NCT06080087

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

September 30, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

July 9, 2023

Last Update Submit

October 5, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Measure of NDBI Strategy Implementation: Caregiver Change (MONSI-CC)

    Change from baseline at 8 weeks

  • Autism-specific parenting self-efficacy

    Change from baseline at 8 weeks

  • Social validity

    Change from baseline at 8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group will receive access to the I-TEAM

Behavioral: I-TEAM

Waitlist control

NO INTERVENTION

Waitlist control group will not receive access to the I-TEAM until the Intervention group has completed the 8-week intervention.

Interventions

I-TEAMBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not able to complete I-TEAM as instructed
  • 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
  • Not currently receiving early intervention services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98115, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be blinded into which condition they were assigned into
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 9, 2023

First Posted

October 12, 2023

Study Start

September 30, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2026

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations