Clinical trial NCT05336955: Evaluation of Telehealth Services on Mental Health Outcomes for People With Intellectual and Developmental Disabilities
Official title: Evaluation of Telehealth Services on Mental Health Outcomes for People With Intellectual and Developmental Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Conditions
Developmental Disability
Lead sponsor: University of New Hampshire
Sponsor class: OTHER
Collaborators: name: University of Florida
name: Georgetown University
name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Patient-Centered Outcomes Research Institute
First posted: 2022-04-20
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Aim 1: Refine START (Systemic, Therapeutic, Assessment, Resources, and Treatment) telemental health practices to meet the needs of persons with IDD and mental health needs, their family caregivers, and providers.

The primary goal of Aim 1 is to identify strengths and weaknesses of telemental health START practices to inform the patient-centered intervention protocols used in Aim 2. The investigators hypothesize that our engagement approach and the qualitative methods used to design the telemental protocols will result in telemental health services that are accessible, acceptable, and inclusive in response to the diverse community of people with IDD-MH and their families.

The secondary goal of Aim 1 is to design the Person Experiences Interview Survey (PEIS), adapted from the gold-standard Family Experiences Interview Schedule (FEIS). The investigators hypothesize that our engagement approach and the qualitative methods used to design the Person Experiences Interview Survey (PEIS) will result in a self-report tool with content validity for youth and young adults with IDD and mental health service experiences as indicated by the relevance, comprehensiveness, and ease of understanding.

Aim 2: Compare the effectiveness of in-person START practices versus START telemental health using a randomized control design.

It is hypothesized that telemental health START will not be inferior to in-person START in the reduction of emergency psychiatric service use, time-to-discharge, and improvement in mental health stability and perceived quality of care. This finding will support the use of telemental health practices as a valuable alternative to in-person care.

Aim 3: Evaluate heterogeneity of treatment response by assessing differences in outcomes (emergency service diversion, perceived quality of care, and mental health stability) across diverse groups (e.g., race, ethnicity, language spoken, rural settings, level of intellectual disability).

It is hypothesized that study outcomes (emergency service use, quality of care, and mental health stability) will not be inferior for the telemental health condition compared to the in- person condition within or across diverse groups, except for those living in rural settings. The investigators hypothesize improved outcomes will be found among those in the telemental health condition who live in a rural setting, compared to those living in a rural setting who are in the in-person condition, given the known difficulty in accessing in-person services for those living far from care. This finding will support equitable effects of telemental health START practices among diverse racial/ethnic and developmental groups, with potential added value for those living in rural settings.

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion:

* None

Primary outcomes:
measure: Change in Family Experiences Interview Schedule (FEIS) over 1 year
timeFrame: Change in FEIS scores [at 2 timepoints: enrollment, and 1 year (or discharge)]
Secondary outcomes:
measure: Change in Aberrant Behavior Checklist (ABC) at 1 year
timeFrame: Change in ABC scores [at 3 timepoints: enrollment, 6 months, and 1 year (or discharge)]
measure: Change in Crisis Service Use at 1 year
timeFrame: Change between enrollment to 1 year (or discharge)
measure: Time to discharge
timeFrame: continuous monitoring up to 1 year
measure: Change in mental health stability as measured by START Plan scores at 1 year
timeFrame: Change in START plan scores [at 3 timepoints: enrollment, 6 months, and 1 year (or discharge)
Other outcomes:
Locations:
city: Concord
country: United States
facility: NC West
state: North Carolina
Study officials:
affiliation: University of New Hampshire
name: Joan B Beasley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.