Clinical trial NCT06447909: Randomized Controlled Trial of a Behavioral Training App
Official title: Randomized Controlled Trial of a Behavioral Training App
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavior, Child
Disruptive Behavior
Executive Dysfunction
Attention-deficit
Anxiety
Depression
Stress
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Joon, Inc.
First posted: 2024-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: IOWA Conners Rating Scale
timeFrame: before starting the intervention, throughout the 8 week intervention
measure: The Disruptive Behavior Disorders (DBD) Rating Scale (Pelham et al., 1992)
timeFrame: before starting the intervention, 4 weeks after starting the intervention, and 8 weeks after starting the intervention
measure: Impairment Rating Scale - Parent/Teacher Version (IRS) (Pelham, Fabiano, & Massetti, 2005)
timeFrame: before starting the intervention, 4 weeks after starting the intervention, and 8 weeks after starting the intervention
Secondary outcomes:
measure: Revised Child Anxiety and Depression Scale - Parent version (R-CADS-P; Chorpita & Spence, 2003)
timeFrame: before starting the intervention, 4 weeks after starting the intervention, and 8 weeks after starting the intervention
measure: The Parenting Stress Index-Short Form (PSI-SF) (Abidin, 1995)
timeFrame: before starting the intervention, 4 weeks after starting the intervention, and 8 weeks after starting the intervention
measure: Usability Survey
timeFrame: 8 weeks after starting the intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: New York University
name: Anil Chacko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Day JJ, Sanders MR. Do Parents Benefit From Help When Completing a Self-Guided Parenting Program Online? A Randomized Controlled Trial Comparing Triple P Online With and Without Telephone Support. Behav Ther. 2018 Nov;49(6):1020-1038. doi: 10.1016/j.beth.2018.03.002. Epub 2018 Mar 9.
citation: 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.
citation: Nieuwboer CC, Fukkink RG, Hermanns JM. Peer and professional parenting support on the Internet: a systematic review. Cyberpsychol Behav Soc Netw. 2013 Jul;16(7):518-28. doi: 10.1089/cyber.2012.0547. Epub 2013 May 9.
citation: 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.
citation: 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.
citation: 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.
citation: Evans SW, Owens JS, Wymbs BT, Ray AR. Evidence-Based Psychosocial Treatments for Children and Adolescents With Attention Deficit/Hyperactivity Disorder. J Clin Child Adolesc Psychol. 2018 Mar-Apr;47(2):157-198. doi: 10.1080/15374416.2017.1390757. Epub 2017 Dec 19.
citation: Wolraich ML, Hagan JF Jr, Allan C, Chan E, Davison D, Earls M, Evans SW, Flinn SK, Froehlich T, Frost J, Holbrook JR, Lehmann CU, Lessin HR, Okechukwu K, Pierce KL, Winner JD, Zurhellen W; SUBCOMMITTEE ON CHILDREN AND ADOLESCENTS WITH ATTENTION-DEFICIT/HYPERACTIVE DISORDER. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2019 Oct;144(4):e20192528. doi: 10.1542/peds.2019-2528.
citation: 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.
citation: Weisz JR, Kuppens S, Eckshtain D, Ugueto AM, Hawley KM, Jensen-Doss A. Performance of evidence-based youth psychotherapies compared with usual clinical care: a multilevel meta-analysis. JAMA Psychiatry. 2013 Jul;70(7):750-61. doi: 10.1001/jamapsychiatry.2013.1176.
citation: Cuffe SP, Moore CG, McKeown R. ADHD and health services utilization in the national health interview survey. J Atten Disord. 2009 Jan;12(4):330-40. doi: 10.1177/1087054708323248.
citation: McKay MM, Bannon WM Jr. Engaging families in child mental health services. Child Adolesc Psychiatr Clin N Am. 2004 Oct;13(4):905-21, vii. doi: 10.1016/j.chc.2004.04.001.