Problem BehaviorNCT05647772
Digital Therapeutics for Behavior Problems
A study testing UseIt! App, Coach and SmilingMind App in people with Problem Behavior and Child Behavior, run by University of Pittsburgh at 1 site in United States.
Trial summary
In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Problem Behavior, Child Behavior
- What is being tested?
- UseIt! App, Coach and SmilingMind App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2022to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females between the ages of 5-8 years
- 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
- Parent/legal guardian consent for participation
- Parent/guardian must have a smartphone device with daily internet access
Who cannot join
- A known preexisting behavioral or mental health diagnosis requiring alternative treatment (bipolar disorder, major depression, pervasive developmental disorder)
- Currently in treatment for childhood disruptive behavior
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems
In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted app), or Group 3 (control app).
Read the detailed description
In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Aim 1 is to evaluate the effectiveness of the UseIt! mHealth system as both a standalone and coach-assisted intervention compared to a control app condition. Aim 2 is to assess target (parent management training/cognitive behavioral therapy skill acquisition and use) engagement and validation. Aim 3 is to evaluate the effectiveness of the components of the UseIt! mHealth system. The investigators plan to recruit an anticipated total of 324 families for the study. Families will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted), or Group 3 (control app condition). Parents will use the app for four months before the administration of the post-treatment assessment. Parents will be trained to use the UseIt! mHealth system over the phone. The coach for the Group 2 condition will be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who will provide support to parents. The system is very user friendly and families can be trained in approximately 30 minutes. Assessments will take place at Baseline, Post (4 months from baseline), and 6-month follow-up. All assessments will be conducted online (Qualtrics survey links sent via email by research staff) and take approximately 1 hour to complete.
- Conditions
- Problem Behavior, Child Behavior
- Being tested
- UseIt! App, Coach, SmilingMind App
- Keywords
- Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Childhood Behavioral Disorders, Mobile Health
- Medical subject headings
- Problem Behavior, Child Behavior, Oppositional Defiant Disorder, Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UseIt! AppBehavioural
The UseIt! app is a parenting app with evidence-based parent management content. The app runs on both Android and iOS devices. It includes a digital library of parent management skills, a trouble-shooting guide, a behavior diary, a point counter, and a skills-alarm.
CoachBehavioural
The coach is be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who provides support to parents. The coach will provide motivation and accountability but will not provide therapeutic/clinical support. The primary goal of the coach is to increase participant engagement with the UseIt! mHealth system.
SmilingMind AppBehavioural
The control app is a mindfulness app called SmilingMind. It is available for both Android and iOS devices.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standalone App | Experimental | Standalone parenting app called UseIt! Receives: Behavioral: UseIt! App |
| Group 2: App plus Coach | Experimental | Standalone parenting app called UseIt! plus a coach. Receives: Behavioral: UseIt! App; Behavioral: Coach |
| Group 3: Control App | Active comparator | Control condition: mindfulness app called SmilingMind. Receives: Behavioral: SmilingMind App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Effective Parenting Test (KEPT)
Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes.
Measured: Post assessment (4 months after baseline).
Knowledge of Effective Parenting Test (KEPT)
Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes.
Measured: 6-month follow-up (10 months after baseline).
Secondary outcomes (6)
Parenting Skill Use Diary (PSUD)
Average scores from the Parenting Skill Use Diary (PSUD). This is a proportion score (range 0 to 1), with higher scores indicating better outcomes.
Measured: Post assessment (4 months after baseline).
Parenting Skill Use Diary (PSUD)
Average scores from the Parenting Skill Use Diary (PSUD). This is a proportion score (range 0 to 1), with higher scores indicating better outcomes.
Measured: 6-month follow-up (10 months after baseline).
Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
Average scores from the Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 24, with higher scores indicating worse outcomes.
Measured: Post assessment (4 months after baseline).
Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
Average scores from the Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 24, with higher scores indicating worse outcomes.
Measured: 6-month follow-up (10 months after baseline).
Conduct Disorder Subscale of the Vanderbilt Assessment
Average scores from the Conduct Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 42, with higher scores indicating worse outcomes.
Measured: Post assessment (4 months after baseline).
Conduct Disorder Subscale of the Vanderbilt Assessment
Average scores from the Conduct Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 42, with higher scores indicating worse outcomes.
Measured: 6-month follow-up (10 months after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start3 Dec 2022
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Problem BehaviorStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized control trial. The investigators will use stratified randomization to ensure that the groups are equivalent on key clinical features. Randomization will take place after completion of the initial baseline assessment. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app; n = 108), Group 2 (coach-assisted app; n = 108), or Group 3 (control app; n = 108).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Oliver Lindhiem, University of Pittsburgh
- Investigators
- Oliver Lindhiem, PhD, Principal investigator, University of Pittsburgh, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647772
- Sponsor's protocol ID
- STUDY22030138
- Other IDs
- R01HD106930
- Status last verified
- Jun 2026
- First submitted
- 30 Nov 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected for this project will be made available to other researchers for future data mining, following publication of primary findings at the conclusion of the study. The investigators will share data with other investigators within and outside the University of Pittsburgh upon submission of a standardized written request. All data sharing will follow the guidelines and rules of the NIH and our IRB. Data (both raw data and summary scores) will be shared electronically (secure digital file) as de-identified data.
