Culturally-Responsive Curriculum for Caregivers With Children at Autism Likelihood

Autism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06314438
• Other study ID #: STUDY00017189
• Secondary ID: UL1TR002319
• Status: Completed
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Development Delay

Intervention

Behavioral:
• Family Care Project
Caregivers will be administered the Family Care Project workbook.

Locations

Country	Name	City	State
United States	Mother Africa	Kent	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 week after staff complete training in Family Care Project, which is 1 week before the pilot commences
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.	1 week before and 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.	The first session of the Family Care Project and the last session of the Family Care Project, which is separated by 4-6 weeks depending on family preference
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.	The first session of the Family Care Project and the last session of the Family Care Project, which is separated by 4-6 weeks depending on family preference
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.	The first session of the Family Care Project and the last session of the Family Care Project, which is separated by 4-6 weeks depending on family preference
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.	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