AutismNCT06080087
Implementation Toolkit to Enhance EBP Among Marginalized Families
A study testing I-TEAM in people with Autism and Early Intervention, run by Seattle Children's Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism, Early Intervention
- What is being tested?
- I-TEAM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2023to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently working with minoritized families of young children within Part-C
- Willing to complete I-TEAM as instructed
- Over the age of 18
- 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
Who cannot join
- Not able to complete I-TEAM as instructed
- Not currently receiving early intervention services
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Research Institute
Seattle, Washington, 98115
About this study
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.
- Conditions
- Autism, Early Intervention
- Being tested
- I-TEAM
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-TEAMBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group will receive access to the I-TEAM Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coaching Fidelity Scale (CFS)
CFS is an observational measure to assess coaching fidelity during an interaction between a coach and a learner
Measured: 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
Measured: Change from baseline at 8 weeks
Social Validity
We will measure acceptability and feasibility of I-TEAM
Measured: Change from baseline at 8 weeks
Secondary outcomes (3)
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
Measured: Change from baseline at 8 weeks
Autism-specific parenting self-efficacy
We will use this self-reported tool to assess self-efficacy of parents of young autistic children
Measured: Change from baseline at 8 weeks
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
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start30 Sep 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, James Lee, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080087
- Sponsor's protocol ID
- STUDY00004246
- Status last verified
- Oct 2023
- First submitted
- 9 Jul 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Toolkit to Enhance EBP Among Marginalized Families
- ClinicalTrials.gov ID
- NCT06080087
- Acronym / sponsor ID
- STUDY00004246
- Conditions
- Autism, Early Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: I-TEAMIntervention group will receive access to the 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Currently working with minoritized families of young children within Part-C
- Willing to complete I-TEAM as instructed
- Over the age of 18
- 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
Key exclusion criteria (2 listed)
- Not able to complete I-TEAM as instructed
- Not currently receiving early intervention services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-TEAMI-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 | Behavioural | Intervention |
Primary outcome
Coaching Fidelity Scale (CFS)
Time frame: 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)
Time frame: 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
Time frame: Change from baseline at 8 weeks
We will measure acceptability and feasibility of I-TEAM
3 secondary outcomes
Measure of NDBI Strategy Implementation: Caregiver Change (MONSI-CC)
Time frame: Change from baseline at 8 weeks
Autism-specific parenting self-efficacy
Time frame: Change from baseline at 8 weeks
Social validity
Time frame: Change from baseline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-TEAM in people with Autism and Early Intervention, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coaching Fidelity Scale (CFS) (time frame: Change from baseline at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023; AzTrials last refreshed its copy on 1 Nov 2026.