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Randomized Controlled Trial of a Behavioral Training App

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Contents

clinicaltrials.gov/study/NCT06447909
Is a
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Clinical study
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Clinical Study attributes

NCT Number
NCT064479090
Health Conditions in Trial
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Stress
0
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Anxiety
0
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Depression
0
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Executive dysfunction
0
Trial Recruitment Size
1000
Trial Sponsor
New York University
New York University
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Clinical Trial Start Date
March 27, 2024
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Primary Completion Date
August 30, 2024
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Study Completion Date
October 30, 2024
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Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Behavioral0
Interventional Trial Phase
Not Applicable0
Participating Facility
New York University
New York University
0
Official Name
Randomized Controlled Trial of a Behavioral Training App0
Last Updated
June 7, 2024
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Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Single0
Masked Party
Participant0

Other attributes

Intervention Treatment
Sham app0
Treatment App0
Study summary

The investigators propose addressing and evaluating the efficacy of a behavioral, contingency management app by conducting a randomized controlled trial (RCT) that will evaluate the app compared to a placebo app control group. Participants will be randomly assigned to immediate intervention using the treatment condition or to a placebo app condition. Participants will not know which condition they are assigned to until after the study completion; they will also not know that they are using the treatment app until after the study completion. The sample will consist of 100 families of school-age children (ages 6-12) who display significant behavioral problems. The treatment app is a task management platform containing a self-directed rewards system through which caregivers can assign token rewards to their children for completing routine tasks (e.g., cleaning their room, completing homework). Participants in the placebo app condition will have a similar user experience, however, tokens are assigned non-contingently (dispensed daily, rather than based on task completion). While participants will not be required to complete any tasks or behaviors in the app as part of their participation in the study, they will be asked to use the app at least once per day for 8 weeks. Given the self-directed nature of the treatment app (parents decide how frequently they access the app-based rewards system and how many tasks they assign to their child), parent involvement in the intervention will vary slightly in duration. However, based on the literature and routine practice, we anticipate parents will log in at least once a day to assign tasks to their child and follow up on completed rewards. Assessments (see details below) will occur at baseline, weekly during the intervention, and at the end of the study. The study will take about 8 weeks in total to complete once participants have been enrolled in the app.

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