Assessing the Effectiveness of Reciprocal Imitation Teaching in Part C Early Intervention Settings (Sprout Study)

NCT ID: NCT05425277

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2024-01-05

Brief Summary

Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to improve services and outcomes for children with early signs of ASD by testing the effectiveness of a brief, inexpensive training on EI providers' ability to deliver an evidence-based, caregiver-mediated intervention that can improve providers' comfort and effectiveness in working with families of children with social communication concerns, as well as improving child and family outcomes.

Detailed Description

Despite strong consensus that early, specialized intervention for children with Autism Spectrum Disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The long-term goal of this study is to improve services and outcomes for children with early signs of ASD by testing the effectiveness of training EI providers to deliver an evidence-based, inexpensive, caregiver-mediated intervention that can improve child and family outcomes as well as mitigate the substantial economic costs associated with ASD. This research will take place within an existing community-based infrastructure: the Part C Early Intervention (EI) service delivery system. Part C is publicly funded, available throughout the country, and serves children under age 3 who have developmental delays or disabilities, and their families. Currently, the effectiveness of EI services is limited by high practice variation and infrequent use of evidence-based interventions. The study objective is to improve services and outcomes for children with early signs of ASD and their families. Toward that end, the investigators are conducting a randomized controlled trial (RCT) examining the effectiveness of training EI providers to deliver Reciprocal Imitation Training (RIT), as compared to an active control condition. RIT is a naturalistic developmental behavioral intervention (NDBI) that is ideally suited for EI settings because it is low intensity, play-based, easy to learn and implement, and can be taught to families for their independent use, thus increasing intervention dosage. The investigators will conduct this study within the context of an effectiveness-implementation hybrid type 1 design to gather evidence that will be essential for implementing RIT in other communities if it is found to improve child and caregiver outcomes.

EI providers will be randomly assigned to either the RIT training (n=30) or an active control condition (n=30). Providers in both conditions will complete surveys about their caseloads and intervention practices at 5 time points, once before their training workshops and four times after the workshop (1, 3, 6, and 12 months post-training). Providers assigned to the RIT training condition will receive an 8-hour virtual workshop on the rationale for, and implementation of, RIT with families, with an emphasis on caregiver coaching. Providers assigned to the active control condition ('Daily Routines') will receive a 3-hour virtual workshop on methods for helping caregivers increase their children's participation and social engagement during everyday home routines. Providers in this condition will be able to receive RIT training at the end of the study.

Providers in both conditions will also invite 2 families from their caseload to participate in this study. Caregiver recruitment and data collection will begin immediately after the training workshops are conducted with providers. Enrolled families must speak and read English or Spanish and have a child between 18 and 30 months for whom ASD is either suspected or confirmed. Caregiver participation involves having one EI session videotaped, completing survey measures at 3 time points, and conducting a play-based assessment in their homes (with coaching) at the same 3 time points: baseline, 3 months later, and 6 months post-baseline. The play-based assessment will measure children's motor imitation, social communication, caregiver fidelity to RIT, and caregiver use of child-centered interaction strategies. At the same 3 timepoints, caregivers will complete measures about their parenting stress and parenting self-efficacy, their child's social communication and language, and any additional services the child is receiving. The child's adaptive behavior will be measured via caregiver-interview at baseline and 6-months. Caregivers will also report on the 'top concerns' they have about their child at baseline, and will rate the severity of these concerns monthly thereafter. Family-level "RIT dosage" will also be measured via a weekly Dosage Log sent to caregivers via text message. Caregiver-reported satisfaction with treatment and the study, as well as caregiver-reported child ASD symptomatology will be collected at their final visit (6-months after enrollment).

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RIT Training Group

Providers in the RIT group (n=30) will receive an 8-hour virtual workshop (2 half-days) on RIT implementation and caregiver coaching. Each provider will invite 2 families in their caseload to participate in the study. Providers will coach families in the use of RIT. One intervention session for each enrolled family will be videotaped and scored for RIT fidelity.

