AutismNCT06314438
Culturally-Responsive Curriculum for Caregivers With Children at Autism Likelihood
A study testing Family Care Project in people with Autism and Development Delay, run by University of Washington at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine how helpful and relevant the Family Care Project workbook is for families from culturally and linguistically diverse backgrounds who have a young child at autism likelihood. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Development Delay
- What is being tested?
- Family Care Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2023to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has a child who screens at likelihood on the Ages and Stages Questionnaire
- Speaks one of the following languages: Arabic, Mai Mai, Swahili, French, Tigrinya, Dari
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Co-Developing and Piloting Culturally-Responsive Informational Materials About Autism for Families of Young Children: Employing a Train-the-Trainer Implementation Model Within a Nonprofit Setting
The goal of this clinical trial is to examine how helpful and relevant the Family Care Project workbook is for families from culturally and linguistically diverse backgrounds who have a young child at autism likelihood. The main questions this trial aims to answer are:
- Is the Family Care Project workbook useful for families?
- Is the Family Care Project workbook easy to use?
- Can the Family Care Project be implemented by non-profit workers who do not have health backgrounds?
Participants will complete surveys that elicit their feedback on their use of the workbook.
Read the detailed description
Access to early, evidence-based autism-specific treatment can profoundly improve long-term outcomes for children with Autism Spectrum Disorder (ASD). However, current estimates reveal an eight-month to three-year gap between caregiver first concerns about their child's ASD-related behaviors and receipt of ASD-specific services. This prolonged time-period between caregiver first concerns and receipt of ASD-specific services is characterized by elevated parenting stress, increased child behavioral challenges, and reduced quality of life, even compared to families of children with non-ASD developmental concerns. Unfortunately, culturally and linguistically diverse (CALD) communities experience lengthier time-periods between first concerns and receipt of services, report increased difficulty accessing timely diagnostic and treatment services, and ultimately experience worse health outcomes compared to White communities. The investigators will partner with Mother Africa, a local non-profit organization, to 1) co-design culturally-responsive caregiver-focused educational materials to support CALD families with young children who have social communication delays or ASD and 2) develop a novel route for dissemination of information and materials within non-profit organizations, which are often the preferred entry-point for accessing healthcare information and services for underserved populations, rather than traditional medical facilities. The educational materials will support caregiver and child well-being by increasing caregiver knowledge and use of ASD specific parenting strategies as well as increasing caregiver awareness and use of local ASD resources. This planned research has the potential to effect programmatic changes in the services and settings available to support CALD communities during the early years of a child's ASD condition and thereby improve child and caregiver outcomes.
- Conditions
- Autism, Development Delay
- Being tested
- Family Care Project
- Medical subject headings
- Autistic Disorder, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Care ProjectBehavioural
Caregivers will be administered the Family Care Project workbook.
| Study group | Role | What they receive |
|---|---|---|
| Family Care Project workbook | Experimental | Caregivers will be administered the Family Care Project workbook. Receives: Behavioral: Family Care Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
Staff Training Feedback Survey of Implementation Properties (Self-report)
Through a study-specific survey, staff will answer questions about the acceptability, feasibility, and appropriateness of the training. Staff will also have the opportunity to offer suggestions for improvements to the training curriculum. This questionnaire is administered online.
Measured: 1 week after staff complete training in Family Care Project, which is 1 week before the pilot commences
Staff Competence in Assisting Families With Children At-autism Likelihood Survey (Self-report)
Through a study-specific survey, staff will self-report their competence in identifying caregiver concerns, helping caregivers access services, providing new parenting strategies to caregivers, and helping caregivers set up a self-care plan. They will complete these questions via a survey and rate a score on a Likert scale of agreement with statements that reflect these topics. Higher scores indicate greater competence in assisting families with children at-autism likelihood.
Scale title: Family Support Sister Self-Competence in Family Care Project Topics Minimum score: 1 Maximum score: 5
Measured: 1 week after implementation of Family Care Project with pilot families
The Maternal Self-Efficacy Scale Questionnaire
This questionnaire is a validated measure of caregivers' beliefs about their performance (i.e., self-efficacy) in caregiving tasks. Caregivers will fill out the survey online. They will complete these questions via a survey and rate a score on a Likert scale of agreement. Higher scores indicate greater maternal self-efficacy.
