Attention Deficit Hyperactivity DisorderNCT06012851
Mobile Behavioral Parent Training for Childhood ADHD: A Micro-randomized Trial
A study testing Mobile behavioral parent training (mBPT), In the moment feedback and In the moment suggestions in people with Attention Deficit Hyperactivity Disorder, run by Florida International University at 1 site in United States.
Trial summary
The goal of the study is to develop and refine a personalized behavioral parent training intervention for caregivers of children with attention deficit hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Mobile behavioral parent training (mBPT), In the moment feedback and In the moment suggestions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 23 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- N/A
- Caregiver Participant Inclusion Criterion:
- 18 years old or older
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Children and Families of Western New York
Buffalo, New York, 14226
About this study
Official title: Personalizing Behavioral Parent Training: Improving Reach and Outcomes for Families of Children With Attention Deficit Hyperactivity Disorder (ADHD)
The goal of the study is to develop and refine a personalized behavioral parent training intervention for caregivers of children with attention deficit hyperactivity disorder (ADHD). The behavioral intervention will teach positive parenting through videos and quizzes that caregivers can access through a smartphone application. The program also gives parents and caregivers in-the-moment feedback their use of parenting strategies. The current study, a micro-randomized trial, aims to see whether the in-the-moment feedback given to parents (a push notification on their smartphone) changes parenting behavior right after the feedback. Micro-randomized means that parents are randomly assigned repeatedly, in this study multiple times per day, to receive or not receive parenting feedback or suggestions on their smartphones.
The main questions to answer are:
Is parenting feedback provided by a smartphone application acceptable to caregivers? When parents receive the feedback, do they use more positive parenting skills in the next few minutes compared to when they do not receive the feedback? Is the phone application usable and acceptable to parents and caregivers of children with attention deficit hyperactivity disorder?
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Mobile behavioral parent training (mBPT), In the moment feedback, In the moment suggestions
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile behavioral parent training (mBPT)Behavioural
The mobile phone application includes behavioral parent training content (for example, praise, effective commands, reward systems) delivered in videos, examples, and quizzes that parents/caregivers access.
In the moment feedbackBehavioural
In-the-moment feedback will include parenting feedback.
In the moment suggestionsBehavioural
In-the-moment feedback will include suggestions for parenting strategies.
| Study group | Role | What they receive |
|---|---|---|
| Mobile BPT with in-the-moment feedback | Experimental | Participants will be randomized multiple times per day to receive a push notification that provides feedback about parenting. Receives: Behavioral: Mobile behavioral parent training (mBPT); Behavioral: In the moment feedback |
| Mobile BPT with in-the-moment suggestions | Experimental | Participants will be randomized multiple times per day to receive a push notification that provides a suggestion for a parenting behavior. Receives: Behavioral: Mobile behavioral parent training (mBPT); Behavioral: In the moment suggestions |
| Mobile BPT only | Other | Participants will be randomized multiple times per day to receive no push notification. Receives: Behavioral: Mobile behavioral parent training (mBPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive Audio Data-Positive Sentiment Analysis
Parent and child interaction behavior- proportion of recorded interaction that is labeled positive via sentiment analysis algorithm. This will be assessed during scheduled, daily audio recordings. Specifically, we will assess sentiment after the randomization of prompt delivery and prior to the next randomization.
Measured: Through study completion, average of 5 weeks
Passive Audio Data-Negative Sentiment Analysis
Parent and child interaction behavior- proportion of recorded interaction that is labeled negative via sentiment analysis algorithm. This will be assessed during scheduled, daily audio recordings. Specifically, we will assess sentiment after the randomization of prompt delivery and prior to the next randomization.
Measured: Throughout study completion, average of 5 weeks
Secondary outcomes (1)
Intervention Engagement
Number of mobile BPT sessions completed divided by the total number of sessions available.
