Effects of Technology-Supported Social Communication Baby Navigator Intervention to Improve Outcomes of Toddlers With Communication Delays: Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Parent contingent responsiveness change over time
研究概览
简要总结
A confluence of empirical research on poverty, environmental risk factors, and brain development shows that early experiences are uniquely powerful in the first years of life, providing further impetus for early detection and intervention. Measures of early-developing social communication skills offer a viable solution for earlier detection of children with language delays and subsequent educational challenges. The investigators propose testing a new technology-supported platform with three parent-mediated intervention components for babies with early communication delays using mobile technology: 1) the Social Communication Growth Charts, a self-guided app to explore video clips illustrating early milestones and to chart their child's development; 2) Baby Navigator Webinar, webinars open to the public designed as a companion to the Growth Charts; and 3) Mobile Coaching, individual weekly telehealth sessions to coach parents in their everyday activities. The investigators propose using a multiphase optimization strategy (MOST) as a framework for development, optimization, and evaluation of our dynamic web intervention platform. The Investigators will recruit 80 children with communication delays at 12-18 months of age. Families will be invited to the Social Communication Growth Charts bundled with the Baby Navigator Webinar. At 18-21 months, slow responders will be randomized to continue the bundle with or without Mobile Coaching, and responders will continue the bundle. This study will enhance the sustainability, scalability, and lead to transformative changes to efficiently and effectively improve healthcare delivery via the use of innovative technology, an implementation science methodology, and user-friendly tools and web platform.
详细描述
BACKGROUND AND AIMS:
About one in three children in the U.S. enter kindergarten unprepared to learn and lacking sufficient communication skills. Despite the federal mandate for early intervention (EI), less than 25% of children who will require special education at school age are receiving EI services under three years of age. Lower income, African American, and rural families may receive a diagnosis 1.5 years later. Twenty-five years after Hart and Risley described the 30-million-word gap between children from higher and lower socioeconomic backgrounds, "catching up" earlier is emphasized more than ever, and intervention beginning during infancy or preschool has a greater impact on outcomes for children than providing services at school age. A confluence of empirical research on poverty, environmental risk factors, and brain development shows that early experiences are uniquely powerful in the first years of life with lasting effects on developmental trajectories and significant impact on lifelong well-being, providing further impetus for early detection and intervention.
There is a pressing need to leverage resources by coordinating care provided by the many different agencies serving young children and test new methods to support families as soon as their children begin to show small lags in communication development. The investigators' research has identified robust predictors of later language development that can be identified at 9-18 months of age. Because delays in communication are apparent long before language delays are evident, measures of early-developing social communication skills offer a viable solution for earlier detection of children with language delays and subsequent educational challenges.
The investigators propose studying a new technology-supported intervention for babies with early communication delays-Social Communication "Baby Navigator" Intervention-that builds on the findings of our efficacy trial of the Early Social Interaction (ESI) Model to coach families of toddlers with autism to embed evidence-based intervention strategies in their everyday activities. The content of Baby Navigator is based on responsive parenting research that has a strong evidence-base for children from very low resource settings worldwide and is recommended to improve child health and development by the World Health Organization (WHO). Responsive parenting defined by WHO entails observing the child's cues, such as movements and sounds, interpreting these signals accurately, and acting swiftly, consistently and efficiently to meet the child's needs. Baby Navigator is a web platform with three parent-mediated intervention components using mobile technology: 1) the Social Communication Growth Charts, a self-guided application (app) to explore hundreds of video clips illustrating early milestones with narration on responsive parenting and to chart their child's development; 2) Baby Navigator Class, group weekly online meetings designed as a companion to the Growth Charts to engage parents while learning the milestones and how to support their child's development, and connect with other families; and 3) Mobile Coaching, individual weekly telehealth sessions to coach parents and provide reflective feedback in their everyday activities, adapted from the ESI model.
The investigators will address the following research aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinician administering the Preschool Language Scales will be blind to group assignment.
