RECRUITING

Randomized Controlled Trial of a Behavioral Training App

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Controlled Trial of a Behavioral Training App

Quick Facts

Study Start:2024-03-27

Study Completion:2024-10-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06447909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Anil Chacko, PhD

CONTACT

(212) 998-5749

ac5489@nyu.edu

Principal Investigator

Anil Chacko, PhD

PRINCIPAL_INVESTIGATOR

New York University

Study Locations (Sites)

New York University

New York, New York, 10003

United States

Collaborators and Investigators

Sponsor: New York University

Anil Chacko, PhD, PRINCIPAL_INVESTIGATOR, New York University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-27

Study Completion Date2024-10-30

Study Record Updates

Study Start Date2024-03-27

Study Completion Date2024-10-30

Terms related to this study

Additional Relevant MeSH Terms

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