Randomized Controlled Trial of a Behavioral Training App

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.

Conditions

• Behavior, Child
• Disruptive Behavior
• Executive Dysfunction
• Attention-deficit
• Anxiety
• Depression
• Stress

Interventions

BEHAVIORAL

Treatment App

The behavioral treatment app content consists of tasks that caregivers can assign to their children in the app (e.g., finish homework, make bed, etc.). These tasks are completed offline, and then caregivers "approve" the child's completion of those tasks through the app, administering a token reward (coins) in-app. In the child version of the app, children take care of a virtual pet by feeding, cleaning, buying various accessories (using in-game coins), and exploring different lands with the virtual pet. The caregiver-assigned token coins can be used to redeem items needed to raise their pet, and access virtual lands. Caregivers can also choose to have their child redeem virtual tokens for real-life rewards. Ultimately, the app combines a video game with evidence-based principles to help children practice important tasks and behaviors as administered by caregivers.

BEHAVIORAL

Sham app

As described above, the child will access a virtual pet that they can feed, clean and buy various accessories by redeeming virtual coins. They will not be able to explore different lands with that pet. Coins in the placebo version will be rewarded non-contingently. Additionally, children will not be able to redeem coins for real-life rewards as above in the treatment app. Caregivers will not need to review and approve tasks in order to redeem coins. The caregiver-version of the app will not contain the Assigned or Review tabs as assigned above, since the child will earn coins regardless of whether or not they complete tasks, so caregivers will not be able to review nor assign tasks. Instead, caregivers in this group will only have access to the guide tab which will contain helpful articles the parent can read about disruptive behavior problems in children.

Sponsors & Collaborators

• Joon, Inc.

  collaborator UNKNOWN

• New York University

  lead OTHER

Principal Investigators

• Anil Chacko, PhD · New York University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-27

Primary Completion

2024-08-30

Completion

2024-10-30

Countries

• United States

Study Locations