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Completed

NCT Number: NCT06314438

Culturally-Responsive Curriculum for Caregivers With Children at Autism Likelihood

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Communication Disorders Development Delay Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mother Africa

Kent, Washington, 98032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Family Care Project

Behavioral

Caregivers will be administered the Family Care Project workbook.

Primary outcomes

  1. Staff Training Feedback Survey of Implementation Properties (Self-report)

    Time frame: 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.

  2. Staff Competence in Assisting Families With Children At-autism Likelihood Survey (Self-report)

    Time frame: 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

  3. The Maternal Self-Efficacy Scale Questionnaire

    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

    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

  4. Caregiver Knowledge and Use of Behaviors That Support Children at Autism-likelihood Survey

    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

    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

  5. Current Services Utilized by Families to Support Children at Autism-likelihood Survey

    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

    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.

  6. Family Care Project Feedback Survey of Implementation Properties

    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

    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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2024
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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