Mental Health ConditionsNCT05336955
Evaluation of Telehealth Services on Mental Health Outcomes for People With Intellectual and Developmental Disabilities
A study testing Intake and quarterly assessment:, Consultation & coping skills coaching: and 24-hour urgent crisis response and intervention: in people with Mental Health Conditions and Developmental Disability, run by University of New Hampshire at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Mental Health Conditions, Developmental Disability
- What is being tested?
- Intake and quarterly assessment:, Consultation & coping skills coaching: and 24-hour urgent crisis response and intervention:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mental Health Conditions, Developmental Disability
- Being tested
- Intake and quarterly assessment:, Consultation & coping skills coaching:, 24-hour urgent crisis response and intervention:, Service linkages, referrals, outreach, & training:
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Intake and quarterly assessment:; Other: Consultation & coping skills coaching:; Other: 24-hour urgent crisis response and intervention:; Other: Service linkages, referrals, outreach, & training: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Family Experiences Interview Schedule (FEIS) over 1 year
A semi-structured interview of caregiver experiences with the mental health system
Measured: 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
Mental health symptom checklist
Measured: 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.
Measured: Change between enrollment to 1 year (or discharge)
Time to discharge
Number of days enrolled up to 1 year
Measured: 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.
Measured: Change in START plan scores [at 3 timepoints: enrollment, 6 months, and 1 year (or discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 May 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental Health ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Hampshire
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, Georgetown University, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Joan B Beasley, PhD, Principal investigator, University of New Hampshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336955
- Sponsor's protocol ID
- UNH-08-FY2023-2-01
- Other IDs
- UNH IRB-FY2022-232
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 33334153Holingue 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.
PubMed 33032318Kalb 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.
PubMed 30715923Kalb 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.
PubMed 27561378Kalb 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.
PubMed 37491216
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Telehealth Services on Mental Health Outcomes for People With Intellectual and Developmental Disabilities
- ClinicalTrials.gov ID
- NCT05336955
- Acronym / sponsor ID
- UNH-08-FY2023-2-01
- Conditions
- Mental Health Conditions, Developmental Disability
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 339 participants (actual)
- Lead sponsor
- University of New HampshireUniversity, hospital or other
- Collaborators
- University of Florida, Georgetown University, Hugo W. Moser Research Institute at Kennedy Krieger, Inc., Patient-Centered Outcomes Research Institute
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemental health START | Experimental | Other: Intake and quarterly assessment:, Other: Consultation & coping skills coaching:, Other: 24-hour urgent crisis response and intervention:, Other: Service linkages, referrals, outreach, & training: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. |
| In-person START | Active comparator | 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. |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intake and quarterly assessment: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. | Other | In-person START, Telemental health START |
| Consultation & coping skills coaching: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. | Other | In-person START, Telemental health START |
| 24-hour urgent crisis response and intervention: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. | Other | In-person START, Telemental health START |
| Service linkages, referrals, outreach, & training: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. | Other | In-person START, Telemental health START |
Primary outcome
Change in Family Experiences Interview Schedule (FEIS) over 1 year
Time frame: Change in FEIS scores [at 2 timepoints: enrollment, and 1 year (or discharge)]
A semi-structured interview of caregiver experiences with the mental health system
4 secondary outcomes
Change in Aberrant Behavior Checklist (ABC) at 1 year
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
Time frame: Change between enrollment to 1 year (or discharge)
Time to discharge
Time frame: continuous monitoring up to 1 year
Change in mental health stability as measured by START Plan scores at 1 year
Time frame: Change in START plan scores [at 3 timepoints: enrollment, 6 months, and 1 year (or discharge)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 33334153Kalb 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.
- Background: PubMed 33032318Holingue 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.
- Background: PubMed 30715923Kalb 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.
- Background: PubMed 27561378Kalb 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.
- Derived from this study: PubMed 37491216Kalb 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan B Beasley, PhD principal investigator
University of New Hampshire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intake and quarterly assessment:, Consultation & coping skills coaching: and 24-hour urgent crisis response and intervention: in people with Mental Health Conditions and Developmental Disability, run by University of New Hampshire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Family Experiences Interview Schedule (FEIS) over 1 year (time frame: Change in FEIS scores [at 2 timepoints: enrollment, and 1 year (or discharge)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05336955, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.