Evaluation of Telehealth Services on Mental Health Outcomes for People With Intellectual and Developmental Disabilities

NCT05336955 | Recruiting DMC

• 2 other identifiers: UNH-08-FY2023-2-01UNH IRB-FY2022-232
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Roughly 40% of those with intellectual and developmental disabilities (IDD) have mental health needs, which is twice the national average. Nevertheless, there is dearth of evidenced-based mental health treatment for youth and young adults with IDD. The disparity in access to mental health care places those with IDD at greater risk of crisis service use. While telemental health studies demonstrate potential to enhance access to care, little of this research includes those with IDD, or crisis prevention and intervention. This project will refine and evaluate telemental health services for youth and young adults with IDD delivered within START (Systemic, Therapeutic, Assessment, Resources, and Treatment), a national, evidence-based model of crisis prevention and intervention for people with IDD. The study will begin with stakeholder feedback (service recipients, families, and providers) regarding telemental health services (Aim 1). Results will be used to refine the intervention. Our team will then compare telemental health versus in-person START services in a randomized control trial (Aim 2). To our knowledge, this will be the first trial of a telemental health crisis program for the IDD population. The final goal is to understand if outcomes vary across subpopulations (Aim 3) and to identify potential disparities. If found, the investigators will work with service users, families and providers to develop a strategy to address identified disparities in outcomes. The study will be executed by an interdisciplinary team of experts engaged with stakeholder partners. Understanding the benefits of specific telemental health methods has important implications to the design of interventions, within and outside of START. This telemental health study offers promise to address disparities in access to mental health care for people with IDD.

Conditions

Mental Health Conditions; Developmental Disability

Outcome Measures

Primary Outcomes (1)

• Change in Family Experiences Interview Schedule (FEIS) over 1 year

  A semi-structured interview of caregiver experiences with the mental health system

  Change in FEIS scores [at 2 timepoints: enrollment, and 1 year (or discharge)]

Secondary Outcomes (4)

• Change in Aberrant Behavior Checklist (ABC) at 1 year

  Change in ABC scores [at 3 timepoints: enrollment, 6 months, and 1 year (or discharge)]

• Change in Crisis Service Use at 1 year

  Change between enrollment to 1 year (or discharge)

• Time to discharge

  continuous monitoring up to 1 year

• Change in mental health stability as measured by START Plan scores at 1 year

  Change in START plan scores [at 3 timepoints: enrollment, 6 months, and 1 year (or discharge)

Study Arms (2)

Telemental health START

EXPERIMENTAL

Telemental health START will deliver two components via telephonic or other communication technology (e.g., Zoom). This includes component #2 (consultation and coping skills coaching) and component #4 (service linkages, referrals, outreach, \& training). START components #1 (intake and quarterly assessment) and #3 (24-hour urgent crisis response and intervention) will continue to be provided in-person.

Other: Intake and quarterly assessment:; Other: Consultation & coping skills coaching:; Other: 24-hour urgent crisis response and intervention:; Other: Service linkages, referrals, outreach, & training:

In-person START

ACTIVE COMPARATOR

In-person START will deliver all model components in-person. This is the established model.

Other: Intake and quarterly assessment:; Other: Consultation & coping skills coaching:; Other: 24-hour urgent crisis response and intervention:; Other: Service linkages, referrals, outreach, & training:

Interventions

Intake and quarterly assessment: OTHER

The START Plan is designed to evaluate the mental health needs of persons with IDD and measure the capacity of the formal and natural support systems. Family caregivers, or the person primarily responsible for day-to-day care of the person, participate in a formatted interview conducted by START coordinators. The START coordinator completes the initial START Plan during intake and quarterly thereafter. Based on informant responses, an intensity rating is assigned to determine the type, frequency, and duration of services to be provided. Quarterly assessment is conducted to inform development or modification of the Cross-Systems Crisis Prevention and Intervention Plan (D.2.b.2.). Hypothesized causal pathway: Family caregiver engagement in assessment enables the START team to efficiently and effectively identify needs and socially valid solutions that strategically reduce use of emergency services and increase mental health stability.

In-person START; Telemental health START

Consultation & coping skills coaching: OTHER

Mental health service consultation is provided by START clinical and medical directors in order to prevent and de-escalate crises. Coping skills coaching, provided by START coordinators, helps to determine with the person, their family, and the system of care how to promote well-being and stability. Successful coping skills for the person are incorporated into the Cross-Systems Crisis Prevention and Intervention Plan. All methods are manualized and reported to meet model fidelity. Hypothesized causal pathway: Providing consultation and coping skills coaching to youth and young adults with IDD, their families, and their system of care increases capacity for crisis prevention and stabilization, reduces emergency service use, and increases quality of care, leading to long-term stability.

