Autism, Development Delay
Conditions
Brief 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. 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.
Interventions
BEHAVIORALFamily Care Project
Caregivers will be administered the Family Care Project workbook.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Staff Training Feedback Survey of Implementation Properties (Self-report) | 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) | 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 | 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 | 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 | 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 | 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 |
Countries
United States
Participant flow
Recruitment details
Our community organization recruit eligible families.
Pre-assignment details
No participants were excluded from participation in this study.
Participants by arm
| Arm | Count |
|---|---|
| Family Care Project Workbook-caregivers Caregivers will be administered the Family Care Project workbook. | 35 |
| Family Care Project Workbook-nonspecialist Providers. Nonspecialist providers will administer the Family Care Project workbook to caregivers | 6 |
| Total | 41 |
Baseline characteristics
| Characteristic | Family Care Project Workbook-caregivers | Family Care Project Workbook-nonspecialist Providers. | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 6 Participants | 41 Participants |
| Caregiver Knowledge and Use of Behaviors that Support Children at autism-likelihood Survey | 3.81 score on a scale STANDARD_DEVIATION 0.82 | — | 3.81 score on a scale STANDARD_DEVIATION 0.82 |
| Current Services Utilized by Families to Support Children at autism-likelihood Survey Caregivers who did not received a diagnostic or intervention referral before Family Care Project | 30 Participants | — | 30 Participants |
| Current Services Utilized by Families to Support Children at autism-likelihood Survey Caregivers who had received a diagnostic or intervention referral before Family Care Project | 5 Participants | — | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 6 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 4 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Female | 35 Participants | 6 Participants | 41 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Staff Competence in Assisting Families with Children at-autism Likelihood Survey (self-report) | — | 4.70 score on a scale STANDARD_DEVIATION 0.47 | 4.70 score on a scale STANDARD_DEVIATION 0.47 |
| The Maternal Self-Efficacy Scale Questionnaire | 3.28 score on a scale STANDARD_DEVIATION 0.74 | — | 3.28 score on a scale STANDARD_DEVIATION 0.74 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
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
Population: Caregivers who completed Family Care Project and completed the survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Family Care Project Workbook-caregivers | Caregiver Knowledge and Use of Behaviors That Support Children at Autism-likelihood Survey | 4.46 score on a scale | Standard Deviation 0.55 |
p-value: <0.01t-test, 2 sided
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.
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
Population: Caregivers who completed the Family Care Project and survey.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Family Care Project Workbook-caregivers | Current Services Utilized by Families to Support Children at Autism-likelihood Survey | Caregivers who connected with diagnostic intervention services for their child | 17 Participants |
| Family Care Project Workbook-caregivers | Current Services Utilized by Families to Support Children at Autism-likelihood Survey | Caregivers who did not get connected with local developmental or autism services | 18 Participants |
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
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
Population: Caregivers and non-specialist providers who completed the surveys. All participated in Family Care Project (either received it or delivered it).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Family Care Project Workbook-caregivers | Family Care Project Feedback Survey of Implementation Properties | Appropriateness | 4.23 score on a scale | Standard Deviation 0.72 |
| Family Care Project Workbook-caregivers | Family Care Project Feedback Survey of Implementation Properties | Acceptability | 4.54 score on a scale | Standard Deviation 0.6 |
| Family Care Project Workbook-nonspecialist Providers | Family Care Project Feedback Survey of Implementation Properties | Appropriateness | 4.56 score on a scale | Standard Deviation 0.62 |
| Family Care Project Workbook-nonspecialist Providers | Family Care Project Feedback Survey of Implementation Properties | Acceptability | 4.78 score on a scale | Standard Deviation 0.43 |
| Family Care Project Workbook-nonspecialist Providers | Family Care Project Feedback Survey of Implementation Properties | Feasibility | 4.67 score on a scale | Standard Deviation 0.49 |
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
Time frame: 1 week after implementation of Family Care Project with pilot families
Population: All non-specialist providers who delivered Family Care Project to caregivers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Family Care Project Workbook-nonspecialist Providers | Staff Competence in Assisting Families With Children At-autism Likelihood Survey (Self-report) | 4.73 score on a scale | Standard Deviation 0.26 |
p-value: 0.34t-test, 2 sided
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.
Time frame: 1 week after staff complete training in Family Care Project, which is 1 week before the pilot commences
Population: 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.
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
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
Population: Caregivers who completed the Family Care Project and the maternal self-efficacy survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Family Care Project Workbook-caregivers | The Maternal Self-Efficacy Scale Questionnaire | 3.48 score on a scale | Standard Deviation 0.51 |
p-value: 0.05t-test, 2 sided