跳至主要内容
临床试验/NCT07042347
NCT07042347招募中不适用

RCT of a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Strengths and Difficulties Questionnaire total score

研究概览

简要总结

The goal of this clinical trial is to test whether a smartphone-based data collection and feedback application ("Footsteps") improves the quality of behavioral data collected by one-to-one aides and leads to better youth mental health outcomes in school-aged youth (ages 4-17) who receive one-to-one support in schools.

The main questions it aims to answer are:

  1. Does the Footsteps app improve aides' data collection quality (i.e., consistency, timeliness, and completeness)?
  2. Does Footsteps use lead to improved youth behavioral health outcomes (e.g., SDQ, YTP scores)?
  3. Does Footsteps improve communication and supervision processes between aides and clinical supervisors?

Researchers will compare aides using Footsteps to those using a "data collection only" control app to see if Footsteps leads to higher quality data collection, enhanced supervisory communication, and better youth outcomes.

Participants will:

  • Use either Footsteps or a control app to record de-identified data on one client's behaviors and skills over 12 weeks
  • Complete biweekly online surveys about data collection experiences, youth progress, and aide-supervisor communication
  • Participate in a virtual intake and post-trial meeting
  • (For a subset) Participate in a 30-45 minute qualitative interview about their experience using the app

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aides must be working with at least one client in school who meets the following criteria: 1) between 3-17 years, 2) has a diagnosis associated with a challenging behavior (e.g., autism spectrum disorder, attention deficit hyperactivity disorder, oppositional defiant disorder) as indicated on their treatment plan, and 3) receiving 1:1 aide support.
  • Supervisors must be employed by a community behavior health agency and supervise a participating aide. The investigators will recruit supervisors in dyads and not triads (i.e., no supervisors with two [or more] aides) to ensure there are 30 supervisor-aide dyads in total).

排除标准

  • Aides who participated in the pilot trial of the Footsteps will be excluded from participating to recruit a sample naïve to Footsteps and the control app.

研究组 & 干预措施

Footsteps (Enhancements)

Experimental

An electronic platform for data collection ("Footsteps") that contains additional features designed to increase motivation to collect data and ease of data collection.

干预措施: Behavioral economics strategies (Behavioral)

Footsteps (Enhancements)

Experimental

An electronic platform for data collection ("Footsteps") that contains additional features designed to increase motivation to collect data and ease of data collection.

干预措施: Electronic platform (Device)

Data Collection Only App (No Enhancements)

Active Comparator

A basic electronic platform for data collection.

干预措施: Electronic platform (Device)

结局指标

主要结局

Strengths and Difficulties Questionnaire total score

时间窗: Assessed monthly (Baseline; Weeks 4, 8, and 12)

A behavioral screening tool used to assess psychological attributes in children and adolescents, leading to a total score of 0 to 40. A higher total score indicates greater difficulties in emotional and behavioral functioning, while lower scores suggest fewer difficulties.

Data collection consistency

时间窗: Assessed throughout 12-week trial

an aggregate of the numbers of intervals scheduled, and the numbers of those intervals in which data was entered (% real time data)

Data collection timeliness

时间窗: Assessed throughout 12-week trial

for intervals in which data was entered, the time lag between occurrence and data entry

次要结局

  • Goal Attainment Scaling(Assessed biweekly, at baseline through 12-week trial)
  • Data collection completeness(Assessed throughout 12-week trial)
  • Youth Top Problems(Assessed biweekly, at baseline through 12-week trial)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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