Group Type: EXPERIMENTAL

Reciprocal Intervention Teaching (RIT)

Intervention Type: BEHAVIORAL

RIT is a relatively straightforward, brief NDBI. It employs four simple strategies to target motor imitation and initiating joint attention during play: (1) contingent imitation of the child's verbal and nonverbal behavior, (2) linguistic mapping, (3) direct elicitation of object and gesture imitation following the child's interest, and (4) contingent reinforcement. It has been used at low intensities (e.g., 1-3 hours per week) over short periods of time (e.g., 10-12 weeks) to produce robust changes in pivotal social-communicative skills. RIT is easy to learn and can be implemented with fidelity by undergraduate-level therapists with limited backgrounds in ASD, as well as by caregivers and siblings.

Daily Routines

Providers in the Routines Control group (n=30) will receive a 3-hour virtual workshop focused on helping providers coach caregivers on how to increase children's participation and social engagement during everyday home routines (i.e., snack time, bedtime, bath time, and family playtime). Each provider will invite 2 families in their caseload to participate in the study. One intervention session for each enrolled family will be videotaped and scored for RIT fidelity to ensure contamination has not occurred and the control condition providers are not utilizing RIT strategies.

Group Type: ACTIVE_COMPARATOR

Daily Routines

Intervention Type: BEHAVIORAL

The Routines webinar was adapted from a web-based tutorial developed by PI Stone and colleagues (Ibanez et al., 2018). The webinar covers topics such as why everyday routines are important, especially for children with ASD, specific steps for increasing children's participation in routines, and how to use strategies such as visual supports to clarify expectations, and provides numerous video examples of caregivers using different strategies. Providers are also given access to a video library of caregivers using the Daily Routines strategies with their children, as well as a workbook to use with families during treatment.

Interventions

Reciprocal Intervention Teaching (RIT)

RIT is a relatively straightforward, brief NDBI. It employs four simple strategies to target motor imitation and initiating joint attention during play: (1) contingent imitation of the child's verbal and nonverbal behavior, (2) linguistic mapping, (3) direct elicitation of object and gesture imitation following the child's interest, and (4) contingent reinforcement. It has been used at low intensities (e.g., 1-3 hours per week) over short periods of time (e.g., 10-12 weeks) to produce robust changes in pivotal social-communicative skills. RIT is easy to learn and can be implemented with fidelity by undergraduate-level therapists with limited backgrounds in ASD, as well as by caregivers and siblings.

Intervention Type: BEHAVIORAL

Daily Routines

The Routines webinar was adapted from a web-based tutorial developed by PI Stone and colleagues (Ibanez et al., 2018). The webinar covers topics such as why everyday routines are important, especially for children with ASD, specific steps for increasing children's participation in routines, and how to use strategies such as visual supports to clarify expectations, and provides numerous video examples of caregivers using different strategies. Providers are also given access to a video library of caregivers using the Daily Routines strategies with their children, as well as a workbook to use with families during treatment.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

EI Providers:

• Speak and read English
• Work at a participating Part C practice or agency
• Have an active caseload that includes at least two children with ASD or suspected ASD
• Are willing to invite families to participate in this study

Caregivers and Toddlers (recruited from EI provider caseloads):

• Caregivers speak and read English or Spanish
• Caregivers are at least 18 years of age
• Caregivers are willing and able to participate in intervention sessions and research tele-visits that are video-recorded by research staff
• Child receives services from one of the participating agencies and attends regular sessions with the enrolled provider
• Child is between 18 and 30 months of age at study entry
• Child has a diagnosis of ASD or displays social communication impairments consistent with ASD

Exclusion Criteria

• Child has no severe visual, auditory, or physical impairments and no serious medical, genetic, or neurological conditions that would impede their ability to engage in RIT.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Wendy Stone

Professor, College of Arts & Sciences: Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wendy L Stone, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

W81XWH1910293

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00007803

Identifier Type: -

Identifier Source: org_study_id