FASTT Telehealth Behavioral Support Service for Caregivers of Children With Developmental Delay or Disability

NCT05909670 | Completed

• 1 other identifier: R41HD111097
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

Over 7 million children in the U.S. receive support for a developmental delay or disability (DD). For caregivers of these children, behavior issues that often accompany their child's condition create high levels of stress leading to increased mental and physical health issues and impacts on caregiver-child interactions and family functioning. Although evidence-based practices exist to help caregivers with their child's behavioral development, access to these services is often limited by rigid delivery models requiring in-person visits that can delay support and further increase the burden on families. These barriers are disproportionately higher for families of color and for those in low resource situations: an effect that has been exacerbated by reductions in services due to coronavirus disease 2019 (COVID-19). The overall objective of this project is to develop and implement a telehealth delivery model of rapid-response, evidence-based behavioral support to be provided in conjunction with an existing family navigation program (Undivided) serving parents of children with DD to create a commercially marketable product that will reduce barriers to services in local communities across the country. This project will test the feasibility and acceptability of the Family Advice Text and Telephone (FASTT) support service for caregivers of young children. This Phase 1 application will enable a collaborative process to adapt evidence-based behavioral support to the specific needs of families of children ages birth to 12 with DD and integrate that support within the existing family navigation service. The rationale for the work is that providing effective, personalized support through the widely accessible mediums of text and telephone will get caregivers the help they need when and where they have time to access it and close in time to the behavioral issues they need help with, thus reducing caregiver stress and increasing their sense of competence and positive interactions with their child. Aim 1 determines the feasibility of delivering evidence-based behavioral support to caregivers of children with disabilities using on-demand text messaging. Aim 2 gauges the acceptability of the text-based support service to caregivers. Aim 3 assesses the extent to which text-based support reduces caregiver stress, improves caregiver sense of competence, and builds more positive perceptions of their child's behavior and their relationship with their child.

Conditions

Parent-Child Relations; Parenting; Child Behavior; Development Delay; Developmental Disability; Development Disorder, Child

Keywords

caregiving; family navigation; child-centered; strength-based; telehealth; text-based support

Outcome Measures

Primary Outcomes (2)

• Service engagement percentage as assessed by recruitment and consent records

  This measure will include the number of families who opted to engage in the program as a percentage of the total number of families offered participation.

  Through study completion: an average of 1 year.

• Program acceptability rating questionnaire

  This measure will be the average of 3 questionnaire items that assess caregivers' satisfaction with the service (e.g., ratings of the degree to which participants found the program useful, easy to access, and respectful of their values). Participant responses will be captured using 7-point Likert scale, with "1" indicating extremely dissatisfied and "7" indicating extremely satisfied.

  Through study completion: an average of 1 year.

Secondary Outcomes (2)

• Parenting Stress Index 4 - Short Form (PSI)

  Through study completion: an average of 1 year.

• Parenting Sense of Competency Scale (PSOC)

  Through study completion: an average of 1 year.

Study Arms (1)

Phase 1 intervention

EXPERIMENTAL

Families will receive text and telephone support for child behavior and parenting stress issues.

Behavioral: Family Advice and Support Text and Telephone (FASTT) program

Interventions

Family Advice and Support Text and Telephone (FASTT) program BEHAVIORAL

The Family Advice Support Text and Telephone (FASTT) service is a telehealth model that provides on-demand, evidence-based advice and support to reduce child behavior problems, address concerns about child development, and help manage stress for caregivers of children with DD. By using text and telephone, which are widely available without disparities in access by race, ethnicity, or socioeconomic status, FASTT overcomes barriers associated with videoconferencing which requires dependable Internet and familiarity with technology use. FASTT allows support to be delivered at times and locations that are convenient for the caregiver.

Phase 1 intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a caregiver of a child age birth to 12 years with a developmental delay or disability
• Must understand spoken and written English sufficiently to complete survey questions and engage in the support program
• Must live within the State of California (i.e. the service area for the family navigation service conducting the project).
• Must have access to a phone or other device with text or voice capability. Note: Internet access is not required.

Sponsors & Collaborators

• University of Oregon: lead
• Special X Inc.: collaborator

Study Sites (2)

Special X Inc., dba Undivided

Los Angeles, California, 90064, United States

Location

University of Oregon

Eugene, Oregon, 97403-1227, United States

Location

Related Publications (18)

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  PMID: 27801721 BACKGROUND

• Neece C, McIntyre LL, Fenning R. Examining the impact of COVID-19 in ethnically diverse families with young children with intellectual and developmental disabilities. J Intellect Disabil Res. 2020 Oct;64(10):739-749. doi: 10.1111/jir.12769. Epub 2020 Aug 18.

