Digital Therapy Apps for Childhood Behavior Problems
Recruiting in Palo Alto (17 mi)
Overseen byOliver Lindhiem, PhD
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.
12345Is 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.
678910How 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.
2461011Eligibility 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
+2 more
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
Participant Groups
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.
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.
SmilingMind App is already approved in Australia for the following indications:
🇦🇺 Approved in Australia as SmilingMind for:
- Anxiety
- Depression
- Stress management
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Bellefield TowersPittsburgh, PA
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Who Is Running the Clinical Trial?
University of PittsburghLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Smartphone app engagement and clinical outcomes in a hybrid clinic. [2023]Despite the growing prevalence of mental health-related smartphone apps, low real-world engagement has prevented these apps from transforming the mental health landscape. Integrating mental health apps into more traditional therapeutic models appears to support better clinical outcomes, but also raises questions about the relationship between app engagement, the app itself, and the coach or clinician. This study explores patient app engagement patterns and the associated clinical outcomes gathered from piloting a digital clinic. Patients with anxiety or depression completed eight clinical visits and coach visits over a median of 83 days with a standard deviation of 17.25 days. Between clinical visits, patients completed therapeutic activities on the mindLAMP app. Mean PHQ-9 and GAD-7 scores decreased from the intake visit to both visit 4 and visit 8. Patients had high app engagement, but engagement did not correlate with outcomes. From intake visit to visit 4, the interaction effects indicate significant differences in the change of both PHQ-9 and GAD-7 depending on participants' average app satisfaction and clinician/coach satisfaction (as measured by WAI-SR) with engagement. Overall, results support the feasibility of incorporating an app into a hybrid clinic.
A Smartphone App for Parental Management of Adolescent Conduct Problems: Randomized Clinical Trial of iKinnect. [2022]This study evaluates iKinnect, a linked caregiver-teen mobile app system designed to address serious adolescent conduct problems through a focus on key targets of evidence-based treatments for juvenile offending, such as parent expectation setting, monitoring, consistency, and positive reinforcement. Additional gamification and autonomy-supporting features are designed to maximize youth engagement. Digital therapeutics such as mobile apps have great potential to expand access to effective interventions, particularly for youth who engage in serious conduct problems and substance abuse, since most never receive an evidence-based treatment and few apps exist for these concerns.
Adjuvant Therapy for Attention in Children with ADHD Using Game-Type Digital Therapy. [2023]Children diagnosed with attention deficit hyperactivity disorder (ADHD) require early intervention and sustained treatment. This study used a game-based digital treatment planning NeuroWorld DTx to analyze the impact on attention and cognitive function in children with ADHD. Thirty children diagnosed with ADHD were recruited and subjected to a four-week NeuroWorld DTx digital treatment. To assess the impact of the digital therapeutic therapy on children's attention, we used the comprehension attention test (CAT) and Korean ADHD Rating Scale (K-ARS). Clinical global impression (CGI) and the Korean-child behavior checklist (K-CBCL 6-18) were used to examine the degree of improvement in ADHD. After four weeks, significant differences in the sensitivity and response style indices were noted, as compared with the baseline in the CAT test; in the case of K-ARS and CGI, a moderate decrease in ADHD was confirmed. The study achieved better results for the "total behavior problems" belonging to the K-CBCL assessment. Game-based digital therapy intervention can be a treatment method that elicits interest and satisfaction in children with ADHD and can be used as an adjunct to drug therapy to improve the quality of life and strengthen attention in children with symptoms of ADHD.
Development and Open Trial of a Technology-Enhanced Family Intervention for Adolescents at Risk for Mood Disorders. [2022]Integrating psychosocial interventions with mobile apps may increase treatment engagement among adolescents. We examined the user experience, uptake, and clinical effects of a mobile-enhanced family-focused therapy (FFT) among adolescents at risk for mood disorders.
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]Understanding how to design engaging unguided digital health interventions is key in our ability to utilize digital tools to improve access to care. Therapeutic persuasiveness (TP) is a design concept that relates to how the digital intervention features as a whole should be designed to encourage users to make positive changes in their lives, while reducing the experienced effort required from them to engage in these activities. In our previous work, we examined the user traffic of publicly available programs, finding programs' TP quality to be a reliable, robust, and stable predictor of real-world usage; however, these findings have not been subject to experimental manipulation in a controlled trial. The current study examined the impact of TP quality in digital parent training programs (DPTs) aimed at treating child's behavior problems. We conducted a pilot randomized controlled trial comparing two interventions that utilize the same evidence-based content of established DPTs, but that differ in terms of the quality of TP (standard: DPT-STD; enhanced: DPT-TP). Altogether, parents from 88 families who have a child with behavior problems were enrolled in the study. Compared to DPT-STD (n = 43), participants allocated to DPT-TP (n = 45) used the program significantly more (ps < 0.001; Cohen's ds = 0.91-2.22). In terms of program completion, 68.9 % of DPT-TP participants completed it compared to 27.9 % of DPT-STD participants. Significant differences between the interventions were also found in reported improvements in child behavior problems favoring DPT-TP (ps < 0.05; Cohen's ds = 0.43-0.54). The results point to the importance of adequate product design and the utilization of conceptual frameworks in order to improve user engagement challenges.
