Digital Therapy Apps for Childhood Behavior Problems

Overseen By Abby Angus, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Bipolar, Major depression, Pervasive developmental, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

324 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two digital therapy apps designed to help parents manage children’s disruptive behaviors. Researchers aim to determine whether a standalone parenting app (UseIt! App) or an app with a coach is more effective compared to a mindfulness app (SmilingMind App). They seek to identify which method can be widely used and scaled up for more families. The trial suits parents of children aged 5-8 who frequently display oppositional behaviors and live with their parents most of the time. As an unphased trial, it offers parents the chance to contribute to innovative solutions for managing children's behaviors.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these digital therapy apps are safe for children with behavior problems?

Research has shown that the UseIt! App, whether used alone or with a coach, has been safe in past studies. One study on a similar app for teens reported no negative effects, suggesting the app is generally safe to use. However, researchers indicate that more studies are needed for confirmation.

Parents who have used similar apps mentioned challenges, such as practical issues and limited changes in their children's behavior. Despite these challenges, they found the app acceptable and suitable for their needs. Overall, current data does not highlight safety concerns, making the app a potentially safe choice for managing childhood behavior problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these digital therapy apps because they offer innovative approaches to addressing childhood behavior problems. Unlike traditional therapy options, which often require in-person sessions, the UseIt! app provides a convenient, standalone parenting tool that families can access anytime, anywhere. Additionally, the app-plus-coach option combines digital therapy with personalized guidance, offering a unique blend of technology and human support. Meanwhile, the SmilingMind app serves as a mindfulness-based control, highlighting the potential impact of integrating mindfulness practices into everyday life. These features make digital therapy apps a flexible, accessible, and potentially transformative option for families seeking behavioral support.

What evidence suggests that this trial's treatments could be effective for childhood behavior problems?

Research has shown that the UseIt! app, available to participants in this trial, helps parents manage their children's disruptive behaviors. This trial will evaluate the app both as a standalone tool and with coach support. Studies have found that both versions can reduce these behaviors. Parents using the app report that it helps them better handle their children's challenges. The app includes tools and a behavior diary to help parents track and address issues effectively. Early results suggest that a coach can enhance the app's effectiveness by providing personalized guidance. Overall, the UseIt! app is considered a potentially effective tool for managing childhood behavior problems. ^{1 6 7 8 9}

Who Is on the Research Team?

Oliver Lindhiem, PhD

Principal Investigator

University of Pittsburgh, Department of Psychiatry

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 5 and 8 years old.

Above the 90th percentile for Oppositional Defiant Disorder (ODD) and/or conduct disorders (CD) on the Vanderbilt Assessment Scale

Residence with at least one parent/guardian at least 80% of the time

Exclusion Criteria

Currently in treatment for childhood disruptive behavior

I have a diagnosed mental health condition like bipolar disorder or major depression.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Parents use the UseIt! mHealth system, either standalone or with coach assistance, for four months

16 weeks

Training over the phone, assessments online

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments conducted online

What Are the Treatments Tested in This Trial?

Interventions

• Coach
• SmilingMind App
• UseIt! App

Trial Overview

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.

How Is the Trial Designed?

Group I: Group 2: App plus Coach Experimental Treatment 2 Interventions

Standalone parenting app called UseIt! plus a coach.

Group II: Group 1: Standalone App Experimental Treatment 1 Intervention

Standalone parenting app called UseIt!

Group III: Group 3: Control App Active Control 1 Intervention

Control condition: mindfulness app called SmilingMind.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A systematic review identified 109 mobile apps designed for managing ADHD, targeting various users including children, adolescents, parents, and professionals, but very few provided evidence of their development or efficacy.

Despite the popularity of these apps, with some having up to 500,000 downloads, there is a significant lack of empirical support for their effectiveness, highlighting the need for further research to ensure their safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention-deficit/ hyperactivity disorder mobile apps: A systematic review. Păsărelu, CR., Andersson, G., Dobrean, A.[2020]

The smartphone app designed to promote mental well-being did not significantly increase 'Sharing, Mind, and Enjoyment' (SME) behaviors among adolescents, with only 11.2% of students using it with their parents, but it did enhance awareness of anxious symptoms significantly at both 1 and 3 months follow-up.

Post hoc analysis revealed that students who used the app with their parents showed a notable increase in SME-related behaviors at 3 months compared to the control group, suggesting that parental involvement may enhance the app's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone App for Promoting Mental Well-being and Awareness of Anxious Symptoms in Adolescents: A Pilot Cluster Randomized Controlled Trial. Sun, Y., Wang, MP., Ho, SY., et al.[2022]

There is growing evidence that computer-based and online therapies (e-therapy) are effective in treating depression and anxiety in children and adolescents, supported by randomized controlled trials.

