Culturally-Responsive Curriculum for Caregivers With Children at Autism Likelihood

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism; Development Delay
• Intervention / Treatment: Behavioral: Family Care Project

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kent, Washington, United States, 98032
      • Mother Africa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Care Project workbook; Caregivers will be administered the Family Care Project workbook.	Behavioral: Family Care Project; Caregivers will be administered the Family Care Project workbook.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	1 week before and 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.	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
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
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
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Wendy L Stone, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): March 15, 2024
• Study Completion (Estimated): March 15, 2024

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: STUDY00017189; UL1TR002319 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No