Recruiting

Behavioral Training App

Sponsor:

New York University

Code:

NCT06447909

Conditions

Behavior, Child

Disruptive Behavior

Executive Dysfunction

Attention-deficit

Anxiety

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

Interventions

Treatment App

Sham app

Study Details

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.

Conditions

Behavior, Child

Disruptive Behavior

Executive Dysfunction

Attention-deficit

Anxiety

Study ID

NCT06447909

Start date

Mar 27, 2024

Status verified date

Apr, 2024

Completion date

Oct 30, 2024

Anticipated

Primary completion date

Aug 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: 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.

experimental: 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.

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.

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.

Primary outcome measure

  • IOWA Conners Rating Scale [ Time Frame: before starting the intervention, throughout the 8 week intervention ]
  • The Disruptive Behavior Disorders (DBD) Rating Scale (Pelham et al., 1992) [ Time Frame: before starting the intervention, 4 weeks after starting the intervention, and 8 weeks after starting the intervention ]
  • Impairment Rating Scale - Parent/Teacher Version (IRS) (Pelham, Fabiano, & Massetti, 2005) [ Time Frame: before starting the intervention, 4 weeks after starting the intervention, and 8 weeks after starting the intervention ]

Central Contacts and Locations

Central contacts

Anil Chacko, PhD

(212) 998-5749ac5489@nyu.edu

Locations

New York University

Recruiting

New York, New York, United States, 10003

Contacts

Anil Chacko, PhD

212-998-5749ac5489@nyu.edu

More Information

Sponsor

New York University

Last update posted

Jun 7, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2024-06-07.