What side effects are associated with this type of intervention?

Digital health technologies for managing disruptive behaviors, such as mHealth systems, are generally well-tolerated with minimal physical side effects. Potential issues include increased screen time leading to eye strain or sleep disturbances, and reduced face-to-face social interactions. Behavioral interventions like CBT delivered digitally may cause initial discomfort as individuals confront challenging behaviors and thoughts, and there may be variability in engagement and adherence to the intervention.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of disruptive behaviors, particularly in conditions like ADHD, which often present with disruptive symptoms. Commonly approved medications include stimulants such as methylphenidate (Ritalin) and amphetamine (Adderall), as well as non-stimulants like atomoxetine (Strattera). While digital health technologies like mHealth systems are emerging as promising tools for managing disruptive behaviors, they typically complement rather than replace pharmacological treatments. These digital interventions often focus on behavior modification and support, leveraging mobile apps and text messaging to enhance treatment adherence and provide real-time feedback.

What other types of research exist?

Promising alternatives to mHealth systems for managing disruptive behaviors in 2024 include: 1) Cognitive-behavioral therapy (CBT) delivered through traditional face-to-face sessions or guided self-help formats. 2) Pharmacological treatments tailored to individual needs, such as medications targeting specific symptoms. 3) Integrative approaches combining behavioral therapy with lifestyle interventions like mindfulness and physical activity programs. 4) Emerging technologies like virtual reality (VR) therapy and biofeedback devices. These alternatives offer a range of options that can be customized to patient preferences and clinical requirements.

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Digital Therapeutics

Digital Therapy Apps for Childhood Behavior Problems

N/A

Recruiting

Led By Oliver Lindhiem, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-month follow-up (10 months after baseline).

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a smartphone app called UseIt! to help parents manage their children's disruptive behaviors. The app can be used alone or with help from a coach. It teaches parents effective behavior management techniques.

Who is the study for?

This trial is for children aged 5-8 who often show disruptive behaviors and live with a parent most of the time. The child must score high on a behavior scale, and their parent needs to have a smartphone with daily internet. Kids already in treatment or with certain mental health conditions can't join.

What is being tested?

The study tests an mHealth system's effectiveness for managing childhood behavior problems using two apps: UseIt! App alone, UseIt! App with coach assistance, versus SmilingMind (control). Parents are randomly placed into one of these three groups.

What are the potential side effects?

Since this trial involves digital apps and coaching rather than medication, traditional physical side effects aren't expected. However, there may be indirect effects like increased screen time or potential frustration if the app doesn't improve behaviors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-month follow-up (10 months after baseline).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-month follow-up (10 months after baseline).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month follow-up (10 months after baseline). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Knowledge of Effective Parenting Test (KEPT)

Secondary study objectives

Conduct Disorder Subscale of the Vanderbilt Assessment

Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment

Parenting Skill Use Diary (PSUD)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 2: App plus CoachExperimental Treatment2 Interventions

Standalone parenting app called UseIt! plus a coach.

Group II: Group 1: Standalone AppExperimental Treatment1 Intervention

Standalone parenting app called UseIt!

Group III: Group 3: Control AppActive Control1 Intervention

Control condition: mindfulness app called SmilingMind.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for disruptive behaviors include cognitive-behavioral interventions and digital health technologies such as mobile health (mHealth) systems. These treatments work by providing structured behavioral strategies and real-time feedback to help patients manage their behaviors. Cognitive-behavioral interventions focus on changing negative thought patterns and behaviors through techniques like cognitive rehearsal and skills training. Digital health technologies enhance these interventions by offering accessible, scalable, and instant support through mobile apps, which can include features like goal setting, progress tracking, and personalized feedback. These mechanisms are crucial for patients with disruptive behaviors as they provide continuous support and reinforcement, making it easier to implement and maintain positive behavior changes in daily life.

Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation.Behavior Change Content, Understandability, and Actionability of Chronic Condition Self-Management Apps Available in France: Systematic Search and Evaluation.Responding to disruptive behaviors in nursing: A longitudinal, quasi-experimental investigation of training for nursing students.