An interventional study of Intake and quarterly assessment: and Consultation & coping skills coaching: in Mental Health Conditions and Developmental Disability, sponsored by University of New Hampshire. Active, not recruiting at 1 site in United States. Open to participants aged 12 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by University of New Hampshire · Not applicable, Interventional, and Treatment
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.
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.
230 studies on the registry are indexed under Developmental Disabilities; 65 are open to participants now.
This study's enrollment of 339 is above the median of 60 across 150 interventional studies indexed under Developmental Disabilities.
Browse Developmental Disabilities studies →University of New Hampshire is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
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Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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:
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.
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.
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.
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.
Change in Family Experiences Interview Schedule (FEIS) over 1 year
A semi-structured interview of caregiver experiences with the mental health system
Time frame: Change in FEIS scores [at 2 timepoints: enrollment, and 1 year (or discharge)]
Change in Aberrant Behavior Checklist (ABC) at 1 year
Mental health symptom checklist
Time frame: Change in ABC scores [at 3 timepoints: enrollment, 6 months, and 1 year (or discharge)]
Change in Crisis Service Use at 1 year
Number (and outcomes) fo contacts with the START. This outcome is continuously monitored.
Time frame: Change between enrollment to 1 year (or discharge)
Time to discharge
Number of days enrolled up to 1 year
Time frame: continuous monitoring up to 1 year
Change in mental health stability as measured by START Plan scores at 1 year
The START Plan is a custom measure developed by and for the START project. It is a multi-informant measure of mental health and service stability. It is conducted by the START coordinator using their observations and input from primary caregivers or appropriate professional staff. Specifically, it has three sections. Section A is a historical report of mental health challenges. Section B is the level of intensity and risk of mental health challenge. Section C assesses quality of perceived professional and community supports, from both the coordinator and informant perspectives.
Time frame: Change in START plan scores [at 3 timepoints: enrollment, 6 months, and 1 year (or discharge)
Plan to share: Yes — The full data package will be maintained and made publicly available for at least 7 years. Individual Participant data (IPD) will be made publicly available after full de-identification. It will be included in the full data package. The full data package includes the de-identified IPD, full study protocol, data handbook, data dictionary, full statistical analysis plan (including all amendments and all documentation for additional work processes), and analytic code. Analytic code will be written in STATA 15.0 (College Station, Tx). Dr. Kalb (Co-PI) will serve as the contact for third party use. The full data package will be shared via PCORI's designated registry.
Supporting information: Study protocol, Statistical analysis plan, 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.
Data sharing details ↗ · www.icpsr.umich.edu
Started May 2023 (actual). Primary completion is estimated for Jan 2027, 44 months after the start.
Of 96 non-industry interventional studies with no phase under Developmental Disabilities, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 49. This study's planned 44 months is above that.
Counting every sponsor, half of 97 studies reached it within 22 months; a quarter within 13 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of New Hampshire