Culturally-Responsive Curriculum for Caregivers With Children at Autism Likelihood

NCT ID: NCT06314438

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2024-03-15

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.

Conditions

Autism; Development Delay

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Family Care Project workbook

Caregivers will be administered the Family Care Project workbook.

Group Type: EXPERIMENTAL

Family Care Project

Intervention Type: BEHAVIORAL

Caregivers will be administered the Family Care Project workbook.

Interventions

Family Care Project

Caregivers will be administered the Family Care Project workbook.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Hannah Benavidez

Graduate Fellow, School of Medicine: Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wendy L Stone, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Mother Africa

Kent, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UL1TR002319

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00017189

Identifier Type: -

Identifier Source: org_study_id