Randomized Controlled Trial of a Behavioral Training App

Depression Clinical Trial

Official title: Randomized Controlled Trial of a Behavioral Training App

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Over the past several decades, much of the literature on treating both children with elevated levels of behavioral challenges as well as those children with clinical disorders such as attention-deficit/hyperactivity disorder (ADHD) and other disruptive behavior disorders (DBDs; i.e., conduct disorder (CD) and oppositional defiant disorder/ODD) has focused on evaluating the effectiveness of different treatment approaches. Behavioral interventions have been recommended as first-line psychosocial interventions for children with these challenges. Despite this recommendation, implementing behavioral interventions is often difficult for parents as there needs to be ongoing monitoring and support to refine this intervention to meet the needs of children. Reward systems are one prime example. Implementing a reward system for children facing behavioral challenges can yield numerous benefits. Firstly, it provides a positive reinforcement mechanism, encouraging desirable behavior by associating it with tangible rewards. This not only motivates children but also helps them develop a sense of accomplishment and self-control. A well-designed reward system can also enhance communication and understanding between parents, teachers, and the child, as clear expectations are established and acknowledged. Additionally, it fosters a supportive and nurturing environment, promoting a sense of trust and confidence in the child. Over time, the consistent application of a reward system can contribute to the development of long-term behavioral improvements and the acquisition of essential life skills, ultimately empowering the child to navigate challenges more effectively. However, parents often find it difficult to start and maintain a reward system.

Compounding these challenges, systemic issues such as costs of mental health services, policy, and legal restraints, limited numbers, and availability of mental health providers, regulatory restrictions, mental health stigma, and cultural and ethnic attitudes/beliefs affect access to adequate mental health services. Logistical barriers include insufficient time, lack of transportation and child care, conflicting commitments, and extensive agency waiting lists. Furthermore, there is an anticipated net decrease in mental health care professionals over the next ten years. It is of great concern that the children most at risk for untoward outcomes - those from lower socioeconomic strata - are significantly less likely to receive evidence-based treatments - particularly non-pharmacological evidence-based behavioral interventions. Both logistical and perceptual barriers pose significant barriers to service utilization and access to psychotherapy. Collectively, the limited availability of and challenges in accessing therapy are notable and impose significant limitations to the potential benefit of behavioral interventions for treating common childhood behavioral problems and clinical disorders.

Technology-based approaches to delivering evidence-based interventions have the potential to revolutionize mental health service access and delivery across multiple mental health disorders. Online (web-based and/or mobile applications) self-directed behavioral interventions are potentially more feasible, affordable, and acceptable, can have significant reach to include traditionally underserved populations, and are readily scalable and sustainable. Over 13 studies have recently been conducted demonstrating that online (web-based and mobile application) behavioral interventions can improve child behavioral outcomes.

In light of these findings, our research team has collaborated with Joon, Inc (a leading technology-based company) to test their technology-based solution to an effective, evidence-based behavioral intervention, namely, a reward system. This program evaluation aims to evaluate the already developed and commercially available Joon reward system app for its effectiveness relative to a placebo app in improving child behavioral and academic problems, impairment, and parent mental health. The evaluation will also collect feedback on participant's experience using the app.

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 treatment app compared to a placebo app control group. Participants will be randomly assigned to immediate intervention using the treatment app 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. Researchers will contact the parents via phone call to provide a 5 to 10-minute support call only if the parents do not log into the app over the course of a week (Monday through Friday). Additional support may be provided to participants based on parent requests via the study email. 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. ;

Related Conditions & MeSH terms

• Anxiety
• Behavior, Child
• Depression
• Disruptive Behavior
• Executive Dysfunction
• Problem Behavior
• Stress

• NCT number: NCT06447909
• Study type: Interventional
• Source: New York University
• Contact: Anil Chacko, PhD
• Phone: (212) 998-5749
• Email: ac5489@nyu.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2024
• Completion date: October 30, 2024