ClinicalTrials.gg
Active, not recruitingNCT05647772Updated Nov 5, 2026

Digital Therapeutics for Behavior Problems

An interventional study of UseIt! App and Coach in Problem Behavior and Child Behavior, sponsored by University of Pittsburgh. Active, not recruiting at 1 site in United States. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research

Updated Nov 5, 2026Primary completion movedStudy completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
324
Allocation
Randomized
Ages
5 Years to 8 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Problem Behavior
  • Child Behavior

Keywords

  • Oppositional Defiant Disorder (ODD)
  • Conduct Disorder (CD)
  • Childhood Behavioral Disorders
  • Mobile Health
03

In context

Problem Behavior

178 studies on the registry are indexed under Problem Behavior; 47 are open to participants now.

This study's enrollment of 324 is above the median of 90 across 165 interventional studies indexed under Problem Behavior.

Browse Problem Behavior studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
324 participants (actual)

Study arms

  • Experimental
    Group 1: Standalone App

    Standalone parenting app called UseIt!

    Behavioral: UseIt! App

  • Experimental
    Group 2: App plus Coach

    Standalone parenting app called UseIt! plus a coach.

    Behavioral: UseIt! App · Behavioral: Coach

  • Active comparator
    Group 3: Control App

    Control condition: mindfulness app called SmilingMind.

    Behavioral: SmilingMind App

Interventions

  • BehavioralUseIt! App

    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.

  • BehavioralCoach

    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.

  • BehavioralSmilingMind App

    The control app is a mindfulness app called SmilingMind. It is available for both Android and iOS devices.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Post assessment (4 months after baseline).

  2. 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.

    Time frame: 6-month follow-up (10 months after baseline).

Secondary outcomes

  1. 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.

    Time frame: Post assessment (4 months after baseline).

  2. 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.

    Time frame: 6-month follow-up (10 months after baseline).

  3. 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.

    Time frame: Post assessment (4 months after baseline).

  4. 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.

    Time frame: 6-month follow-up (10 months after baseline).

  5. 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.

    Time frame: Post assessment (4 months after baseline).

  6. 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.

    Time frame: 6-month follow-up (10 months after baseline).

07

Study locations

1 site
08

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol

Time frame: Following publication of primary findings at the conclusion of the study.

Access criteria: To gain access, anyone not part of the original research protocol will submit a Data Analysis Request Form which requires elucidation of hypotheses to be tested and specific data requested. This form requires information about the investigator, including institutional affiliation, resume, proposed research, and conflict of interest statement. The investigator must document completion of the University of Pittsburgh Certification Program in Research Practice Fundamentals or a comparable training program at their own institution. Investigators outside the University of Pittsburgh must also complete a Data Use and Confidentiality Agreement before release of data to them.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2022 (actual). Primary completion is estimated for Feb 2027, 50 months after the start.

Of 111 non-industry interventional studies with no phase under Problem Behavior, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 50 months is above that.

Counting every sponsor, half of 112 studies reached it within 24 months; a quarter within 13 and three quarters within 51.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: primary completion Oct 2026 → Feb 2027 and completion Apr 2027 → Feb 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2022
First posted
Dec 12, 2022
StartActual
Dec 3, 2022
Primary completionEst.
Feb 2027was Oct 2026
CompletionEst.
Feb 2027was Apr 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Oct 2026→Feb 2027
Nov 5, 2026
Study completion
Apr 2027→Feb 2027
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Primary completion Oct 2026→Feb 2027
    Study completion Apr 2027→Feb 2027

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05647772
Responsible party
Oliver Lindhiem (Associate Professor, University of Pittsburgh) — Principal investigator
First posted
Dec 12, 2022
Start date
Dec 3, 2022
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Oliver Lindhiem, PhD
principal investigator · University of Pittsburgh, Department of Psychiatry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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