Randomized Controlled Trial of a Behavioral Training App

NCT ID: NCT06447909

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-27
• Study Completion Date: 2024-10-30

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo app

Behavioral interventions are a well-established psychosocial intervention for the treatment of disruptive behavior disorders and related behavioral difficulties (e.g., ODD, ADHD). Behavioral training is based on social learning and operant conditioning principles in which parents are instructed to utilize positive reinforcement and reward systems to facilitate positive behaviors (e.g., compliance) in their child and reduce challenging behaviors (e.g., opposition). The intervention involves the use of an app to deliver a behavioral intervention using contingency reward systems. It translates established content and processes into a digital format to be delivered through a mobile app. For both conditions, there will be a parent and a child version of the app which are linked. The placebo arm will receive access to an app that does not include the contingency reward system.

Group Type: PLACEBO_COMPARATOR

Sham app

Intervention Type: BEHAVIORAL

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.

Treatment app

Behavioral interventions are a well-established psychosocial intervention for the treatment of disruptive behavior disorders and related behavioral difficulties (e.g., ODD, ADHD). Behavioral training is based on social learning and operant conditioning principles in which parents are instructed to utilize positive reinforcement and reward systems to facilitate positive behaviors (e.g., compliance) in their child and reduce challenging behaviors (e.g., opposition). The intervention involves the use of an app to deliver a behavioral intervention using contingency reward systems. It translates established content and processes into a digital format to be delivered through a mobile app. For both conditions, there will be a parent and a child version of the app which are linked. The treatment app involves the use of contingency reward systems to shape targeted behaviors in children. The treatment app also includes psychoeducational guides for parents to review daily.

Group Type: EXPERIMENTAL

Treatment App

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• the child must be between the ages of 6-12 at the time of baseline/pre-intervention data collection
• the child must have an elevated score based on the strengths and Difficulties Questionnaire (SDQ)
• the parent/caregiver must be a fluent English speaker
• the parent/caregiver must be the legal guardians of and have full-time custody/child care responsibilities for their child (parents/caregiver with limited contact with their child will not have the opportunity to sufficiently use the app with their child)
• the parent/caregiver must have reliable and stable mobile internet access
• the parent/caregiver must use an Apple iOS operating system (the research version of the app will only be available in iOS) on their phone
• the parent/caregiver and their child must reside in the United States.

Exclusion Criteria

• the child or parent/caregiver presents with emergency psychiatric needs that require services beyond those that can be managed within this intervention format (e.g., hospitalization, specialized placement outside the home); In this case, an active intervention by research staff to secure what is needed will be made
• if the child has an elevated score for Autism Spectrum Disorder (ASD) on the Developmental Behavior Checklist-Autism Screening Algorithm and the parent indicates that their child was diagnosed with autism or another pervasive developmental disorder;
• if the parent/caregiver is currently enrolled or has recently enrolled in any type of behavioral therapy program (i.e., within the past six months)
• the caregiver has used the Joon app in the past. If the child is currently taking medication, families that participate in the study will be asked to keep their child's medication status stable and report changes immediately to the project director.
• Additionally, participants may be removed from the study if their child's symptoms worsen considerably such that the child requires more immediate professional intervention.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joon, Inc.

UNKNOWN

Sponsor Role: collaborator

New York University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anil Chacko, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

New York University

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anil Chacko, PhD

Role: CONTACT

ac5489@nyu.edu

(212) 998-5749

Facility Contacts

Anil Chacko, PhD

Role: primary

ac5489@nyu.edu

212-998-5749

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Other Identifiers

IRB-FY2024-8463

Identifier Type: -

Identifier Source: org_study_id