Digital Therapy Apps for Childhood Behavior Problems

Overseen By Abby Angus, BS

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

Disqualifiers: Bipolar, Major depression, Pervasive developmental, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Digital Therapy Apps for Childhood Behavior Problems?

Research shows that digital therapy apps can improve engagement and outcomes in treating child behavior problems. For example, a study found that a digital parent training program with enhanced design features led to better user engagement and improvements in child behavior compared to a standard program. ^{1 2 3 4 5}

Is there safety data available for digital therapy apps used for childhood behavior problems?

In a study on a smartphone app for adolescents, no adverse events were reported, suggesting it is generally safe. However, more research is needed to confirm safety across different apps and conditions. ^{6 7 8 9 10}

How is the SmilingMind and UseIt! App treatment different from other treatments for childhood behavior problems?

The SmilingMind and UseIt! App treatment is unique because it uses digital therapy apps, which are cost-efficient, scalable, and appealing to children, offering a novel way to address behavior problems compared to traditional in-person therapies. ^{2 4 6 10 11}

Research Team

Oliver Lindhiem, PhD

Principal Investigator

University of Pittsburgh, Department of Psychiatry

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Coach (Behavioural Intervention)
• SmilingMind App (Digital Therapeutics)
• UseIt! App (Digital Therapeutics)

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Smartphone app engagement and clinical outcomes in a hybrid clinic. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A Smartphone App for Parental Management of Adolescent Conduct Problems: Randomized Clinical Trial of iKinnect. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Adjuvant Therapy for Attention in Children with ADHD Using Game-Type Digital Therapy. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Development and Open Trial of a Technology-Enhanced Family Intervention for Adolescents at Risk for Mood Disorders. [2022]

5. Netherlands 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. [2023]

6. United States 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. [2022]

7. Ireland 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. [2021]

8. Ireland pubmed.ncbi.nlm.nih.gov

Smartphone-assisted psychoeducation in adult attention-deficit/hyperactivity disorder: A randomized controlled trial. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Attention-deficit/ hyperactivity disorder mobile apps: A systematic review. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Mobile-based interventions for common mental disorders in youth: a systematic evaluation of pediatric health apps. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Computer-Based and Online Therapy for Depression and Anxiety in Children and Adolescents. [2022]