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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06080087
Other study ID # STUDY00004246
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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