Trial Outcomes & Findings for Culturally-Responsive Curriculum for Caregivers With Children at Autism Likelihood (NCT NCT06314438)

Last Updated: 2025-05-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

1 week after staff complete training in Family Care Project, which is 1 week before the pilot commences

Results posted on

2025-05-04

Participant Flow

Our community organization recruit eligible families.

No participants were excluded from participation in this study.

Participant milestones

Participant milestones
Measure	Family Care Project Workbook-Caregivers Caregivers will be administered the Family Care Project workbook.	Family Care Project Workbook-nonspecialist Providers Non-specialist providers administered the Family Care Project workbook to caregivers.
Overall Study STARTED	35	6
Overall Study COMPLETED	35	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only includes non-specialist providers who delivered Family Care Project to caregivers. Caregivers did not complete this baseline measure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Family Care Project Workbook-caregivers n=35 Participants Caregivers will be administered the Family Care Project workbook.	Family Care Project Workbook-nonspecialist Providers. n=6 Participants Nonspecialist providers will administer the Family Care Project workbook to caregivers	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=35 Participants	0 Participants n=6 Participants	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=35 Participants	6 Participants n=6 Participants	41 Participants n=41 Participants
Age, Categorical >=65 years	0 Participants n=35 Participants	0 Participants n=6 Participants	0 Participants n=41 Participants
Sex: Female, Male Female	35 Participants n=35 Participants	6 Participants n=6 Participants	41 Participants n=41 Participants
Sex: Female, Male Male	0 Participants n=35 Participants	0 Participants n=6 Participants	0 Participants n=41 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=35 Participants	0 Participants n=6 Participants	0 Participants n=41 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=35 Participants	6 Participants n=6 Participants	41 Participants n=41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=6 Participants	0 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=6 Participants	0 Participants n=41 Participants
Race (NIH/OMB) Asian	5 Participants n=35 Participants	1 Participants n=6 Participants	6 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=6 Participants	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	24 Participants n=35 Participants	4 Participants n=6 Participants	28 Participants n=41 Participants
Race (NIH/OMB) White	6 Participants n=35 Participants	1 Participants n=6 Participants	7 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=6 Participants	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=6 Participants	0 Participants n=41 Participants
Staff Competence in Assisting Families with Children at-autism Likelihood Survey (self-report)	—	4.70 score on a scale STANDARD_DEVIATION 0.47 • n=6 Participants • Only includes non-specialist providers who delivered Family Care Project to caregivers. Caregivers did not complete this baseline measure	4.70 score on a scale STANDARD_DEVIATION 0.47 • n=6 Participants • Only includes non-specialist providers who delivered Family Care Project to caregivers. Caregivers did not complete this baseline measure
The Maternal Self-Efficacy Scale Questionnaire	3.28 score on a scale STANDARD_DEVIATION 0.74 • n=23 Participants • Only includes caregivers who completed the Family Care Project and the maternal self-efficacy survey. Does not include non-specialist providers in study. 12 caregivers did not complete the entire survey and data could not be reported for these caregivers	—	3.28 score on a scale STANDARD_DEVIATION 0.74 • n=23 Participants • Only includes caregivers who completed the Family Care Project and the maternal self-efficacy survey. Does not include non-specialist providers in study. 12 caregivers did not complete the entire survey and data could not be reported for these caregivers
Caregiver Knowledge and Use of Behaviors that Support Children at autism-likelihood Survey	3.81 score on a scale STANDARD_DEVIATION 0.82 • n=20 Participants • Includes only caregivers who completed Family Care Project and completed the survey. Non-specialist providers did not complete this measure. 15 caregivers did not complete the survey in its entirety in order to be reported.	—	3.81 score on a scale STANDARD_DEVIATION 0.82 • n=20 Participants • Includes only caregivers who completed Family Care Project and completed the survey. Non-specialist providers did not complete this measure. 15 caregivers did not complete the survey in its entirety in order to be reported.
Current Services Utilized by Families to Support Children at autism-likelihood Survey Caregivers who had received a diagnostic or intervention referral before Family Care Project	5 Participants n=35 Participants • Includes only caregivers who completed the Family Care Project and survey. Non-specialist providers did not complete this survey.	—	5 Participants n=35 Participants • Includes only caregivers who completed the Family Care Project and survey. Non-specialist providers did not complete this survey.
Current Services Utilized by Families to Support Children at autism-likelihood Survey Caregivers who did not received a diagnostic or intervention referral before Family Care Project	30 Participants n=35 Participants • Includes only caregivers who completed the Family Care Project and survey. Non-specialist providers did not complete this survey.	—	30 Participants n=35 Participants • Includes only caregivers who completed the Family Care Project and survey. Non-specialist providers did not complete this survey.

