Telehealth Mental Health Support for Developmental Disabilities

Overseen By Andrea Caoili, MSW

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of New Hampshire

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Telehealth Mental Health Support for Developmental Disabilities?

Research shows that crisis intervention programs, like those in hospitals, can reduce the need for inpatient psychiatric admissions and save costs. Additionally, involving family in crisis resolution can lead to better outcomes, as seen in a study where patients with family involvement were more likely to be discharged quickly. ^{1 2 3 4 5}

Is telehealth mental health support for developmental disabilities generally safe for humans?

Research on crisis intervention services, which include telehealth mental health support, suggests they are generally safe for humans. These services are designed to provide immediate help during mental health crises and have been used effectively in various settings, indicating a good safety profile. ^{6 7 8 9 10}

How is the 24-hour urgent crisis response and intervention treatment unique for mental health support in developmental disabilities?

This treatment is unique because it offers immediate, around-the-clock crisis support through telehealth, ensuring accessibility and continuous contact until the crisis is resolved, which is different from traditional mental health models that may not provide such immediate and ongoing support. ^{9 11 12 13 14}

Research Team

Joan B Beasley, PhD

Principal Investigator

University of New Hampshire

Eligibility Criteria

This trial is for young individuals aged 14-35 with intellectual and developmental disabilities who live at home with family. They must be new enrollees in the START program within 90 days of joining, and able to give informed consent.

Inclusion Criteria

I am between 12 and 45 years old.

Enrolled at an eligible START site

Lives in family setting

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Refinement and Stakeholder Feedback

Refinement of telemental health practices based on stakeholder feedback to meet the needs of persons with IDD and mental health needs, their family caregivers, and providers.

8 weeks

Multiple virtual feedback sessions

Randomized Control Trial

Comparison of the effectiveness of in-person START practices versus START telemental health using a randomized control design.

12 months

Regular virtual and in-person sessions

Follow-up

Participants are monitored for changes in mental health stability, crisis service use, and quality of care.

12 months

Continuous monitoring with assessments at enrollment, 6 months, and 1 year

Treatment Details

Interventions

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

Trial Overview The study tests telemental health services versus in-person care within the START model, focusing on crisis prevention and intervention for those with IDD. It includes stakeholder feedback, a randomized control trial, and analysis of outcomes across subpopulations.

Participant Groups

Group I: Telemental health START Experimental Treatment 4 Interventions

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.

Group II: In-person START Active Control 4 Interventions

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

24-hour urgent crisis response and intervention is already approved in United States for the following indications:

Approved in United States as 24-hour Urgent Crisis Response and Intervention for:

• Mental health crisis intervention for individuals with intellectual and developmental disabilities

Who Is Running the Clinical Trial?

University of New Hampshire

Lead Sponsor

Trials

16

Recruited

105,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Collaborator

Trials

93

Recruited

25,200+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

The after-hours crisis intervention program at a Veterans Affairs hospital, staffed by psychiatric residents, successfully reduced inpatient psychiatric admissions by 34% during its first year.

This reduction in admissions resulted in significant cost savings of nearly $400,000 in inpatient treatment expenses, highlighting the program's efficacy in managing psychiatric crises effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric crisis intervention in the general emergency service of a Veterans Affairs hospital. Lambert, M.[2018]

In a study of 136 patients admitted to a three-day crisis resolution unit, 19% were successfully discharged within 72 hours, indicating the unit's potential for effective short-term intervention.

Family involvement in treatment was significantly higher among patients who were discharged (77%) compared to those who required further hospitalization (28%), suggesting that including family in the therapeutic process may enhance recovery outcomes, especially for psychotic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three day crisis resolution unit. Dubin, SE., Ananth, J., Bajwa-Goldsmith, B., et al.[2021]

In a study of 136 patients admitted to a three-day crisis resolution unit, 49% were successfully discharged within 72 hours, indicating the unit's effectiveness in providing timely intervention for psychiatric emergencies.

Family involvement in treatment was significantly higher among patients who were discharged (77%) compared to those who required further hospitalization (28%), suggesting that including family members in the therapeutic process may enhance recovery outcomes, especially for psychotic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three day crisis resolution unit. Dubin, SE., Ananth, J., Bajwa-Goldsmith, B., et al.[2021]

This study will evaluate the effectiveness of a service improvement program for crisis resolution teams (CRTs) across 25 teams in England, focusing on enhancing user satisfaction and service quality over a 1-year period.

The primary outcome will be service user satisfaction with CRT care, while secondary outcomes will include hospital admission rates and staff well-being, providing a comprehensive assessment of the program's impact on both users and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CORE Service Improvement Programme for mental health crisis resolution teams: study protocol for a cluster-randomised controlled trial. Lloyd-Evans, B., Fullarton, K., Lamb, D., et al.[2022]

Recent advances in rapid neuroleptization techniques allow psychiatric emergency staff to stabilize acutely ill patients in under 24 hours, reducing the need for hospital admissions.

The psychiatric emergency unit acts as a central hub for coordinating various alternative care options, ranging from family support to crisis bed units, which helps improve follow-up care and reduces unnecessary institutionalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The psychiatric emergency/crisis disposition and community networks. Campos, DT., Gieser, MT.[2019]

In a review of a crisis intervention program for 267 individuals with developmental disabilities and dual diagnoses, 69% only needed one intervention, indicating the program's effectiveness in addressing crises.