Scale title: Maternal Self-Efficacy Scale Minimum score: 1 Maximum score: 4
Measured: During the last session of the Family Care Project, which is approximately 4-6 weeks after the start of the pilot depending on family preferences
Caregiver Knowledge and Use of Behaviors That Support Children at Autism-likelihood Survey
Through a study-specific survey, caregivers will answer questions about their knowledge of child development, navigating appropriate child services, setting up a visual support, and creating a self-care plan. They will also answer questions about whether they have used a visual support or implemented a self-care routine. This survey is study-specific and created based on the curriculum topics. It will be filled out via online survey and caregivers will rate a score on a Likert scale of agreement with statements that reflect these topics. Higher scores indicate greater knowledge and use of behaviors to support children at autism-likelihood.
Scale title: Caregiver Knowledge and Use Minimum score: 1 Maximum score: 5
Measured: During the last session of the Family Care Project, which is approximately 4-6 weeks after the start of the pilot depending on family preferences
Current Services Utilized by Families to Support Children at Autism-likelihood Survey
Through a study-specific survey, caregivers will answer questions about their child's developmental diagnostic evaluations or current developmental services in the community. They will complete the survey online.
Measured: During the last session of the Family Care Project, which is approximately 4-6 weeks after the start of the pilot depending on family preferences
Family Care Project Feedback Survey of Implementation Properties
Through a study-specific survey, mother africa staff and caregivers will answer questions about the acceptability, feasibility, and appropriateness of the Family Care Project and suggestions for revisions. They will fill out questions on an online survey.
It will be filled out via online survey and all participants will rate a score on a Likert scale of agreement with statements about the acceptability, feasibility, and/or appropriateness of the Family Care Project. Higher scores indicate greater acceptability, feasibility, and/or appropriateness of the Family Care Project.
Scale title: Family Care Project Feedback Minimum score: 1 Maximum score: 5
Measured: During the last session of the Family Care Project, which is approximately 4-6 weeks after the start of the pilot depending on family preferences
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start15 Dec 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Hannah Benavidez, University of Washington
- Investigators
- Wendy L Stone, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314438
- Sponsor's protocol ID
- STUDY00017189
- Other IDs
- UL1TR002319
- Status last verified
- Apr 2025
- First submitted
- 21 Dec 2023
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-Developing and Piloting Culturally-Responsive Informational Materials About Autism for Families of Young Children: Employing a Train-the-Trainer Implementation Model Within a Nonprofit Setting
- ClinicalTrials.gov ID
- NCT06314438
- Acronym / sponsor ID
- STUDY00017189
- Conditions
- Autism, Development Delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Posted 4 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to examine how helpful and relevant the Family Care Project workbook is for families from culturally and linguistically diverse backgrounds who have a young child at autism likelihood. The main questions this trial aims to answer are:
- Is the Family Care Project workbook useful for families?
- Is the Family Care Project workbook easy to use?
- Can the Family Care Project be implemented by non-profit workers who do not have health backgrounds?
Participants will complete surveys that elicit their feedback on their use of the workbook.
Detailed description
Access to early, evidence-based autism-specific treatment can profoundly improve long-term outcomes for children with Autism Spectrum Disorder (ASD). However, current estimates reveal an eight-month to three-year gap between caregiver first concerns about their child's ASD-related behaviors and receipt of ASD-specific services. This prolonged time-period between caregiver first concerns and receipt of ASD-specific services is characterized by elevated parenting stress, increased child behavioral challenges, and reduced quality of life, even compared to families of children with non-ASD developmental concerns. Unfortunately, culturally and linguistically diverse (CALD) communities experience lengthier time-periods between first concerns and receipt of services, report increased difficulty accessing timely diagnostic and treatment services, and ultimately experience worse health outcomes compared to White communities. The investigators will partner with Mother Africa, a local non-profit organization, to 1) co-design culturally-responsive caregiver-focused educational materials to support CALD families with young children who have social communication delays or ASD and 2) develop a novel route for dissemination of information and materials within non-profit organizations, which are often the preferred entry-point for accessing healthcare information and services for underserved populations, rather than traditional medical facilities. The educational materials will support caregiver and child well-being by increasing caregiver knowledge and use of ASD specific parenting strategies as well as increasing caregiver awareness and use of local ASD resources. This planned research has the potential to effect programmatic changes in the services and settings available to support CALD communities during the early years of a child's ASD condition and thereby improve child and caregiver outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family Care Project workbook | Experimental | Behavioral: Family Care ProjectCaregivers will be administered the Family Care Project workbook. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has a child who screens at likelihood on the Ages and Stages Questionnaire
- Speaks one of the following languages: Arabic, Mai Mai, Swahili, French, Tigrinya, Dari
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Family Care ProjectCaregivers will be administered the Family Care Project workbook. | Behavioural | Family Care Project workbook |
Primary outcome
Staff Training Feedback Survey of Implementation Properties (Self-report)
Time frame: 1 week after staff complete training in Family Care Project, which is 1 week before the pilot commences
Through a study-specific survey, staff will answer questions about the acceptability, feasibility, and appropriateness of the training. Staff will also have the opportunity to offer suggestions for improvements to the training curriculum. This questionnaire is administered online.
