Trial Outcomes & Findings for Mobile Behavioral Parent Training for Childhood ADHD: A Micro-randomized Trial (NCT NCT06012851)
NCT ID: NCT06012851
Last Updated: 2026-04-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Through study completion, average of 5 weeks
Results posted on
2026-04-29
Participant Flow
Participants were recruited in 2024 via social media advertising, e-mail contact lists, community partnerships, area pediatric offices, local schools and other methods. 185 families were screened, 133 were interested and potentially eligible, 50 families provided consent for study and eligibility evaluation, and 16 were excluded due to not completing intake forms, being unreachable, declining participation, or being ineligible resulting in 34 enrolled.
Prior to assignment, participants downloaded the phone application. Participants that were not successful in downloading and launching the application (n = 7) due to a variety of reasons spanning technical, user specific, or personal, were never micro-randomized or assigned to a condition. Nor could they provide feedback regarding intervention content. Resulting in data for 27 participating dyads.
Participant milestones
| Measure |
Mobile BPT With Randomized Micro-interventions
All participants received access to a smartphone based application that provided asynchronous behavioral parent training content. Additionally, they completed audio-recordings up to twice per day, and during audio recording sessions, participating dyads were randomized every 6-minutes to receive either no notification (i.e., no micro-intervention, 50% chance), a notification that provided a personalized suggestion for a parenting behavior (25%), or a notification that provided personalized feedback about parenting or parent/child interaction (25%).
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|---|---|
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Overall Study
STARTED
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27
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Overall Study
Completed at least one audio recording session
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26
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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7
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Reasons for withdrawal
| Measure |
Mobile BPT With Randomized Micro-interventions
All participants received access to a smartphone based application that provided asynchronous behavioral parent training content. Additionally, they completed audio-recordings up to twice per day, and during audio recording sessions, participating dyads were randomized every 6-minutes to receive either no notification (i.e., no micro-intervention, 50% chance), a notification that provided a personalized suggestion for a parenting behavior (25%), or a notification that provided personalized feedback about parenting or parent/child interaction (25%).
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|---|---|
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Overall Study
Withdrawal by Subject
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4
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Overall Study
Lost to Follow-up
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3
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Baseline Characteristics
54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
Baseline characteristics by cohort
| Measure |
Mobile BPT With Randomized Micro-interventions
n=54 Participants
All participants received access to a smartphone based application that provided asynchronous behavioral parent training content. Additionally, they completed audio-recordings up to twice per day, and during audio recording sessions, participating dyads were randomized every 6-minutes to receive either no notification (i.e., no micro-intervention, 50% chance), a notification that provided a personalized suggestion for a parenting behavior (25%), or a notification that provided personalized feedback about parenting or parent/child interaction (25%).
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|---|---|
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Age, Continuous
Child Participants
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9 Years
STANDARD_DEVIATION 1.59 • n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
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Age, Continuous
Adult Caregiver Participants
|
42.30 Years
STANDARD_DEVIATION 5.32 • n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
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Sex: Female, Male
Child Participants · Female
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10 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
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Sex: Female, Male
Child Participants · Male
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17 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
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Sex: Female, Male
Adult Caregiver Participants · Female
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25 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
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Sex: Female, Male
Adult Caregiver Participants · Male
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2 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
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Race (NIH/OMB)
Child Participants · American Indian or Alaska Native
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1 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Child Participants · Asian
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0 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Child Participants · Native Hawaiian or Other Pacific Islander
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0 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Child Participants · Black or African American
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3 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Child Participants · White
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23 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Child Participants · More than one race
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0 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Child Participants · Unknown or Not Reported
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0 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Adult Caregiver Participants · American Indian or Alaska Native
|
0 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Adult Caregiver Participants · Asian
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0 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Adult Caregiver Participants · Native Hawaiian or Other Pacific Islander
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0 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Adult Caregiver Participants · Black or African American
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2 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Adult Caregiver Participants · White
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23 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Adult Caregiver Participants · More than one race
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0 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Race (NIH/OMB)
Adult Caregiver Participants · Unknown or Not Reported
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2 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) Participants were able to select more than one race, and entering them as multiracial here necessitates removing them from their racial categories. Note 4 children were identified as multiracial and 0 adults reported multiple racial categories.
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Ethnicity (NIH/OMB)
Child Participants · Hispanic or Latino
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6 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
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Ethnicity (NIH/OMB)
Child Participants · Not Hispanic or Latino
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21 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
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Ethnicity (NIH/OMB)
Child Participants · Unknown or Not Reported
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0 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
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Ethnicity (NIH/OMB)
Adult Caregiver Participants · Hispanic or Latino
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6 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
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Ethnicity (NIH/OMB)
Adult Caregiver Participants · Not Hispanic or Latino
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21 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
|
|
Ethnicity (NIH/OMB)
Adult Caregiver Participants · Unknown or Not Reported
|
0 Participants
n=27 Participants • 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27)
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PRIMARY outcome
Timeframe: Through study completion, average of 5 weeksPopulation: The 26 participants included are the same across study arms. This is a within-subjects trial with multiple randomizations per day during audio-recording sessions for participating subjects. The sample size is 26 because one of the 27 participants who successfully enrolled and downloaded the application did not complete any audio sessions and therefore was never randomized in the micro-randomized trial.