While many programs show promise, further research is needed to confirm their long-term effectiveness and to ensure that new e-therapy programs align with technological advancements for better engagement and delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Based and Online Therapy for Depression and Anxiety in Children and Adolescents. Stasiak, K., Fleming, T., Lucassen, MF., et al.[2022]

The FDA has approved EndeavorRx, a game-based digital therapeutic device, as the first of its kind for treating ADHD in children aged 8-12, specifically targeting inattentive or combined-type ADHD.

EndeavorRx has been shown to improve attention in pediatric patients, as measured by computer-based testing, indicating its potential efficacy as a non-pharmacological treatment option alongside traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health interventions (DHI) for the treatment of attention deficit hyperactivity disorder (ADHD) in children - a comparative review of literature among various treatment and DHI. Pandian, GSB., Jain, A., Raza, Q., et al.[2021]

Patients with anxiety or depression showed significant reductions in their symptoms, as measured by PHQ-9 and GAD-7 scores, after using the mindLAMP app in conjunction with clinical visits over a median of 83 days.

High engagement with the app did not directly correlate with better clinical outcomes, suggesting that factors like patient satisfaction with the app and clinician support may play a more critical role in treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone app engagement and clinical outcomes in a hybrid clinic. Chang, S., Gray, L., Torous, J.[2023]

A pilot randomized controlled trial with 88 families showed that a digital parent training program (DPT-TP) designed with higher therapeutic persuasiveness led to significantly greater usage and completion rates compared to a standard version (DPT-STD), with 68.9% of DPT-TP participants completing the program versus only 27.9% for DPT-STD.

Participants using the DPT-TP also reported greater improvements in their child's behavior problems, highlighting the effectiveness of well-designed digital interventions in promoting positive behavioral changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of therapeutic persuasiveness on engagement and outcomes in unguided interventions: A randomized pilot trial of a digital parent training program for child behavior problems. Baumel, A., Brandes, O., Brendryen, H., et al.[2023]

A pilot study involving 22 adolescents and their parents showed that integrating a mobile app with family-focused therapy (FFT) led to significant improvements in depression scores over 27 weeks, indicating the potential efficacy of this approach.

Participants engaged with the app, completing 46%-65% of assessments and skill practices, and reported reduced parental criticism, suggesting that mobile apps can enhance treatment engagement and provide valuable feedback for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Open Trial of a Technology-Enhanced Family Intervention for Adolescents at Risk for Mood Disorders. Miklowitz, DJ., Weintraub, MJ., Posta, F., et al.[2022]

A randomized controlled trial involving 60 adults with ADHD showed that a newly developed psychoeducation app significantly improved inattention and impulsivity compared to traditional pen-and-paper brochures.

Both psychoeducation methods reduced ADHD symptoms, but the app-assisted group demonstrated better homework compliance and no adverse events were reported, indicating its safety and efficacy as a treatment support tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-assisted psychoeducation in adult attention-deficit/hyperactivity disorder: A randomized controlled trial. Selaskowski, B., Steffens, M., Schulze, M., et al.[2022]

Out of 3806 mental health apps identified, only 15 (0.39%) met the criteria for targeting anxiety, depression, or PTSD in youth, indicating a significant lack of quality options available for young users.

The overall quality of the eligible apps was moderate, with a mean score of 3.59 on the Mobile App Rating Scale, and only one app had been evaluated in a randomized controlled trial, highlighting the need for more rigorous scientific evaluation and development of mental health apps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile-based interventions for common mental disorders in youth: a systematic evaluation of pediatric health apps. Domhardt, M., Messner, EM., Eder, AS., et al.[2021]

The iKinnect app system significantly reduced alcohol and marijuana use, school delinquency, and general delinquency among teens over a 12-week period, compared to a control app, indicating its efficacy in addressing serious conduct problems.

Parents using iKinnect reported improved clarity in rules and consistency in discipline, suggesting that the app not only benefits teens but also enhances parenting practices, which is crucial for effective intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone App for Parental Management of Adolescent Conduct Problems: Randomized Clinical Trial of iKinnect. Schaeffer, CM., Dimeff, LA., Koerner, K., et al.[2022]

A four-week game-based digital treatment called NeuroWorld DTx significantly improved attention and cognitive function in 30 children with ADHD, as measured by various assessments including the comprehension attention test (CAT) and Korean ADHD Rating Scale (K-ARS).

The study found a moderate decrease in ADHD symptoms and improved behavior problems, suggesting that digital therapy can be an engaging adjunct to traditional drug treatments, enhancing the overall quality of life for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant Therapy for Attention in Children with ADHD Using Game-Type Digital Therapy. Kim, SC., Lee, H., Lee, HS., et al.[2023]

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