Staff Competence in Assisting Families With Children At-autism Likelihood Survey (Self-report)
Time frame: 1 week after implementation of Family Care Project with pilot families
Through a study-specific survey, staff will self-report their competence in identifying caregiver concerns, helping caregivers access services, providing new parenting strategies to caregivers, and helping caregivers set up a self-care plan. They will complete these questions via a survey and rate a score on a Likert scale of agreement with statements that reflect these topics. Higher scores indicate greater competence in assisting families with children at-autism likelihood. Scale title: Family Support Sister Self-Competence in Family Care Project Topics Minimum score: 1 Maximum score: 5
The Maternal Self-Efficacy Scale Questionnaire
Time frame: During the last session of the Family Care Project, which is approximately 4-6 weeks after the start of the pilot depending on family preferences
This questionnaire is a validated measure of caregivers' beliefs about their performance (i.e., self-efficacy) in caregiving tasks. Caregivers will fill out the survey online. They will complete these questions via a survey and rate a score on a Likert scale of agreement. Higher scores indicate greater maternal self-efficacy. Scale title: Maternal Self-Efficacy Scale Minimum score: 1 Maximum score: 4
Caregiver Knowledge and Use of Behaviors That Support Children at Autism-likelihood Survey
Time frame: During the last session of the Family Care Project, which is approximately 4-6 weeks after the start of the pilot depending on family preferences
Through a study-specific survey, caregivers will answer questions about their knowledge of child development, navigating appropriate child services, setting up a visual support, and creating a self-care plan. They will also answer questions about whether they have used a visual support or implemented a self-care routine. This survey is study-specific and created based on the curriculum topics. It will be filled out via online survey and caregivers will rate a score on a Likert scale of agreement with statements that reflect these topics. Higher scores indicate greater knowledge and use of behaviors to support children at autism-likelihood. Scale title: Caregiver Knowledge and Use Minimum score: 1 Maximum score: 5
Current Services Utilized by Families to Support Children at Autism-likelihood Survey
Time frame: During the last session of the Family Care Project, which is approximately 4-6 weeks after the start of the pilot depending on family preferences
Through a study-specific survey, caregivers will answer questions about their child's developmental diagnostic evaluations or current developmental services in the community. They will complete the survey online.
Family Care Project Feedback Survey of Implementation Properties
Time frame: During the last session of the Family Care Project, which is approximately 4-6 weeks after the start of the pilot depending on family preferences
Through a study-specific survey, mother africa staff and caregivers will answer questions about the acceptability, feasibility, and appropriateness of the Family Care Project and suggestions for revisions. They will fill out questions on an online survey. It will be filled out via online survey and all participants will rate a score on a Likert scale of agreement with statements about the acceptability, feasibility, and/or appropriateness of the Family Care Project. Higher scores indicate greater acceptability, feasibility, and/or appropriateness of the Family Care Project. Scale title: Family Care Project Feedback Minimum score: 1 Maximum score: 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wendy L Stone, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Care Project in people with Autism and Development Delay, run by University of Washington 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 4 May 2025. 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?
Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Staff Training Feedback Survey of Implementation Properties (Self-report) (time frame: 1 week after staff complete training in Family Care Project, which is 1 week before the pilot commences). The study lists 6 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 4 May 2025.