Culturally-Responsive Curriculum for Caregivers With Children at Autism Likelihood

NCT06314438 | Completed Results

• 2 other identifiers: STUDY00017189UL1TR002319
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Development Delay

Outcome Measures

Primary Outcomes (6)

• 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 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

  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. 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

  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

• 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

  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

• 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.

  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

• 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

  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

Study Arms (1)

Family Care Project workbook

EXPERIMENTAL

Caregivers will be administered the Family Care Project workbook.

Behavioral: Family Care Project

Interventions

Family Care Project BEHAVIORAL

Caregivers will be administered the Family Care Project workbook.

Family Care Project workbook

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Mother Africa

Kent, Washington, 98032, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Learning Disabilities

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Principal Investigator
• Organization: University of Washington

stonew@uw.edu

206-221-3595

Study Officials

• Wendy L Stone, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Fellow, School of Medicine: Pediatrics

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: March 18, 2024
• Study Start: December 15, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: May 4, 2025
• Results First Posted: May 4, 2025

Record last verified: 2025-04

Locations

US (1)