ClinicalTrials.gg
Status unknownNCT06080087Updated Oct 12, 2023

Implementation Toolkit to Enhance EBP Among Marginalized Families

An interventional study of I-TEAM in Autism and Early Intervention, sponsored by Seattle Children's Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-12.

Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Autism
  • Early Intervention

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In context

Autistic Disorder

1,360 studies on the registry are indexed under Autistic Disorder; 332 are open to participants now.

This study's enrollment of 40 is below the median of 46 across 1,058 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Seattle Children's Hospital is the lead sponsor of 214 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Intervention

    Intervention group will receive access to the I-TEAM

    Behavioral: I-TEAM

  • 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.

Interventions

  • BehavioralI-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

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What researchers measure

Primary outcomes

  1. Coaching Fidelity Scale (CFS)

    CFS is an observational measure to assess coaching fidelity during an interaction between a coach and a learner

    Time frame: Change from baseline at 8 weeks

  2. 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

    Time frame: Change from baseline at 8 weeks

  3. Social Validity

    We will measure acceptability and feasibility of I-TEAM

    Time frame: Change from baseline at 8 weeks

Secondary outcomes

  1. 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

    Time frame: Change from baseline at 8 weeks

  2. Autism-specific parenting self-efficacy

    We will use this self-reported tool to assess self-efficacy of parents of young autistic children

    Time frame: Change from baseline at 8 weeks

  3. 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

    Time frame: Change from baseline at 8 weeks

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Study locations

1 site
  • Seattle Children's Research Institute
    Seattle, Washington 98115, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06080087
Responsible party
James Lee (Assistant Professor, Seattle Children's Hospital) — Principal investigator
First posted
Oct 12, 2023
Start date
Sep 30, 2023
Primary completion
Feb 1, 2024 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Oct 12, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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