Implementation Toolkit to Enhance EBP Among Marginalized Families

Sponsor

Seattle Children's Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06080087

Collaborator

University of Washington (Other)

Enrollment

Location

Arms

28.1

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Early Intervention	Behavioral: I-TEAM	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Participants will not be blinded into which condition they were assigned into

Primary Purpose:

Treatment

Official Title:

Implementation Toolkit to Enhance EBP Among Marginalized Families

Actual Study Start Date :

Sep 30, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seattle Children's Research Institute	Seattle	Washington	United States	98115

Sponsors and Collaborators

Seattle Children's Hospital
University of Washington

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

James Lee, Assistant Professor, Seattle Children's Hospital

ClinicalTrials.gov Identifier:

NCT06080087

Other Study ID Numbers:

STUDY00004246

First Posted:

Oct 12, 2023

Last Update Posted:

Oct 12, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 12, 2023