TeleABA for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorCaring Technologies, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Standard Hospital Care

    Behavioral

    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)

    Behavioral

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Standard Hospital CareActive comparator 1 intervention
Group B: Standard Hospital Care + Telehealth Applied Behavior Analysis (TeleABA)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed at baseline (hospital admission), at hospital discharge, and at 2 and 6 weeks post-discharge, assessed up to 365 days.

Secondary outcomes

1

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.

Time frame
Assessed at hospital discharge and 2 weeks post-discharge, assessed up to 365 days.
2

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.

Time frame
Assessed at baseline (hospital admission), hospital discharge, and 2 weeks post-discharge, assessed up to 365 days.
3

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.

Time frame
Day of hospital admission to day of hospital discharge, assessed up to 365 days.
4

Use of Restrictive Interventions

Number of manual or chemical restraint events during hospitalization, extracted from the electronic health record.

Time frame
Day of hospital admission to day of hospital discharge, assessed up to 365 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Caring Technologies, Inc.

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Hackensack Meridian Health

Collaborator

Center for Social Dynamics

Collaborator

Rutgers University

Collaborator

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