Autism Spectrum Disorder (ASD)NCT07701915
TeleABA for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder
A study testing Standard Hospital Care and Telehealth Applied Behavior Analysis (TeleABA) in people with Autism Spectrum Disorder (ASD), run by Caring Technologies, Inc. at 2 sites in United States.
Trial summary
This study is evaluating whether a telehealth-based applied behavior analysis (ABA) program can improve the care of adolescents and young adults with autism spectrum disorder (ASD) who are hospitalized because of severe challenging behaviors, such as aggression, self-injury, property destruction, or elopement. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- Standard Hospital Care and Telehealth Applied Behavior Analysis (TeleABA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2026to 31 Jul 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 years or older.
- Established or documented diagnosis of autism spectrum disorder (ASD) in the electronic medical record or confirmed by the attending provider using DSM-5 criteria.
- Admitted to a participating Hackensack Meridian Health hospital due to behavioral concerns (e.g., aggression, self-injury, elopement, or property destruction) that contribute to or prolong hospitalization.
- Behavioral support identified by the attending provider as a primary component of the current admission.
- Caregiver or legally authorized representative (LAR) able to provide informed consent.
- Patient assent obtained when applicable.
- Voluntary, court-mandated, and ward-of-the-state admissions are eligible.
Who cannot join
- Admission for an acute medical condition in which behavioral concerns are not a primary driver of hospitalization.
- Medical instability that precludes participation in telehealth sessions.
- Absence of a caregiver or legally authorized representative able to provide informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Hackensack Meridian Health Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Christopher DeBari, 732-776-3198, christopher.debari@hmhn.org
Tom Priolo, M.D.
Children's Specialized Hospital-Rutgers University Center for Autism Research, Education, and Services (CSH-RUCARES)
Somerset, New Jersey, 08873
About this study
Official title: Transforming Hospitalizations of Autistic Adolescents Via a Novel ABA Telehealth Platform
This study is evaluating whether a telehealth-based applied behavior analysis (ABA) program can improve the care of adolescents and young adults with autism spectrum disorder (ASD) who are hospitalized because of severe challenging behaviors, such as aggression, self-injury, property destruction, or elopement.
Participants will be randomly assigned to receive either standard hospital care alone or standard hospital care plus a Telehealth Applied Behavior Analysis for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder (TeleABA) program. The TeleABA program includes assessment by a Board Certified Behavior Analyst (BCBA), individualized behavior support recommendations, coaching for hospital staff, caregiver training, discharge planning, and four weekly telehealth sessions with caregivers after the participant leaves the hospital.
Researchers will compare the two groups to determine whether the TeleABA program improves behavioral outcomes, caregiver confidence and stress, hospital experiences, and the transition from the hospital to home. The findings may help identify more effective ways to support individuals with autism and their families during and after behavioral health hospitalizations.
Read the detailed description
Adolescents and young adults with autism spectrum disorder (ASD) who require psychiatric hospitalization because of severe challenging behaviors often have complex behavioral support needs that may not be fully addressed through standard inpatient care alone. Behavioral crises during hospitalization can contribute to prolonged length of stay, increased use of restrictive interventions, caregiver distress, and challenges during the transition from hospital to home.
This randomized controlled trial will evaluate whether adding a Telehealth Applied Behavior Analysis (TeleABA) intervention to standard inpatient behavioral health care improves clinical, caregiver, and hospital outcomes compared with standard hospital care alone.
Participants will be randomly assigned in a 1:1 ratio to receive either standard hospital care or standard hospital care plus TeleABA. Standard hospital care includes routine inpatient behavioral health services provided by the treating hospital, including psychiatric evaluation, medication management, nursing care, therapeutic programming, and discharge planning.
The TeleABA intervention is delivered by a Board Certified Behavior Analyst (BCBA) and includes caregiver interviews, behavioral assessment, functional assessment when indicated, individualized behavior support recommendations, consultation and coaching for hospital staff, caregiver training, discharge planning, and four weekly telehealth caregiver coaching sessions following hospital discharge to support implementation of behavior support strategies and continuity of care.
The primary outcome is change in irritability measured using the Aberrant Behavior Checklist-Irritability (ABC-I). Secondary outcomes include clinician-rated improvement and severity, hospital length of stay, use of restrictive interventions, caregiver transition outcomes, and family perceptions of care. Assessments will be conducted during hospitalization and through 6 weeks after hospital discharge.
