Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447909
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-28
Brief Title:
Randomized Controlled Trial of a Behavioral Training App
Sponsor:
New York University
Organization:
New York University
Study Overview
Official Title:
Randomized Controlled Trial of a Behavioral Training App
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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-deficithyperactivity disorder ADHD and other disruptive behavior disorders DBDs ie conduct disorder CD and oppositional defiant disorderODD 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 attitudesbeliefs 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 andor 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 participants 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 eg 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
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 attitudesbeliefs 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 andor 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 participants 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None