Implementation Toolkit to Enhance EBP Among Marginalized Families

Although the efficacy of early intervention (EI) for autistic children and their families has been established, many marginalized families with diverse cultural and linguistic backgrounds still report inequitable access to evidence-based practices (EBP). There are several strategies to increase EBP implementation that are especially relevant to marginalized families who report inequitable access to coaching from EI providers, such as increasing the capacity of EI providers to coach families in a culturally responsive way. However, EI providers are provided with limited professional development in both family coaching and cultural responsiveness, which results in perpetuation of EBP implementation failure. Thus, it is crucial to develop and validate an implementation toolkit that comprises strategies to enhance cultural responsiveness in the uptake of EBPs among EI providers. Therefore, the overall purpose of this research is to identify facilitators and barriers of EBP implementation among marginalized families in EI to aid the development an implementation toolkit with a focus on capacity building of EI providers to implement EBP with cultural responsiveness. This will involve conducting individual interviews with EI providers.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism; Early Intervention
• Intervention / Treatment: Behavioral: I-TEAM

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98115
      • Seattle Children's Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

There are two sets of inclusion criteria for both types of participants.

Inclusion Criteria for EI providers:

• Currently working with minoritized families of young children within Part-C
• Willing to complete I-TEAM as instructed
• Over the age of 18

Exclusion Criteria for EI providers:

• Not able to complete I-TEAM as instructed

Inclusion Criteria for families:

• Having a minoritized backgrounds (e.g., migrant/refugee background, primarily speaks another language other than English at home)
• Having a young child eligible for early intervention services

Exclusion Criteria for EI providers:

• Not currently receiving early intervention services

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Intervention group will receive access to the I-TEAM	Behavioral: I-TEAM; I-TEAM is a web-based implementation toolkit that supports to enhance cultural responsiveness of EI providers in their EBP delivery with minoritized families of young autistic children
No Intervention: Waitlist control; Waitlist control group will not receive access to the I-TEAM until the Intervention group has completed the 8-week intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coaching Fidelity Scale (CFS)	CFS is an observational measure to assess coaching fidelity during an interaction between a coach and a learner	Change from baseline at 8 weeks
Cultural Self-Efficacy Scale for Early Interventionists (CSES-EI)	CSES-EI is a 32-item, self-reported measure of cultural self-efficacy of early intervention providers	Change from baseline at 8 weeks
Social Validity	We will measure acceptability and feasibility of I-TEAM	Change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of NDBI Strategy Implementation: Caregiver Change (MONSI-CC)	MONSI-CC is an observational measure that detects changes in caregivers' use of NDBI strategies in early intervention	Change from baseline at 8 weeks
Autism-specific parenting self-efficacy	We will use this self-reported tool to assess self-efficacy of parents of young autistic children	Change from baseline at 8 weeks
Social validity	We will assess social validity, including satisfaction with their services, reports of cultural responsiveness of their providers, acceptability of early intervention among intervention recipients	Change from baseline at 8 weeks

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: July 9, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00004246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No