Randomized Controlled Trial of a Behavioral Training App

NCT06447909 | Recruiting

• 1 other identifier: IRB-FY2024-8463
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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; Depression; Stress

Outcome Measures

Primary Outcomes (3)

• IOWA Conners Rating Scale

  The IOWA-CRS (Waschbusch \& Willoughby, 2008) is a widely used brief measure of attention-deficit/hyperactivity disorder and oppositional-defiant behavior in children completed by parents. The IOWA-CRS consists of 10 items evaluated using a four-point Likert scale with the following anchors: not at all (0); just a little (1); pretty much (2); and very much (3).

  before starting the intervention, throughout the 8 week intervention

• The Disruptive Behavior Disorders (DBD) Rating Scale (Pelham et al., 1992)

  The DBD scale consists of 23 items from the full 45-item measure that asks parents to rate symptoms of ADHD, ODD, and CD on a 4-point Likert scale (i.e., "not at all", "just a little", "pretty much", or "very much"), with higher scores indicating more problems. For this study, the average scores for ADHD, ODD and CD will be used. Support for the scale's reliability and validity have been reported in past samples, with acceptable levels of internal consistency (.82) and concurrent correlations with other measures used for diagnosis of ADHD and ODD being reported (Pelham et al., 2005).

  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)

  The IRS is a multidimensional measure that assesses functioning across domains. Specifically, the IRS qualifies and quantifies impairment present in a child's life, both in school and non-school settings. The scale has parent and teacher versions that ask about the degree to which the child has problems that warrant treatment, intervention, or special services in specific areas of functioning. For children ages 4 through 12, the IRS has shown good psychometric properties and has empirically derived cutoff points. The IRS asks the informant to respond using a 7-point scale that ranges from "No problem; definitely does not need treatment or special services'' to "Extreme problem; definitely needs treatment or special services." The IRS exhibits concurrent, discriminant, and convergent validity, and acceptable levels of temporal stability.

  before starting the intervention, 4 weeks after starting the intervention, and 8 weeks after starting the intervention

Secondary Outcomes (3)

• Revised Child Anxiety and Depression Scale - Parent version (R-CADS-P; Chorpita & Spence, 2003)

  before starting the intervention, 4 weeks after starting the intervention, and 8 weeks after starting the intervention

• The Parenting Stress Index-Short Form (PSI-SF) (Abidin, 1995)

  before starting the intervention, 4 weeks after starting the intervention, and 8 weeks after starting the intervention

• Usability Survey

  8 weeks after starting the intervention

Study Arms (2)

Placebo app

PLACEBO COMPARATOR

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.

Behavioral: Sham app

Treatment app

EXPERIMENTAL

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.

Behavioral: Treatment App

Interventions

Treatment App 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.

Treatment app

Sham app 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.

Placebo app

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York University: lead
• Joon, Inc.: collaborator

Study Sites (1)

New York University

New York, New York, 10003, United States

RECRUITING

Related Publications (13)

• Breider S, de Bildt A, Nauta MH, Hoekstra PJ, van den Hoofdakker BJ. Self-directed or therapist-led parent training for children with attention deficit hyperactivity disorder? A randomized controlled non-inferiority pilot trial. Internet Interv. 2019 Aug 8;18:100262. doi: 10.1016/j.invent.2019.100262. eCollection 2019 Dec.

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  PMID: 30316482 BACKGROUND

• DuPaul GJ. Promoting Success Across School Years for Children With Attention-Deficit/Hyperactivity Disorder: Collaborative School-Home Intervention. J Am Acad Child Adolesc Psychiatry. 2018 Apr;57(4):231-232. doi: 10.1016/j.jaac.2018.02.001.

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• Tate DF, Finkelstein EA, Khavjou O, Gustafson A. Cost effectiveness of internet interventions: review and recommendations. Ann Behav Med. 2009 Aug;38(1):40-5. doi: 10.1007/s12160-009-9131-6.

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• Thongseiratch T, Leijten P, Melendez-Torres GJ. Online parent programs for children's behavioral problems: a meta-analytic review. Eur Child Adolesc Psychiatry. 2020 Nov;29(11):1555-1568. doi: 10.1007/s00787-020-01472-0. Epub 2020 Jan 10.

  PMID: 31925545 BACKGROUND

• Chacko A, Jensen SA, Lowry LS, Cornwell M, Chimklis A, Chan E, Lee D, Pulgarin B. Engagement in Behavioral Parent Training: Review of the Literature and Implications for Practice. Clin Child Fam Psychol Rev. 2016 Sep;19(3):204-15. doi: 10.1007/s10567-016-0205-2.

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• Barbaresi WJ, Campbell L, Diekroger EA, Froehlich TE, Liu YH, O'Malley E, Pelham WE Jr, Power TJ, Zinner SH, Chan E. Society for Developmental and Behavioral Pediatrics Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents with Complex Attention-Deficit/Hyperactivity Disorder. J Dev Behav Pediatr. 2020 Feb/Mar;41 Suppl 2S:S35-S57. doi: 10.1097/DBP.0000000000000770.

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  PMID: 15380788 BACKGROUND

MeSH Terms

Conditions

Child Behavior; Problem Behavior; Attention Deficit Disorder with Hyperactivity; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Anil Chacko, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anil Chacko, PhD

CONTACT

(212) 998-5749; ac5489@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 7, 2024
• Study Start: March 27, 2024
• Primary Completion: August 30, 2024
• Study Completion: October 30, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)