NCT05099705|CompletedDMC
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Sponsor study identifier
interventional
52
1 country
1
Study Start
July 1, 2022
Actual (reported)Primary Completion
April 16, 2026
Actual (reported)Study Completion
April 16, 2026
Actual (reported)The purpose of this study is to develop and test a family navigator training and an app (a technology-based treatment support system) for low-resourced families of young children (aged 3-5) with autism. The hypothesis is that the navigator training and treatment support system will help enable navigators to support families of young children with autism in accessing needed services.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 16, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 4, 2021
Actual (reported)October 29, 2021
Actual (reported)July 1, 2022
Actual (reported)April 16, 2026
Actual (reported)April 16, 2026
Actual (reported)Change in Knowledge at 9 months
Called the Autism Knowledge Scale, a multi-item measure examining knowledge of autism services. There are 24 items with higher scores indicating more knowledge. Scale ranges from 0-24.
At the pre-survey and at the nine-month survey
Change in Skills at 9 months
Called the Comfort with Advocacy Scale, A multi-item measure examining skills to identify, access, and receive services. There are 12 items with higher scores indicating greater advocacy. Scale ranges from 0 to 60.
At the pre-survey and at the nine-month survey
Change in Advocacy at 9 months
Called the Advocacy Skills Scale, a multi-item measure examining the frequency of advocacy activities. There are nine items with higher scores indicating greater advocacy. Scale ranges from 9 to 45.
At the pre-survey and at the nine-month survey
40 participants will be randomly assigned to the intervention group (i.e., to receive an FSN and have access to the TSS). The FSN may meet with the participant at least twice and provide navigation support.
15 participants will be randomly assigned to the non-personalized comparison group (i.e., information, training, and referral).
An RCT will be conducted. 40 participants will be randomly assigned to the intervention group and 15 participants to the non-personalized comparison group (i.e., information, training, and referral). The intervention group will have access to a navigator and the treatment support system.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Vanderbilt University
Nashville, Tennessee, 37235, United States
Magana, S., et al., Use of promotoras de salud in interventions with Latino families of children with IDD. International Review of Research in Developmental Disabilities, 2014. 47: p. 39-75
Burke, M.M. and S.E. Goldman, Special education advocacy among culturally and linguistically diverse families Journal of Research in Special Educational Needs 2018. 1: p. 3-14.
Maas, C.J. and J.P. Hox, Sufficient sample sizes for multilevel modeling. Methodology, 2005. 1: p. 86- 92.
Meghan Burke, PhD
Vanderbilt University
52 participants (actual enrollment reported by the registry).
First Submitted
October 4, 2021
Pediatric Early Autism Recognition System: PEARS
Change in Empowerment at 9 months
Called the Family Empowerment Scale, aa multi-item measure examining empowerment in family, services, and community/political environments. There are 34 items with higher scores indicating greater empowerment. Scale ranges from 0 to 136.
At the pre-survey and at the nine-month survey
Change in Parenting self-efficacy at 9 months
Called the Self-Efficacy scale, a multi-item measure examining competence in parenting. There are nine items with higher scores indicating greater self-efficacy. Scale ranges from 0 to 36.
At the pre-survey and at the nine-month survey
Change in Service Delivery Outcomes
Called the adapted service measure scale, access to the type, number, and quality of services and unmet service needs. There are over 20 services with higher scores indicating needing greater services. Scale ranges from 0 to 20.
At the pre-survey and at the three-month, six-month, and nine-month survey
Change in Adaptive and maladaptive behavior at 9 months
Called the Vineland Adaptive Behavior Scale, a multi-item measure examining adaptive and maladaptive behavior. There are 100 items with higher scores indicating greater adaptive behavior. Scale ranges from 0 to 100.
At the pre-survey and at the nine-month survey
Change in Social responsiveness at 9 months
Called the Social Responsiveness Scale, a multi-item measure to examine social responsiveness. There are sixty items with higher scores indicating greater social responsiveness. Scale ranges from 0 to 180.
At the pre-survey and at the nine-month survey
Contact the study team to confirm eligibility.
First Posted
October 29, 2021
Study Start
July 1, 2022
Actual (reported)Primary Completion
April 16, 2026
Actual (reported)Study Completion
April 16, 2026
Actual (reported)Last Updated
June 9, 2026
Record last verified: 2026-04
Sharing of data generated by this project will be an important part of the proposed activities of this research and will be carried out in several ways. All research resources developed in this project will be made readily available to the scientific community for non-profit research purposes. The main mechanism for the transfer of information will take the form of peer-reviewed publications and presentations/posters at scientific conferences. Information is collected from participants upon enrollment will be generated to a Global Unique Identifier. Annual reports with de-identified information will be presented to National Institute of Mental Health annually and more often upon request. By the completion of the project, all data will be de-identified and relevant documentation to facilitate data sharing will be available.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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