|Title:||Examining the Efficacy of Project ImPACT for Toddlers|
|Principal Investigator:||Rieth, Sarah||Awardee:||San Diego State University|
|Program:||Early Intervention and Early Learning [Program Details]|
|Award Period:||4 years (07/01/2019-06/30/2023)||Award Amount:||$3,294,557|
Co-Principal Investigator: Stahmer, Aubyn
Purpose: The goal of this project is to examine the efficacy of Project ImPACT for Toddlers (PIT), a naturalistic intervention that focuses on building parents' capacity to support the social communication development of their children with or at risk for autism spectrum disorder (ASD) in community-based early intervention settings. Focusing on toddlers is important because ASD diagnoses are occurring earlier and there is evidence that intervening at the first signs of ASD risk, even before diagnosis, may help prevent the onset of symptoms for some children. Because services provided to toddlers at risk for ASD and their families vary based on geographic location, family demographics, and provider training, there is a need to test the efficacy of using sustainable methods of delivering high-quality services through existing early intervention systems. PIT, a community-based model of intervention, was designed to address this need. PIT was pilot tested in a previous IES project and demonstrated promise for improving children's communication and social skills and positive parenting behaviors within parent-child interactions compared to usual care early intervention. In the current study, the efficacy of PIT will be examined to determine whether it improves the fidelity of provider coaching of parents, fidelity of parent implementation of intervention techniques, and communication and social skills for children with or at risk for ASD. The potential moderating roles of family and child characteristics will also be examined.
Project Activities: The research team will evaluate PIT using a randomized wait-list controlled trial. Early intervention providers will be randomly assigned to receive training in PIT either 4 or 8 months after providing business-as-usual care. Once they receive training, they will provide the intervention to new families added to their caseloads. Families who received PIT after the providers' training will be compared to families who received usual care before the providers were trained to determine whether children from families who received the training demonstrate more significant improvements in communication and social skills. Researchers will examine whether child and family characteristics moderate the intervention's effect on parent and child outcomes as well as the cost-effectiveness of the intervention.
Products: This project will provide evidence of the efficacy and cost-effectiveness of PIT for toddlers with or at risk for ASD. The project will also result in a final dataset to be shared, peer-reviewed publications and presentations, and additional dissemination products that reach education stakeholders such as practitioners and policymakers.
Setting: This research will take place in family homes or community clinics where early intervention programs, funded by Part C of the Individuals with Disabilities Education Act, take place in California.
Sample: The participants for this study will include 60 early intervention providers and 230 families already receiving Part C services, including toddlers with or at risk for ASD (ages 12 to 30 months at the time of study enrollment) and their parents/caregivers.
Intervention: PIT is a naturalistic intervention that focuses on equipping parents to support the social and communication development of children 12-36 months of age with or at risk of ASD. Implemented through a parent-coaching framework within Part C systems, the evidence-based practices blend developmental science and applied behavior analysis. Early interventionists are trained with interactive, online, didactic instruction and in-person meetings with opportunities to practice, followed by support with a coach until they reach fidelity. The early interventionists then provide 12 weeks of training to parents in developmental and behavioral techniques to use with their child during daily activities. The curriculum includes provider and parent manuals, provider strategy guides, activity planners, and assessment materials to guide the development of child goals.
Research Design and Methods: The research team will use a randomized wait-list controlled trial to examine the efficacy of PIT. Upon enrollment, providers will be randomly assigned to either a 4-month or 8-month waiting period before receiving training in the intervention. During the waiting period, providers will deliver usual Part C early intervention services to two to four families for 4 months. Providers will then receive training and after training will deliver the intervention to two to four new families in their caseload. Outcomes assessed after 4 months of receiving early intervention services will be compared for children and their families who receive services before (control) versus after (intervention) the providers are trained. There will be two cohorts of participants. In the first year of the project, providers and families will be enrolled and pre-intervention data will be collected. In Year 2, the providers will receive training, with timing based on condition, followed by implementation of PIT. While the intervention is being implemented with the first cohort during Year 2, the second cohort will be enrolled and randomized, followed by data collection during usual services. In Year 3, the second cohort of providers will receive training and implement PIT with new families, continuing into Year 4. In Year 4, the final intervention phase will end, post-intervention data will be collected on this cohort, and the team will analyze and disseminate the results. Data will be analyzed to examine whether children exhibit greater improvements in communication and social skills as a result of participating in the intervention group as well as determine whether child and family characteristics—including socioeconomic status, maternal education, marital status, child functional communication, and child age—moderate the intervention impacts. The research team will also explore the cost-effectiveness of the intervention.
Control Condition: The control condition will include early intervention services as usual, delivered by Part C providers before they receive any training in PIT.
Key Measures: Child outcome measures include Communication-Symbolic Behavior Scales to measure social communication, the Preschool Language Scales, and the Vineland Adaptive Behavior Scales. Parent outcomes include the Parenting Interactions with Children: Checklist of Observations Linked to Outcomes to measure developmentally supportive parenting behaviors and an intervention fidelity checklist scored from video observations. Provider outcomes in both groups include fidelity of parent coaching with PIT strategies assessed through video-recorded sessions, surveys about their use of intervention practices, an intervention satisfaction questionnaire, and a final implementation survey examining their use and possible barriers to implementation of the intervention. Additional child measures to characterize the sample and examine as moderators include questionnaires to determine child and family demographics, child developmental history, and family use of other interventions; Bayley Scales of Infant Development; and the Autism Diagnostic Observation Schedule—Toddler to determine severity of risk.
Data Analytic Strategy: Multilevel modeling will be used to determine the intervention's efficacy. Models will take into account the nesting of time within families and families within early intervention providers. Moderators will be explored through interaction terms in the model. The team will examine the cost-effectiveness of the intervention by estimating the incremental net benefit of PIT compared to usual practice using net benefit regression.
Related Projects: Adapting an Evidence-Based Program for Infants and Toddlers at High Risk for Autism (R324A140004)