入排标准
- 年龄范围
- 12 Months 至 18 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for parent/child dyads:
- •parent completes the SoCo CheckUp (available at https://babynavigator.com) screening at 12-18 months of age and child has a positive screen for communication delay
- •parent completes the CSBS CQ and child falls below the 10th percentile at 12-18 months
- •parent records and submits/uploads a home observation video at 12-18 months
- •speaks English or Spanish at home
- •agrees to be in the intervention study
排除标准
- •child over 18 months of age at beginning of study
- •child shows 5 or more red flags for autism based on the home observation video scored with the SORF (Systematic Observation of Red Flags) of ASD
- •parent/child dyad does not speak English or Spanish
- •family lives outside of the United States
- •parent does not agree to be video recorded as part of the study
研究组 & 干预措施
Baby Navigator Bundle
Parent and child measures, including a home observation video, will be collected at baseline, after which study staff will use Motivational Interviewing techniques to engage families to access resources and support (Baby Navigator Bundle) when parents first learn their child has social communication/language delay. Families may use the Baby Navigator Bundle as little or as much as desired. The Baby Navigator Bundle includes: Social Communication Growth Charts and the Baby Navigator webinar series.
干预措施: Baby Navigator Bundle (Behavioral)
Baby Navigator Bundle + Individual-ESI
At 18-21months of age, slow responders (communication delay still below the 10th percentile) will be randomized to continue the Baby Navigator Bundle with or without Individual-ESI, and responders (communication above the 10th percentile) will continue with Baby Navigator Bundle. For Individual ESI, trained coaches or family navigators will coach families using the Early Social Interaction (ESI) model. ESI teaches parents how to support their child's social communication, language, play and behaviors in everyday routines, activities, and places. Family navigators will also engage the family in the How-to Guide for Families online course. The family navigator will use zoom or other telehealth platform to meet with parents 1 time per week for 30-60 minutes per session for 6 months.
干预措施: Baby Navigator Bundle + Individual-ESI (Behavioral)
Baby Navigator Bundle + Individual-ESI
At 18-21months of age, slow responders (communication delay still below the 10th percentile) will be randomized to continue the Baby Navigator Bundle with or without Individual-ESI, and responders (communication above the 10th percentile) will continue with Baby Navigator Bundle. For Individual ESI, trained coaches or family navigators will coach families using the Early Social Interaction (ESI) model. ESI teaches parents how to support their child's social communication, language, play and behaviors in everyday routines, activities, and places. Family navigators will also engage the family in the How-to Guide for Families online course. The family navigator will use zoom or other telehealth platform to meet with parents 1 time per week for 30-60 minutes per session for 6 months.
干预措施: Baby Navigator Bundle (Behavioral)
结局指标
主要结局
Parent contingent responsiveness change over time
时间窗: Baseline, and 6-12 months after start of intervention
Parent contingent responsiveness will be periodically assessed using the Measure of Active Engagement and Transactional Supports (MAETS), a rating of a video-recorded home observation of parent-child interaction during everyday activities. The MAETS includes 8 AE components: participation and a productive role; predictable activities; language that follows the child's focus of attention; child initiations; balance of communicative turns; messages to support child comprehension; verbal and nonverbal models; and appropriate expectations and demands. These components align with the Research Domain Criteria (RDoC) constructs. Parents use of evidenced-based intervention strategies to promote AE comprise the TS subscale. Both subscales form a MAETS composite. Each component is scored on a 4-point scale where 0 = Absent, 1 = Emerging, 2 = Practicing, and 3 = Mastery. Total scores range from 0 to 48 and higher scores indicate that the level of parent support is better.
Child social communication change over time
时间窗: Baseline, and 6-12 months after start of intervention
Change in social communication skills will be periodically measured with the Communication and Symbolic Behavior Scales (CSBS) Caregiver Questionnaire. The caregiver will complete the questionnaire by reporting on their child's social communication skills. The raw scores will be summed to form a social, speech, and symbolic composite. The social composite includes emotion and eye gaze and communication and gestures; and possible composite scores range from 0 to 48. The speech composite includes sounds and words, and possible composite scores range from 0 to 40. The symbolic composite includes understanding and object use, and possible scores for this composite range from 0 to 51. The total summed score for all 3 composites ranges from 0 to 139. Higher scores on the composites and total indicate better social communication skills.
次要结局
- Child behavior and vocabulary checklist(Baseline, and 6-12 months after start of intervention)
- Standardized assessment of language(Baseline, and 6-12 months after start of intervention)
研究者
Amy M. Wetherby
Distinguished Research Professor
Florida State University