In-person START; Telemental health START

24-hour urgent crisis response and intervention: OTHER

START teams have 24-hour, in-person mobile crisis intervention services. Emergency calls come from a variety of sources; clients, emergency rooms, service providers, families, and law enforcement. START provides immediate telephonic response and in-person evaluation within two hours of the initial contact. Hypothesized causal pathway: Real-time, immediate support enables the successful enactment of crisis evaluation and stabilization. This reduces severity of the crises and allows for diversion from emergency service use.

In-person START; Telemental health START

Service linkages, referrals, outreach, & training: OTHER

START teams work with stakeholders to develop and maintain linkage agreements. The purpose of these agreements is to enhance the capacity of the system as a whole and develop partnerships to reduce disparities and gaps in the service array. START coordinators conduct crisis prevention-focused outreach visits with the person and/or their system of care. Examples include training during home- and school-based visits, family caregiver coaching to implement new plans or strategies, and checking in with the person to monitor their level of stability. Hypothesized causal pathway: Increased person-centered collaboration and dialogue across systems of care promotes patient perceived quality of care, the identification of more effective strategies that support their mental health needs, and results in reduced use of emergency services.

In-person START; Telemental health START

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• participant age 12-45 years
• Lives in family setting
• New START enrollee (within 90 days of enrollment)
• Enrolled at an eligible START site
• Able to obtain informed consent.

You may not qualify if:

• None

Sponsors & Collaborators

• University of New Hampshire: lead
• University of Florida: collaborator
• Georgetown University: collaborator
• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

NC West

Concord, North Carolina, 28025, United States

RECRUITING

Related Publications (5)

• Kalb LG, Beasley JB, Caoili A, McLaren JL, Barnhill J. Predictors of Mental Health Crises Among Individuals With Intellectual and Developmental Disabilities Enrolled in the START Program. Psychiatr Serv. 2021 Mar 1;72(3):273-280. doi: 10.1176/appi.ps.202000301. Epub 2020 Dec 18.

  PMID: 33334153 BACKGROUND

• Holingue C, Kalb LG, Klein A, Beasley JB. Experiences With the Mental Health Service System of Family Caregivers of Individuals With an Intellectual/Developmental Disability Referred to START. Intellect Dev Disabil. 2020 Oct 1;58(5):379-392. doi: 10.1352/1934-9556-58.5.379.

  PMID: 33032318 BACKGROUND

• Kalb LG, Beasley J, Caoili A, Klein A. Improvement in Mental Health Outcomes and Caregiver Service Experiences Associated With the START Program. Am J Intellect Dev Disabil. 2019 Jan;124(1):25-34. doi: 10.1352/1944-7558-124.1.25.

  PMID: 30715923 BACKGROUND

• Kalb LG, Beasley J, Klein A, Hinton J, Charlot L. Psychiatric hospitalisation among individuals with intellectual disability referred to the START crisis intervention and prevention program. J Intellect Disabil Res. 2016 Dec;60(12):1153-1164. doi: 10.1111/jir.12330. Epub 2016 Aug 26.

  PMID: 27561378 BACKGROUND

• Kalb LG, Kramer JM, Goode TD, Black SJ, Klick S, Caoili A, Klipsch S, Klein A, Urquilla MP, Beasley JB. Evaluation of telemental health services for people with intellectual and developmental disabilities: protocol for a randomized non-inferiority trial. BMC Health Serv Res. 2023 Jul 25;23(1):795. doi: 10.1186/s12913-023-09663-6.

  PMID: 37491216 DERIVED

MeSH Terms

Conditions

Developmental Disabilities

Interventions

Referral and Consultation; Methods

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Investigative Techniques

Study Officials

• Joan B Beasley, PhD

  University of New Hampshire

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan B Beasley, PhD

CONTACT

866-807-0987; start.telehealthstudy@unh.edu

Andrea Caoili, MSW

CONTACT

866-807-0987; start.telehealthstudy@unh.edu

Study Design

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

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 20, 2022
• Study Start: May 1, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 7 years post study
• Access Criteria: none. The full data package, including the IPD, will be made publicly available in the PCORI registry, as listed below.

Locations

US (1)