For the 31% who required multiple interventions, most were re-referred within two years, highlighting the ongoing need for support and the importance of a coordinated community-based mental health system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crisis intervention for community-based individuals with developmental disabilities and behavioral and psychiatric disorders. Davidson, PW., Cain, NN., Sloane-Reeves, JE., et al.[2011]

The Central Institute of Mental Health has provided a 24-hour crisis intervention and emergency service since 1976, treating approximately 1,800-1,900 episodes annually, primarily for mental health issues, with over 50% of users being mentally ill.

Suicidal attempts or intentions, marriage crises, and alcohol problems each account for about 25-30% of the service users, highlighting the critical need for immediate medical and social support in psychiatric emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychiatric emergency care and crisis intervention--concepts, experiences and results]. Häfner, H., Rössler, W., Haas, S.[2018]

Over a 3-year period, a community-based crisis intervention team managed 326 psychiatric emergencies, with a notable increase in patients presenting with acute psychosis.

The home treatment approach proved effective for many patients, including those who had previously been hospitalized, suggesting that community-based interventions can successfully address severe psychiatric crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home assessment and treatment in a community psychiatric service. Tufnell, G., Bouras, N., Watson, JP., et al.[2019]

Early intervention and crisis teams are designed to prevent the need for inpatient mental health services by providing accessible and immediate support.

These teams should be mobile and consist of various professionals, maintaining ongoing contact with individuals until their crisis is fully resolved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical management special: mental health. Right on time. Forrest, E.[2016]

A new intervention model was created for adolescents experiencing severe mental health crises, aiming to shorten hospital stays while ensuring high-quality care aligned with the recovery model.

This model could also be beneficial for community teams working with adolescents in crisis, addressing a gap in existing literature on effective crisis intervention for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A crisis recovery model for adolescents with severe mental health problems. Kaplan, T., Racussen, L.[2013]

Yale New Haven Psychiatric Hospital successfully transitioned to telehealth by rapidly implementing virtual intensive outpatient and outpatient group services to continue providing critical mental health care during the COVID-19 pandemic.

The study outlines effective strategies for deploying telehealth services, including clinical protocols and workforce training, which can serve as valuable resources for other healthcare settings facing similar challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency conversion to telehealth in hospital-based psychiatric outpatient services: Strategy and early observations. Childs, AW., Klingensmith, K., Bacon, SM., et al.[2021]

The transition to telehealth during COVID-19 led to a significant increase in telephone contacts (from 45% to 70%) and a dramatic rise in videoconferencing sessions (from 4 to 886), although overall contacts decreased by 13%.

Satisfaction surveys showed that 92% of consumers rated videoconferencing as good or excellent in technical quality, but both consumers and providers faced challenges such as infrastructure issues and privacy concerns, indicating a need for better telehealth platforms and guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth service delivery in an Australian regional mental health service during COVID-19: a mixed methods analysis. Chatterton, ML., Marangu, E., Clancy, EM., et al.[2022]

The Virtual Crisis Care (VCC) program effectively connects rural law enforcement with behavioral health professionals through telehealth, leading to similar recommended and actual outcomes for crisis situations, which helps in managing mental health crises more effectively.

The program likely reduces unnecessary involuntary commitments (IVCs) and is viewed positively by law enforcement, highlighting its ease of use and benefits for individuals in crisis, first responders, and the community overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Partnership Addressing Mental Health Crises: Mixed Methods Study of a Coresponder Program in Rural Law Enforcement. Nataliansyah, MM., Merchant, KAS., Vakkalanka, JP., et al.[2023]

A crisis telephone support service implemented by a Community Mental Health Team during the COVID-19 pandemic was found to be feasible and acceptable, with 77% of the 44 referred participants engaging in the service.

Participants rated the service highly useful, emphasizing that simply 'talking to someone' was the most important aspect, indicating the value of accessible mental health support during crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting to the COVID-19 Pandemic: A Psychological Crisis Support Call Service Within a Community Mental Health Team. Gluckman, NS., Eagle, A., Michalitsi, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Psychiatric crisis intervention in the general emergency service of a Veterans Affairs hospital. [2018]

2. India pubmed.ncbi.nlm.nih.gov

Three day crisis resolution unit. [2021]

3. India pubmed.ncbi.nlm.nih.gov

Three day crisis resolution unit. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The CORE Service Improvement Programme for mental health crisis resolution teams: study protocol for a cluster-randomised controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The psychiatric emergency/crisis disposition and community networks. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Crisis intervention for community-based individuals with developmental disabilities and behavioral and psychiatric disorders. [2011]

7. Germany pubmed.ncbi.nlm.nih.gov

[Psychiatric emergency care and crisis intervention--concepts, experiences and results]. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Home assessment and treatment in a community psychiatric service. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Clinical management special: mental health. Right on time. [2016]

10. England pubmed.ncbi.nlm.nih.gov

A crisis recovery model for adolescents with severe mental health problems. [2013]

11. Ireland pubmed.ncbi.nlm.nih.gov

Emergency conversion to telehealth in hospital-based psychiatric outpatient services: Strategy and early observations. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Telehealth service delivery in an Australian regional mental health service during COVID-19: a mixed methods analysis. [2022]

13. Canada pubmed.ncbi.nlm.nih.gov

Virtual Partnership Addressing Mental Health Crises: Mixed Methods Study of a Coresponder Program in Rural Law Enforcement. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Adapting to the COVID-19 Pandemic: A Psychological Crisis Support Call Service Within a Community Mental Health Team. [2023]