Digital Therapeutics for Behavior Problems (NCT05647772) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Digital Therapeutics for Behavior Problems
United States324 participantsStarted 2022-12-03
Plain-language 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).
Who can participate
Age range
5 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on measuring parenting knowledge using something called the Knowledge of Effective Parenting Test — can you explain what that means for my child's actual behavior, and whether improving my parenting knowledge is likely to make a meaningful difference for the specific behavior problems we're dealing with?
2Since this study is listed as 'active not recruiting,' my child can't enroll right now — but are there similar digital or app-based parenting programs you'd recommend we look into in the meantime, or other evidence-based options we could start with?
3This trial is listed as Phase NA, which I think means it's studying a behavioral or digital intervention rather than a drug — does that change the risk picture compared to other types of trials, and what would participation typically have involved in terms of time and commitment for a parent?
4How does a digital therapeutics approach like this one compare to working directly with a child therapist or behavioral specialist for my child's behavior problems — is one likely to be more effective than the other for our situation?
5If this trial eventually publishes its results, how will I know whether the findings are relevant to my child's specific type of behavior challenges, since 'problem behavior' can mean very different things depending on the child?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Knowledge of Effective Parenting Test (KEPT)
Timeframe: Post assessment (4 months after baseline).
2
Knowledge of Effective Parenting Test (KEPT)
Timeframe: 6-month follow-up (10 months after baseline).