  PMID: 32808424 BACKGROUND

• Jeste S, Hyde C, Distefano C, Halladay A, Ray S, Porath M, Wilson RB, Thurm A. Changes in access to educational and healthcare services for individuals with intellectual and developmental disabilities during COVID-19 restrictions. J Intellect Disabil Res. 2020 Nov;64(11):825-833. doi: 10.1111/jir.12776. Epub 2020 Sep 17.

  PMID: 32939917 BACKGROUND

• Razai MS, Oakeshott P, Kankam H, Galea S, Stokes-Lampard H. Mitigating the psychological effects of social isolation during the covid-19 pandemic. BMJ. 2020 May 21;369:m1904. doi: 10.1136/bmj.m1904. No abstract available.

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  PMID: 32985703 BACKGROUND

• Morgenstern J, Kuerbis A, Houser J, Levak S, Amrhein P, Shao S, McKay JR. Dismantling motivational interviewing: Effects on initiation of behavior change among problem drinkers seeking treatment. Psychol Addict Behav. 2017 Nov;31(7):751-762. doi: 10.1037/adb0000317. Epub 2017 Sep 28.

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  PMID: 20423957 BACKGROUND

• Dunst CJ, Raab M, Hamby DW. Contrasting approaches to the response-contingent learning of young children with significant delays and their social-emotional consequences. Res Dev Disabil. 2017 Apr;63:67-73. doi: 10.1016/j.ridd.2017.02.009. Epub 2017 Mar 6.

  PMID: 28268201 BACKGROUND

• Mottron L. Should we change targets and methods of early intervention in autism, in favor of a strengths-based education? Eur Child Adolesc Psychiatry. 2017 Jul;26(7):815-825. doi: 10.1007/s00787-017-0955-5. Epub 2017 Feb 8.

  PMID: 28181042 BACKGROUND

• Waters L, Sun J. Can a Brief Strength-Based Parenting Intervention Boost Self-Efficacy and Positive Emotions in Parents. International Journal of Applied Positive Psychology 2016; 1, 41-56. https://doi.org/10.1007/s41042-017-0007-x

  BACKGROUND

• Haskett ME, Ahern LS, Ward CS, Allaire JC. Factor structure and validity of the parenting stress index-short form. J Clin Child Adolesc Psychol. 2006 Jun;35(2):302-12. doi: 10.1207/s15374424jccp3502_14.

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  PMID: 12149976 BACKGROUND

• Zaidman-Zait A, Mirenda P, Zumbo BD, Wellington S, Dua V, Kalynchuk K. An item response theory analysis of the Parenting Stress Index-Short Form with parents of children with autism spectrum disorders. J Child Psychol Psychiatry. 2010 Nov;51(11):1269-77. doi: 10.1111/j.1469-7610.2010.02266.x.

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• Johnston C, Mash EJ. A measure of parenting satisfaction and efficacy. Journal of clinical child psychology 1989; 18, 167-175.

  BACKGROUND

• Gerald B. A Brief Review of Independent, Dependent and One Sample t-test. International Journal of Applied Mathematics and Theoretical Physics 2018; 4, 50. https://doi.org/10.11648/j.ijamtp.20180402.13

  BACKGROUND

• Lowry R. Subchapter 12a: The Wilcoxon signed rank test. VassarStats: Website for statistical computation. Retrieved July 2000; 20, http://facultysites.vassar.edu/lowry/PDF/c12a.pdf

  BACKGROUND

• Marsden E, Torgerson CJ. Single group, pre- and post-test research designs: Some methodological concerns. Oxford Review of Education 2012; 38, 583-616. https://doi.org/10.1080/03054985.2012.731208

  BACKGROUND

MeSH Terms

Conditions

Child Behavior; Learning Disabilities; Developmental Disabilities

Condition Hierarchy (Ancestors)

Behavior; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Shannon Peake, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Caregivers of children will complete pre- and post-program assessments to determine the feasibility and acceptability of the intervention and exploratory effects on self-reported parenting stress and parenting sense of competence.

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 18, 2023
• Study Start: April 25, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Eligible individual participant data will be made available 1-year after the study is complete
• Access Criteria: Individual participant data access requests must be approved by the study's Principal Investigator. Requests should include information about who will be given access to the individual participant data and what the individual participant data will be used for. If approved, a Data Use Agreement (DUA) will need to be completed between the University of Oregon and the institution where the individual participant data will be sent.

Locations

US (2)