Implementation Toolkit to Enhance EBP Among Marginalized Families

Autism Clinical Trial

Official title:

Implementation Toolkit to Enhance EBP Among Marginalized Families

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06080087
• Other study ID #: STUDY00004246
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: October 2023
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Early Intervention

Intervention

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

Locations

Country	Name	City	State
United States	Seattle Children's Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Social Validity	We will measure acceptability and feasibility of I-TEAM	Change from baseline at 8 weeks
Secondary	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
Secondary	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
Secondary	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