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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve mental health support for young people with intellectual and developmental disabilities (IDD) by testing telehealth services, including 24-hour urgent crisis response and intervention. Researchers seek to determine if telehealth can provide the same benefits as in-person care, particularly in preventing and managing crises. The trial will compare telehealth and in-person services within the START program, which has already proven effective in assisting people with IDD. Eligible candidates include individuals aged 12-45 who have recently joined START and live in a family setting. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mental health support for others 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 prior data suggests that these telemental health methods are safe for youth and young adults with IDD?

Research shows that telemental health services are generally safe and easy to use. Studies have found that receiving mental health care through telehealth is comparable to in-person visits, meaning most patients do not experience more side effects or issues with telehealth.

For this trial, which includes consultations, coaching on coping skills, and assistance in finding other services, research suggests positive outcomes. Most participants report good experiences, and many avoid hospital visits.

In summary, existing research supports the safety of telemental health for mental health care, particularly for individuals with intellectual and developmental disabilities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Mental Health Support for Developmental Disabilities trial because it offers a unique approach to mental health care for individuals with developmental disabilities. Unlike traditional in-person care, the telemental health START program uses telephonic or online communication methods like Zoom to provide critical services such as consultation, coping skills coaching, and service linkages. This innovative delivery method increases accessibility and convenience, making it easier for individuals to receive timely support without the need for travel. Additionally, it integrates technology into mental health care, potentially setting a new standard for how support can be delivered to those with developmental disabilities.

What evidence suggests that this trial's telemental health services could be effective for mental health support in individuals with developmental disabilities?

Research has shown that telemental health services, like those tested in this trial, can assist people with intellectual and developmental disabilities (IDD) in managing their mental health. Participants in the "Telemental health START" arm will receive consultation, coping skills coaching, service linkages, referrals, outreach, and training via telephonic or other communication technology. Studies have found that engaging with a professional and learning coping skills can reduce mental health emergencies and improve overall mental health. This results in fewer emergency room visits for psychiatric issues and better management of mental health conditions. Additionally, connecting individuals to necessary resources can decrease the need for psychiatric hospital stays. As telemental health services advance, they could significantly enhance access to mental health support for those with IDD. ^{1 2 4 6 7}

Who Is on the Research Team?

Joan B Beasley, PhD

Principal Investigator

University of New Hampshire

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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 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]

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]

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]

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]

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