Measured: Through study completion, average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Apr 2024
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants receive access to a beta version of the mobile behavioral parent training application. Each participant is randomized multiple times per day (about 4-6 times per day) to received either no push notification (50% chance) or a push notification providing parenting feedback or a suggestion to use a parenting strategy (50% chance).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012851
- Sponsor's protocol ID
- 1R34MH128513-01
- Status last verified
- Dec 2024
- First submitted
- 22 Aug 2023
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Behavioral Parent Training: Improving Reach and Outcomes for Families of Children With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT06012851
- Acronym / sponsor ID
- 1R34MH128513-01
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 28 Aug 2023 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to develop and refine a personalized behavioral parent training intervention for caregivers of children with attention deficit hyperactivity disorder (ADHD). The behavioral intervention will teach positive parenting through videos and quizzes that caregivers can access through a smartphone application. The program also gives parents and caregivers in-the-moment feedback their use of parenting strategies. The current study, a micro-randomized trial, aims to see whether the in-the-moment feedback given to parents (a push notification on their smartphone) changes parenting behavior right after the feedback. Micro-randomized means that parents are randomly assigned repeatedly, in this study multiple times per day, to receive or not receive parenting feedback or suggestions on their smartphones.
The main questions to answer are:
Is parenting feedback provided by a smartphone application acceptable to caregivers? When parents receive the feedback, do they use more positive parenting skills in the next few minutes compared to when they do not receive the feedback? Is the phone application usable and acceptable to parents and caregivers of children with attention deficit hyperactivity disorder?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- All participants receive access to a beta version of the mobile behavioral parent training application. Each participant is randomized multiple times per day (about 4-6 times per day) to received either no push notification (50% chance) or a push notification providing parenting feedback or a suggestion to use a parenting strategy (50% chance).
| Arm | Type | Receives |
|---|---|---|
| Mobile BPT with in-the-moment feedback | Experimental | Behavioral: Mobile behavioral parent training (mBPT), Behavioral: In the moment feedbackParticipants will be randomized multiple times per day to receive a push notification that provides feedback about parenting. |
| Mobile BPT with in-the-moment suggestions | Experimental | Behavioral: Mobile behavioral parent training (mBPT), Behavioral: In the moment suggestionsParticipants will be randomized multiple times per day to receive a push notification that provides a suggestion for a parenting behavior. |
| Mobile BPT only | Other | Behavioral: Mobile behavioral parent training (mBPT)Participants will be randomized multiple times per day to receive no push notification. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- N/A
- 18 years old or older
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 |
|---|---|---|
| Mobile behavioral parent training (mBPT)The mobile phone application includes behavioral parent training content (for example, praise, effective commands, reward systems) delivered in videos, examples, and quizzes that parents/caregivers access. | Behavioural | Mobile BPT only, Mobile BPT with in-the-moment feedback, Mobile BPT with in-the-moment suggestions |
| In the moment feedbackIn-the-moment feedback will include parenting feedback. | Behavioural | Mobile BPT with in-the-moment feedback |
| In the moment suggestionsIn-the-moment feedback will include suggestions for parenting strategies. | Behavioural | Mobile BPT with in-the-moment suggestions |
Primary outcome
Passive Audio Data-Positive Sentiment Analysis
Time frame: Through study completion, average of 5 weeks
Parent and child interaction behavior- proportion of recorded interaction that is labeled positive via sentiment analysis algorithm. This will be assessed during scheduled, daily audio recordings. Specifically, we will assess sentiment after the randomization of prompt delivery and prior to the next randomization.
Passive Audio Data-Negative Sentiment Analysis
Time frame: Throughout study completion, average of 5 weeks
Parent and child interaction behavior- proportion of recorded interaction that is labeled negative via sentiment analysis algorithm. This will be assessed during scheduled, daily audio recordings. Specifically, we will assess sentiment after the randomization of prompt delivery and prior to the next randomization.
1 secondary outcome
Intervention Engagement
Time frame: Through study completion, average of 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile behavioral parent training (mBPT), In the moment feedback and In the moment suggestions in people with Attention Deficit Hyperactivity Disorder, run by Florida International University 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 0 inclusion and 3 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: finished, as of the sponsor's last update on 29 Apr 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?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Passive Audio Data-Positive Sentiment Analysis (time frame: Through study completion, average of 5 weeks). 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?
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 29 Apr 2026.