PRIMARY outcome

Timeframe: 1 week after staff complete training in Family Care Project, which is 1 week before the pilot commences

Population: It was supposed to be non-specialist providers who completed the web-based tutorial (n=6); however, data was not collected properly because there was an issue with the online questionnaire, specifically the Likert scale was presented incorrectly (i.e., the neutral and slightly agree were accidentally combined into "NeutraCompletelyee") and some providers chose this anchor. Therefore, we cannot infer what the providers intended in their selection of this inaccurate anchor.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 week after implementation of Family Care Project with pilot families

Population: All non-specialist providers who delivered Family Care Project to caregivers.

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

Outcome measures

Outcome measures
Measure	Family Care Project Workbook-caregivers Caregivers will be administered the Family Care Project workbook.	Family Care Project Workbook-nonspecialist Providers n=6 Participants Nonspecialist providers will administer the Family Care Project workbook to caregivers.
Staff Competence in Assisting Families With Children At-autism Likelihood Survey (Self-report)	—	4.73 score on a scale Standard Deviation 0.26

PRIMARY outcome

Timeframe: 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

Population: Caregivers who completed the Family Care Project and the maternal self-efficacy survey.

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

Outcome measures

Outcome measures
Measure	Family Care Project Workbook-caregivers n=23 Participants Caregivers will be administered the Family Care Project workbook.	Family Care Project Workbook-nonspecialist Providers Nonspecialist providers will administer the Family Care Project workbook to caregivers.
The Maternal Self-Efficacy Scale Questionnaire	3.48 score on a scale Standard Deviation 0.51	—

PRIMARY outcome

Timeframe: 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

Population: Caregivers who completed Family Care Project and completed the 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

Outcome measures

Outcome measures
Measure	Family Care Project Workbook-caregivers n=20 Participants Caregivers will be administered the Family Care Project workbook.	Family Care Project Workbook-nonspecialist Providers Nonspecialist providers will administer the Family Care Project workbook to caregivers.
Caregiver Knowledge and Use of Behaviors That Support Children at Autism-likelihood Survey	4.46 score on a scale Standard Deviation 0.55	—

PRIMARY outcome

Timeframe: 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

Population: Caregivers who completed the Family Care Project and 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.

Outcome measures

Outcome measures
Measure	Family Care Project Workbook-caregivers n=35 Participants Caregivers will be administered the Family Care Project workbook.	Family Care Project Workbook-nonspecialist Providers Nonspecialist providers will administer the Family Care Project workbook to caregivers.
Current Services Utilized by Families to Support Children at Autism-likelihood Survey Caregivers who connected with diagnostic intervention services for their child	17 Participants	—
Current Services Utilized by Families to Support Children at Autism-likelihood Survey Caregivers who did not get connected with local developmental or autism services	18 Participants	—

PRIMARY outcome

Timeframe: 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

Population: Caregivers and non-specialist providers who completed the surveys. All participated in Family Care Project (either received it or delivered it).

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

Outcome measures

Outcome measures
Measure	Family Care Project Workbook-caregivers n=35 Participants Caregivers will be administered the Family Care Project workbook.	Family Care Project Workbook-nonspecialist Providers n=6 Participants Nonspecialist providers will administer the Family Care Project workbook to caregivers.
Family Care Project Feedback Survey of Implementation Properties Appropriateness	4.23 score on a scale Standard Deviation 0.72	4.56 score on a scale Standard Deviation 0.62
Family Care Project Feedback Survey of Implementation Properties Acceptability	4.54 score on a scale Standard Deviation 0.60	4.78 score on a scale Standard Deviation 0.43
Family Care Project Feedback Survey of Implementation Properties Feasibility	—	4.67 score on a scale Standard Deviation 0.49

Adverse Events

Family Care Project Workbook

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

University of Washington

Phone: 206-221-3595

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place