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临床试验/NCT07701915
NCT07701915尚未招募不适用

Transforming Hospitalizations of Autistic Adolescents Via a Novel ABA Telehealth Platform

Caring Technologies, Inc.2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
2
主要终点
Change in Aberrant Behavior Checklist-Irritability (ABC-I) Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Standard Hospital Care (Behavioral)

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.

干预措施: Telehealth Applied Behavior Analysis (TeleABA) (Behavioral)

结局指标

主要结局

Change in Aberrant Behavior Checklist-Irritability (ABC-I) Score

时间窗: 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.

次要结局

  • Clinical Global Impression-Improvement (CGI-I)(Assessed at hospital discharge and 2 weeks post-discharge, assessed up to 365 days.)
  • Clinical Global Impression-Severity (CGI-S)(Assessed at baseline (hospital admission), hospital discharge, and 2 weeks post-discharge, assessed up to 365 days.)
  • Hospital Length of Stay, days(Day of hospital admission to day of hospital discharge, assessed up to 365 days.)
  • Use of Restrictive Interventions(Day of hospital admission to day of hospital discharge, assessed up to 365 days.)
  • Caregiver Transition Survey(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(Assessed at hospital discharge, 2 weeks post-discharge, and 6 weeks post-discharge. Assessed up to 365 days.)

研究者

发起方
Caring Technologies, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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