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- Standard Hospital Care, Telehealth Applied Behavior Analysis (TeleABA)
- Keywords
- Autism Spectrum Disorder, Applied Behavior Analysis (ABA), Telehealth, Caregiver Training, Challenging Behavior, Crisis Prevention, Behavioral Crisis, Hospitalization
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Hospital CareBehavioural
Standard inpatient behavioral health care provided by the hospital, including psychiatric evaluation, medication management, nursing care, therapeutic programming, and discharge planning in accordance with routine clinical practice.
Telehealth Applied Behavior Analysis (TeleABA)Behavioural
The TeleABA intervention is a telehealth-delivered applied behavior analysis (ABA) program designed to support adolescents and young adults with autism spectrum disorder during hospitalization and the transition to home. A Board Certified Behavior Analyst (BCBA) conducts caregiver interviews, behavioral assessment, functional assessment when indicated, and develops individualized behavior support recommendations. The intervention includes consultation and coaching for hospital staff, caregiver training, discharge planning, and four weekly telehealth caregiver coaching sessions following hospital discharge to support implementation of behavior support strategies and continuity of care.
| Study group | Role | What they receive |
|---|---|---|
| Standard Hospital Care | Active comparator | Participants will receive standard inpatient behavioral health care provided by the hospital, including psychiatric evaluation, medication management, nursing care, therapeutic programming, and discharge planning. Participants in this arm will not receive the TeleABA intervention. Receives: Behavioral: Standard Hospital Care |
| Standard Hospital Care + Telehealth Applied Behavior Analysis (TeleABA) | Experimental | Participants will receive standard inpatient behavioral health care plus the TeleABA intervention. The TeleABA intervention includes behavioral assessment, individualized behavior support recommendations, coaching for hospital staff, caregiver training, discharge planning, and four weekly telehealth caregiver coaching sessions following hospital discharge. Receives: Behavioral: Telehealth Applied Behavior Analysis (TeleABA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aberrant Behavior Checklist-Irritability (ABC-I) Score
The Aberrant Behavior Checklist-Irritability Subscale is a caregiver-reported measure of irritability, agitation, aggression, tantrums, and self-injurious behavior. Scores range from 0 to 45, with higher scores indicating greater irritability and more severe behavioral symptoms. The primary outcome is the change from baseline in ABC-I score, comparing participants receiving Hospital TeleABA with those receiving standard care.
Measured: Assessed at baseline (hospital admission), at hospital discharge, and at 2 and 6 weeks post-discharge, assessed up to 365 days.
Secondary outcomes (6)
Clinical Global Impression-Improvement (CGI-I)
The Clinical Global Impression-Improvement (CGI-I) is a clinician-rated measure of overall improvement in behavioral symptoms compared with baseline. Scores range from 1 to 7, where 1 = very much improved, 4 = no change, and 7 = very much worse. Lower scores indicate greater clinical improvement. CGI-I scores will be compared between participants receiving Hospital TeleABA and standard care.
Measured: Assessed at hospital discharge and 2 weeks post-discharge, assessed up to 365 days.
Clinical Global Impression-Severity (CGI-S)
The Clinical Global Impression-Severity (CGI-S) is a clinician-rated measure of the severity of behavioral symptoms at the time of assessment. Scores range from 1 to 7, where 1 = normal, not at all ill and 7 = among the most extremely ill patients. Higher scores indicate greater symptom severity. CGI-S scores will be compared between participants receiving Hospital TeleABA and standard care.
Measured: Assessed at baseline (hospital admission), hospital discharge, and 2 weeks post-discharge, assessed up to 365 days.
Hospital Length of Stay, days
Hospital length of stay, defined as the number of days from hospital admission to hospital discharge, obtained from the electronic health record.
Measured: Day of hospital admission to day of hospital discharge, assessed up to 365 days.
Use of Restrictive Interventions
Number of manual or chemical restraint events during hospitalization, extracted from the electronic health record.
Measured: Day of hospital admission to day of hospital discharge, assessed up to 365 days.
Caregiver Transition Survey
The Caregiver Transition Survey is a caregiver-reported questionnaire assessing caregiver distress, confidence managing behavioral and safety needs, confidence implementing discharge recommendations, and crisis readiness. Each item is rated on a 6-point ordinal scale ranging from 0 (Not at all) to 5 (Extremely). Individual item ratings will be compared between groups.