Publications
Lindhiem O, Tomlinson CS, Kolko DJ, Silk JS, Hafeman D, Wallace M, Setiawan IMA, Parmanto B. Novel Smartphone App and Supportive Accountability for the Treatment of Childhood Disruptive Behavior Problems: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 11;14:e67051. doi: 10.2196/67051.
PubMed 40068698
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reach and Scalability of Digital Therapeutics for Childhood Behavior Problems
- ClinicalTrials.gov ID
- NCT05647772
- Acronym / sponsor ID
- STUDY22030138
- Conditions
- Problem Behavior, Child Behavior
- Keywords
- Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Childhood Behavioral Disorders, Mobile Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Dec 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted app), or Group 3 (control app).
Detailed description
In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Aim 1 is to evaluate the effectiveness of the UseIt! mHealth system as both a standalone and coach-assisted intervention compared to a control app condition. Aim 2 is to assess target (parent management training/cognitive behavioral therapy skill acquisition and use) engagement and validation. Aim 3 is to evaluate the effectiveness of the components of the UseIt! mHealth system. The investigators plan to recruit an anticipated total of 324 families for the study. Families will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted), or Group 3 (control app condition). Parents will use the app for four months before the administration of the post-treatment assessment. Parents will be trained to use the UseIt! mHealth system over the phone. The coach for the Group 2 condition will be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who will provide support to parents. The system is very user friendly and families can be trained in approximately 30 minutes. Assessments will take place at Baseline, Post (4 months from baseline), and 6-month follow-up. All assessments will be conducted online (Qualtrics survey links sent via email by research staff) and take approximately 1 hour to complete.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- This study is a randomized control trial. The investigators will use stratified randomization to ensure that the groups are equivalent on key clinical features. Randomization will take place after completion of the initial baseline assessment. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app; n = 108), Group 2 (coach-assisted app; n = 108), or Group 3 (control app; n = 108).
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standalone App | Experimental | Behavioral: UseIt! AppStandalone parenting app called UseIt! |
| Group 2: App plus Coach | Experimental | Behavioral: UseIt! App, Behavioral: CoachStandalone parenting app called UseIt! plus a coach. |
| Group 3: Control App | Active comparator | Behavioral: SmilingMind AppControl condition: mindfulness app called SmilingMind. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males or females between the ages of 5-8 years
- 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
- Parent/legal guardian consent for participation
- Parent/guardian must have a smartphone device with daily internet access
Key exclusion criteria (2 listed)
- A known preexisting behavioral or mental health diagnosis requiring alternative treatment (bipolar disorder, major depression, pervasive developmental disorder)
- Currently in treatment for childhood disruptive behavior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UseIt! AppThe UseIt! app is a parenting app with evidence-based parent management content. The app runs on both Android and iOS devices. It includes a digital library of parent management skills, a trouble-shooting guide, a behavior diary, a point counter, and a skills-alarm. | Behavioural | Group 1: Standalone App, Group 2: App plus Coach |
| CoachThe coach is be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who provides support to parents. The coach will provide motivation and accountability but will not provide therapeutic/clinical support. The primary goal of the coach is to increase participant engagement with the UseIt! mHealth system. | Behavioural | Group 2: App plus Coach |
| SmilingMind AppThe control app is a mindfulness app called SmilingMind. It is available for both Android and iOS devices. | Behavioural | Group 3: Control App |
Primary outcome
Knowledge of Effective Parenting Test (KEPT)
Time frame: Post assessment (4 months after baseline).
Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes.
Knowledge of Effective Parenting Test (KEPT)
Time frame: 6-month follow-up (10 months after baseline).
Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes.
6 secondary outcomes
Parenting Skill Use Diary (PSUD)
Time frame: Post assessment (4 months after baseline).
Parenting Skill Use Diary (PSUD)
Time frame: 6-month follow-up (10 months after baseline).
Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
Time frame: Post assessment (4 months after baseline).
Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
Time frame: 6-month follow-up (10 months after baseline).
Conduct Disorder Subscale of the Vanderbilt Assessment
Time frame: Post assessment (4 months after baseline).
Conduct Disorder Subscale of the Vanderbilt Assessment
Time frame: 6-month follow-up (10 months after baseline).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 40068698Lindhiem O, Tomlinson CS, Kolko DJ, Silk JS, Hafeman D, Wallace M, Setiawan IMA, Parmanto B. Novel Smartphone App and Supportive Accountability for the Treatment of Childhood Disruptive Behavior Problems: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 11;14:e67051. doi: 10.2196/67051.
- Individual participant dataSharing planned: Yes. All data collected for this project will be made available to other researchers for future data mining, following publication of primary findings at the conclusion of the study. The investigators will share data with other investigators within and outside the University of Pittsburgh upon submission of a standardized written request. All data sharing will follow the guidelines and rules of the NIH and our IRB. Data (both raw data and summary scores) will be shared electronically (secure digital file) as de-identified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Lindhiem, PhD principal investigator
University of Pittsburgh, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UseIt! App, Coach and SmilingMind App in people with Problem Behavior and Child Behavior, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of Effective Parenting Test (KEPT) (time frame: Post assessment (4 months after baseline).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.