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TeleABA for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder

13 luglio 2026 aggiornato da: Caring Technologies, Inc.

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • New Jersey
      • Neptune City, New Jersey, Stati Uniti, 07753
        • Hackensack Meridian Health Jersey Shore University Medical Center
        • Contatto:
        • Investigatore principale:
          • Tom Priolo, M.D.
      • Somerset, New Jersey, Stati Uniti, 08873
        • Children's Specialized Hospital-Rutgers University Center for Autism Research, Education, and Services (CSH-RUCARES)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Standard Hospital Care
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.
Comportamentale: Standard Hospital Care
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.
Sperimentale: Standard Hospital Care + 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Aberrant Behavior Checklist-Irritability (ABC-I) Score
Lasso di tempo: 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.
Assessed at baseline (hospital admission), at hospital discharge, and at 2 and 6 weeks post-discharge, assessed up to 365 days.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Clinical Global Impression-Improvement (CGI-I)
Lasso di tempo: Assessed at hospital discharge and 2 weeks post-discharge, assessed up to 365 days.
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.
Assessed at hospital discharge and 2 weeks post-discharge, assessed up to 365 days.
Clinical Global Impression-Severity (CGI-S)
Lasso di tempo: Assessed at baseline (hospital admission), hospital discharge, and 2 weeks post-discharge, assessed up to 365 days.
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.
Assessed at baseline (hospital admission), hospital discharge, and 2 weeks post-discharge, assessed up to 365 days.
Hospital Length of Stay, days
Lasso di tempo: Day of hospital admission to day of hospital discharge, assessed up to 365 days.
Hospital length of stay, defined as the number of days from hospital admission to hospital discharge, obtained from the electronic health record.
Day of hospital admission to day of hospital discharge, assessed up to 365 days.
Use of Restrictive Interventions
Lasso di tempo: Day of hospital admission to day of hospital discharge, assessed up to 365 days.
Number of manual or chemical restraint events during hospitalization, extracted from the electronic health record.
Day of hospital admission to day of hospital discharge, assessed up to 365 days.
Caregiver Transition Survey
Lasso di tempo: Assessed at baseline (hospital admission), hospital discharge, 2 weeks post-discharge, and 6 weeks post-discharge. Assessed up to 365 days.
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.
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
Lasso di tempo: Assessed at hospital discharge, 2 weeks post-discharge, and 6 weeks post-discharge. Assessed up to 365 days.
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.
Assessed at hospital discharge, 2 weeks post-discharge, and 6 weeks post-discharge. Assessed up to 365 days.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Caring Technologies, Inc.

Collaboratori

National Institute of Mental Health (NIMH)
Hackensack Meridian Health
Rutgers University
Center for Social Dynamics

Investigatori

  • Investigatore principale: Ron Oberleitner, Caring Technologies, Inc.
  • Investigatore principale: Joy Pollard, Ph.D., Center for Social Dynamics

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

31 luglio 2027

Date di iscrizione allo studio

Primo inviato

29 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 luglio 2026

Primo Inserito (Effettivo)

14 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TeleABA-WCG-20253445
  • 5R44MH134706-03 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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