Measured: Assessed at baseline (hospital admission), hospital discharge, 2 weeks post-discharge, and 6 weeks post-discharge. Assessed up to 365 days.
Family Perception of Care Survey Item Ratings
The Family Perception of Care Survey includes caregiver-reported ordinal item ratings of perceived benefit of behavioral consultation, perceived reduction in support needs, perceived safety, and readiness to return home. Individual ordinal survey item ratings will be compared between groups.
Measured: Assessed at hospital discharge, 2 weeks post-discharge, and 6 weeks post-discharge. Assessed up to 365 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caring Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Hackensack Meridian Health, Center for Social Dynamics, Rutgers University
- Responsible party
- Sponsor
- Investigators
- Ron Oberleitner, Principal investigator, Caring Technologies, Inc.Joy Pollard, Ph.D., Principal investigator, Center for Social Dynamics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701915
- Sponsor's protocol ID
- TeleABA-WCG-20253445
- Other IDs
- 5R44MH134706-03
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Hospitalizations of Autistic Adolescents Via a Novel ABA Telehealth Platform
- ClinicalTrials.gov ID
- NCT07701915
- Acronym / sponsor ID
- TeleABA-WCG-20253445
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- Autism Spectrum Disorder, Applied Behavior Analysis (ABA), Telehealth, Caregiver Training, Challenging Behavior, Crisis Prevention, Behavioral Crisis, Hospitalization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Caring Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Hackensack Meridian Health, Center for Social Dynamics, Rutgers University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 14 Jul 2026 (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.
This study is evaluating whether a telehealth-based applied behavior analysis (ABA) program can improve the care of adolescents and young adults with autism spectrum disorder (ASD) who are hospitalized because of severe challenging behaviors, such as aggression, self-injury, property destruction, or elopement.
Participants will be randomly assigned to receive either standard hospital care alone or standard hospital care plus a Telehealth Applied Behavior Analysis for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder (TeleABA) program. The TeleABA program includes assessment by a Board Certified Behavior Analyst (BCBA), individualized behavior support recommendations, coaching for hospital staff, caregiver training, discharge planning, and four weekly telehealth sessions with caregivers after the participant leaves the hospital.
Researchers will compare the two groups to determine whether the TeleABA program improves behavioral outcomes, caregiver confidence and stress, hospital experiences, and the transition from the hospital to home. The findings may help identify more effective ways to support individuals with autism and their families during and after behavioral health hospitalizations.
Detailed description
Adolescents and young adults with autism spectrum disorder (ASD) who require psychiatric hospitalization because of severe challenging behaviors often have complex behavioral support needs that may not be fully addressed through standard inpatient care alone. Behavioral crises during hospitalization can contribute to prolonged length of stay, increased use of restrictive interventions, caregiver distress, and challenges during the transition from hospital to home.
This randomized controlled trial will evaluate whether adding a Telehealth Applied Behavior Analysis (TeleABA) intervention to standard inpatient behavioral health care improves clinical, caregiver, and hospital outcomes compared with standard hospital care alone.
Participants will be randomly assigned in a 1:1 ratio to receive either standard hospital care or standard hospital care plus TeleABA. Standard hospital care includes routine inpatient behavioral health services provided by the treating hospital, including psychiatric evaluation, medication management, nursing care, therapeutic programming, and discharge planning.
The TeleABA intervention is delivered by a Board Certified Behavior Analyst (BCBA) and includes caregiver interviews, behavioral assessment, functional assessment when indicated, individualized behavior support recommendations, consultation and coaching for hospital staff, caregiver training, discharge planning, and four weekly telehealth caregiver coaching sessions following hospital discharge to support implementation of behavior support strategies and continuity of care.
The primary outcome is change in irritability measured using the Aberrant Behavior Checklist-Irritability (ABC-I). Secondary outcomes include clinician-rated improvement and severity, hospital length of stay, use of restrictive interventions, caregiver transition outcomes, and family perceptions of care. Assessments will be conducted during hospitalization and through 6 weeks after hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Hospital Care | Active comparator | Behavioral: Standard Hospital CareParticipants will receive standard inpatient behavioral health care provided by the hospital, including psychiatric evaluation, medication management, nursing care, therapeutic programming, and discharge planning. Participants in this arm will not receive the TeleABA intervention. |
| Standard Hospital Care + Telehealth Applied Behavior Analysis (TeleABA) | Experimental | Behavioral: Telehealth Applied Behavior Analysis (TeleABA)Participants will receive standard inpatient behavioral health care plus the TeleABA intervention. The TeleABA intervention includes behavioral assessment, individualized behavior support recommendations, coaching for hospital staff, caregiver training, discharge planning, and four weekly telehealth caregiver coaching sessions following hospital discharge. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age 12 years or older.
