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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002319 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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:
Participants will complete surveys that elicit their feedback on their use of the workbook.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family Care Project workbook | Experimental | Caregivers will be administered the Family Care Project workbook. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family Care Project | Behavioral | Caregivers will be administered the Family Care Project workbook. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Wendy L Stone, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mother Africa | Kent | Washington | 98032 | United States |
No participants were excluded from participation in this study.
Our community organization recruit eligible families.
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| ID | Title | Description |
|---|---|---|
| FG000 | Family Care Project Workbook-Caregivers | Caregivers will be administered the Family Care Project workbook. |
| FG001 | Family Care Project Workbook-nonspecialist Providers | Non-specialist providers administered the Family Care Project workbook to caregivers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Family Care Project Workbook-caregivers | Caregivers will be administered the Family Care Project workbook. |
| BG001 | Family Care Project Workbook-nonspecialist Providers. | Nonspecialist providers will administer the Family Care Project workbook to caregivers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Demographic Survey |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | It was supposed to be non-specialist providers who completed the web-based tutorial (n=6); however, data was not collected properly because there was an issue with the online questionnaire, specifically the Likert scale was presented incorrectly (i.e., the neutral and slightly agree were accidentally combined into "NeutraCompletelyee") and some providers chose this anchor. Therefore, we cannot infer what the providers intended in their selection of this inaccurate anchor. | Posted | 1 week after staff complete training in Family Care Project, which is 1 week before the pilot commences |
|
We did not formally collect adverse event data during study.
Deaths and adverse events were not assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Family Care Project Workbook | Caregivers will be administered the Family Care Project workbook. Family Care Project: Caregivers will be administered the Family Care Project workbook. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | University of Washington | 206-221-3595 | stonew@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2025 | Mar 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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. | 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 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Demographic Survey | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Demographic Survey | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Demographic Survey | Count of Participants | Participants | No |
|
| 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 | Only includes non-specialist providers who delivered Family Care Project to caregivers. Caregivers did not complete this baseline measure | Mean | Standard Deviation | score on a scale |
|
| 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 | Only includes caregivers who completed the Family Care Project and the maternal self-efficacy survey. Does not include non-specialist providers in study. 12 caregivers did not complete the entire survey and data could not be reported for these caregivers | Mean | Standard Deviation | score on a scale |
|
| Caregiver Knowledge and Use of Behaviors that Support Children at autism-likelihood Survey | Caregivers answer questions about their knowledge of child development, navigating appropriate child services, setting up a visual support, and creating a self-care plan. 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 | Includes only caregivers who completed Family Care Project and completed the survey. Non-specialist providers did not complete this measure. 15 caregivers did not complete the survey in its entirety in order to be reported. | Mean | Standard Deviation | score on a scale |
|
| 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. | Includes only caregivers who completed the Family Care Project and survey. Non-specialist providers did not complete this survey. | Count of Participants | Participants | No |
|
Caregivers will be administered the Family Care Project workbook. |
| OG001 | Family Care Project Workbook-nonspecialist Providers | Nonspecialist providers will administer the Family Care Project workbook to caregivers. |
|
| Primary | 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 | All non-specialist providers who delivered Family Care Project to caregivers. | Posted | Mean | Standard Deviation | score on a scale | 1 week after implementation of Family Care Project with pilot families |
|
|
|
|
| Primary | 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 | Caregivers who completed the Family Care Project and the maternal self-efficacy survey. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Primary | 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 | Caregivers who completed Family Care Project and completed the survey. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
|
| Primary | 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. | Caregivers who completed the Family Care Project and survey. | Posted | Count of Participants | Participants | 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 |
|
|
|
| Primary | 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 | Caregivers and non-specialist providers who completed the surveys. All participated in Family Care Project (either received it or delivered it). | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Acceptability |
|
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| Feasibility |
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