A Smartphone App for Promoting Mental Well-being and Awareness of Anxious Symptoms in Adolescents: A Pilot Cluster Randomized Controlled Trial. [2022]Objective: To design a smartphone app and evaluate its effect on promoting mental well-being and awareness of anxious symptoms in adolescents. Materials and Methods: A pilot cluster randomized controlled trial was conducted with two secondary schools (390 students, mean age 13.1 years) randomized to the intervention and control groups. An app was designed to encourage "Sharing, Mind, and Enjoyment (SME)" between students and their parents (e.g., express gratitude), including interaction and game elements. The app was used daily over 1 month. The waitlist control group was offered the app after completing all assessments. The primary outcomes were changes in SME behaviors measured at 1 month and 3 months. Secondary outcomes included subjective happiness, well-being, personal health and happiness, family health, happiness and harmony, self-perceived knowledge, and understanding of anxious symptoms. Two focus groups of students and three individual in-depth interviews of community partners were conducted. Results: Seventeen of 152 students (11.2%) in the intervention group used the app together with parents (adherent subgroup) and 69 (45.4%) used it without involving parents. The intervention group did not show significant difference in the change of SME behaviors at 1- or 3-month follow-up compared with the control group. However, the intervention group reported greater increase in the awareness of anxious symptoms at follow-ups than the control group (d = 0.52 at 1 month and d = 0.43 at 3 month, both P < 0.001). Post hoc analysis showed a significantly greater increase in SME-related behaviors in the adherent subgroup than the control group at 3 months (d = 0.46, P = 0.04). The interviews found favorable changes in app users, but motivation to use the app was low in general. Both students and community partners suggested primary school students would be more receptive users. Conclusions: The app did not show effectiveness in increasing SME behaviors of students, but increased awareness of anxious symptoms. Further improvements and tests are warranted. Trial Registration: ClinicalTrials.gov NCT03361475.
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]The objective of this study is to compare game-based digital therapeutic device and other DHI like (smartphone apps, wearable technologies) for ADHD with the current pharmacological and behavior therapy. The FDA has approved a game-based digital therapeutic device - EndeavorRx, for the treatment of ADHD in pediatric patients belonging to the age group of 8-12 years old. This has been primarily recommended for the treatment of inattentive or combined-type ADHD who have demonstrated an attention issue. This is the first game-based therapeutic device to be approved by the FDA for any type of condition. According to the FDA, this has been shown to improve attention which is measured by computer-based testing. Objective: The objective of this study is to compare a game-based digital therapeutic device and other DHI (smartphone apps, wearable technologies) with the current pharmacological and behavior therapy used in the treatment of ADHD.
Smartphone-assisted psychoeducation in adult attention-deficit/hyperactivity disorder: A randomized controlled trial. [2022]Psychoeducation is generally recommended in the treatment of adult Attention-Deficit/Hyperactivity Disorder (ADHD), but only few studies have systematically assessed the effects of structured clinical psychoeducation. Moreover, although a considerable number of psychoeducational mobile applications exist, none have provided scientific evidence for their effectiveness or safety. Therefore, the present randomized controlled trial investigated a newly developed, free-to-use psychoeducation app for adults with ADHD as a support to a clinical psychoeducation group. 236 adults with ADHD were contacted for study participation, of whom 60 were finally randomized to a psychoeducation group supported either by our developed smartphone app (n = 30) or by traditional pen-and-paper brochures (n = 30). Psychoeducation treatments were conducted in groups of 10, with 8 weekly one-hour sessions between March 2019 and November 2020. Observer-rated ADHD symptom severity (IDA-R interview) was examined as the primary outcome parameter before and after treatment. Across both interventions, ADHD core symptoms were significantly reduced. Notably, the smartphone-assisted psychoeducation was significantly more effective in improving inattention and impulsivity and led to higher homework compliance than the brochure-assisted psychoeducation. No adverse events were reported.
Attention-deficit/ hyperactivity disorder mobile apps: A systematic review. [2020]Attention-Deficit/ Hyperactivity Disorder (ADHD) is a prevalent condition in children and adolescents. Although there are pharmacological and non-pharmacological treatments for this disorder, barriers in accessing evidence-based treatments are still a major problem. Digital health interventions are promising for multiple mental health problems. Recent years have brought an increase in the number of existing mobile apps designed for the management of ADHD. The aim of this study was to systematically review the existing mobile apps designed for ADHD in terms of general characteristics, empirical support for their development and efficacy/ effectiveness, and to describe the content and design of the four most downloaded ADHD apps.
Mobile-based interventions for common mental disorders in youth: a systematic evaluation of pediatric health apps. [2021]The access to empirically-supported treatments for common mental disorders in children and adolescents is often limited. Mental health apps might extend service supplies, as they are deemed to be cost-efficient, scalable and appealing for youth. However, little is known about the quality of available apps. Therefore, we aimed to systematically evaluate current mobile-based interventions for pediatric anxiety, depression and posttraumatic stress disorder (PTSD).
Computer-Based and Online Therapy for Depression and Anxiety in Children and Adolescents. [2022]The purpose of this study was to provide an overview of computer-based and online therapies (e-therapy) to treat children and adolescents with depression and/or anxiety, and to outline programs that are evidence based or currently being researched.