- Established or documented diagnosis of autism spectrum disorder (ASD) in the electronic medical record or confirmed by the attending provider using DSM-5 criteria.
- Admitted to a participating Hackensack Meridian Health hospital due to behavioral concerns (e.g., aggression, self-injury, elopement, or property destruction) that contribute to or prolong hospitalization.
- Behavioral support identified by the attending provider as a primary component of the current admission.
- Caregiver or legally authorized representative (LAR) able to provide informed consent.
Key exclusion criteria (3 listed)
- Admission for an acute medical condition in which behavioral concerns are not a primary driver of hospitalization.
- Medical instability that precludes participation in telehealth sessions.
- Absence of a caregiver or legally authorized representative able to provide informed consent.
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 |
|---|---|---|
| Standard Hospital CareStandard inpatient behavioral health care provided by the hospital, including psychiatric evaluation, medication management, nursing care, therapeutic programming, and discharge planning in accordance with routine clinical practice. | Behavioural | Standard Hospital Care |
| Telehealth Applied Behavior Analysis (TeleABA)The TeleABA intervention is a telehealth-delivered applied behavior analysis (ABA) program designed to support adolescents and young adults with autism spectrum disorder during hospitalization and the transition to home. A Board Certified Behavior Analyst (BCBA) conducts caregiver interviews, behavioral assessment, functional assessment when indicated, and develops individualized behavior support recommendations. The intervention includes consultation and coaching for hospital staff, caregiver training, discharge planning, and four weekly telehealth caregiver coaching sessions following hospital discharge to support implementation of behavior support strategies and continuity of care. | Behavioural | Standard Hospital Care + Telehealth Applied Behavior Analysis (TeleABA) |
Primary outcome
Change in Aberrant Behavior Checklist-Irritability (ABC-I) Score
Time frame: Assessed at baseline (hospital admission), at hospital discharge, and at 2 and 6 weeks post-discharge, assessed up to 365 days.
The Aberrant Behavior Checklist-Irritability Subscale is a caregiver-reported measure of irritability, agitation, aggression, tantrums, and self-injurious behavior. Scores range from 0 to 45, with higher scores indicating greater irritability and more severe behavioral symptoms. The primary outcome is the change from baseline in ABC-I score, comparing participants receiving Hospital TeleABA with those receiving standard care.
6 secondary outcomes
Clinical Global Impression-Improvement (CGI-I)
Time frame: Assessed at hospital discharge and 2 weeks post-discharge, assessed up to 365 days.
Clinical Global Impression-Severity (CGI-S)
Time frame: Assessed at baseline (hospital admission), hospital discharge, and 2 weeks post-discharge, assessed up to 365 days.
Hospital Length of Stay, days
Time frame: Day of hospital admission to day of hospital discharge, assessed up to 365 days.
Use of Restrictive Interventions
Time frame: Day of hospital admission to day of hospital discharge, assessed up to 365 days.
Caregiver Transition Survey
Time frame: Assessed at baseline (hospital admission), hospital discharge, 2 weeks post-discharge, and 6 weeks post-discharge. Assessed up to 365 days.
Family Perception of Care Survey Item Ratings
Time frame: Assessed at hospital discharge, 2 weeks post-discharge, and 6 weeks post-discharge. Assessed up to 365 days.
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 14 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Hackensack Meridian Health Jersey Shore University Medical Center
Neptune City, United States
Ron Oberleitner principal investigator
Caring Technologies, Inc.
Joy Pollard, Ph.D. principal investigator
Center for Social Dynamics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Hospital Care and Telehealth Applied Behavior Analysis (TeleABA) in people with Autism Spectrum Disorder (ASD), run by Caring Technologies, Inc. at 2 sites 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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aberrant Behavior Checklist-Irritability (ABC-I) Score (time frame: Assessed at baseline (hospital admission), at hospital discharge, and at 2 and 6 weeks post-discharge, assessed up to 365 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.