating greater capacity.
Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)
时间窗: Week 28
The Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP) is a structured, norm-referenced, observational measure of child communication. The assessment is scored for 20 items across 7 domains (i.e., Emotion and Eye Gaze, Communication, Gestures, Sounds, Words, Understanding, Object Use). The weighted raw scores for each of the 7 domains are grouped into 3 clusters (social, speech, and symbolic) and combined into a total raw score (min = 0; max = 113). Higher scores indicate better skills.
次要结局
- Framework for Reporting Adaptations and Modifications (FRAME)(Week 1 to Week 28)
- Session Attendance(Week 1 to Week 28)
- Intervention Fidelity Checklist(Week 1 to Week 28)
研究者
Megan Roberts
Principal Investigator
Northwestern University