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TeleABA for Hospitalized Adolescents and Young Adults With Autism Spectrum Disorder

13. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

120

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 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.
Verhalten: 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.
Experimental: 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Aberrant Behavior Checklist-Irritability (ABC-I) Score
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical Global Impression-Improvement (CGI-I)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Caring Technologies, Inc.

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

30. Juni 2027

Studienabschluss (Geschätzt)

31. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

29. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juli 2026

Zuerst gepostet (Tatsächlich)

14. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TeleABA-WCG-20253445
  • 5R44MH134706-03 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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