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.
Outcome measures
| Measure |
Personalized In-the-moment Parenting Feedback
n=26 Participants
Participants completed 30-minute audio-recording sessions that they could initiate up to twice daily throughout the study. During audio-recording sessions, participants were randomized multiple times (every 6 minutes) to receive a notification or not, and 25% of the time the notification provided feedback about parenting.
All participants received access to a smartphone based application that provided asynchronous behavioral parent training content.
|
No Micro-intervention in the Moment
n=26 Participants
Participants completed 30-minute audio-recording sessions that they could initiate up to twice daily throughout the study. During audio-recording sessions, participants were randomized multiple times (every 6 minutes) to receive a notification or not with 50% assignment to the no micro-intervention condition.
All participants received access to a smartphone based application that provided asynchronous behavioral parent training content.
|
Personalized In-the-moment Parenting Suggestions
n=26 Participants
Participants completed 30-minute audio-recording sessions that they could initiate up to twice daily throughout the study. During audio-recording sessions, participants were randomized multiple times (every 6 minutes) to receive a notification or not, and 25% of the time the notification provided a suggestion or parenting strategy.
All participants received access to a smartphone based application that provided asynchronous behavioral parent training content.
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|---|---|---|---|
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Passive Audio Data-Positive Sentiment Analysis
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0.369 Proportion Positive Sentiment
Standard Deviation 0.483
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0.388 Proportion Positive Sentiment
Standard Deviation 0.488
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0.409 Proportion Positive Sentiment
Standard Deviation 0.492
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PRIMARY outcome
Timeframe: Throughout study completion, average of 5 weeksPopulation: The 26 participants included are the same across study arms. This is a within-subjects trial with multiple randomizations per day during audio-recording sessions for participating subjects. The sample size is 26 because one of the 27 participants who successfully enrolled and downloaded the application did not complete any audio sessions and therefore was never randomized in the micro-randomized trial.
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.
Outcome measures
| Measure |
Personalized In-the-moment Parenting Feedback
n=26 Participants
Participants completed 30-minute audio-recording sessions that they could initiate up to twice daily throughout the study. During audio-recording sessions, participants were randomized multiple times (every 6 minutes) to receive a notification or not, and 25% of the time the notification provided feedback about parenting.
All participants received access to a smartphone based application that provided asynchronous behavioral parent training content.
|
No Micro-intervention in the Moment
n=26 Participants
Participants completed 30-minute audio-recording sessions that they could initiate up to twice daily throughout the study. During audio-recording sessions, participants were randomized multiple times (every 6 minutes) to receive a notification or not with 50% assignment to the no micro-intervention condition.
All participants received access to a smartphone based application that provided asynchronous behavioral parent training content.
|
Personalized In-the-moment Parenting Suggestions
n=26 Participants
Participants completed 30-minute audio-recording sessions that they could initiate up to twice daily throughout the study. During audio-recording sessions, participants were randomized multiple times (every 6 minutes) to receive a notification or not, and 25% of the time the notification provided a suggestion or parenting strategy.
All participants received access to a smartphone based application that provided asynchronous behavioral parent training content.
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|---|---|---|---|
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Passive Audio Data-Negative Sentiment Analysis
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0.327 Proportion Negative Sentiment
Standard Deviation 0.470
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0.305 Proportion Negative Sentiment
Standard Deviation 0.461
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0.296 Proportion Negative Sentiment
Standard Deviation 0.457
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SECONDARY outcome
Timeframe: Through study completion, average of 5 weeksPopulation: The sample size of 27 includes all caregivers who enrolled in the study and successfully downloaded the smartphone application.
Number of mobile BPT sessions completed divided by the total number of sessions available.
Outcome measures
| Measure |
Personalized In-the-moment Parenting Feedback
Participants completed 30-minute audio-recording sessions that they could initiate up to twice daily throughout the study. During audio-recording sessions, participants were randomized multiple times (every 6 minutes) to receive a notification or not, and 25% of the time the notification provided feedback about parenting.
All participants received access to a smartphone based application that provided asynchronous behavioral parent training content.
|
No Micro-intervention in the Moment
Participants completed 30-minute audio-recording sessions that they could initiate up to twice daily throughout the study. During audio-recording sessions, participants were randomized multiple times (every 6 minutes) to receive a notification or not with 50% assignment to the no micro-intervention condition.
All participants received access to a smartphone based application that provided asynchronous behavioral parent training content.
|
Personalized In-the-moment Parenting Suggestions
n=27 Participants
Participants completed 30-minute audio-recording sessions that they could initiate up to twice daily throughout the study. During audio-recording sessions, participants were randomized multiple times (every 6 minutes) to receive a notification or not, and 25% of the time the notification provided a suggestion or parenting strategy.
All participants received access to a smartphone based application that provided asynchronous behavioral parent training content.
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|---|---|---|---|
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Intervention Engagement
|
—
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—
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3.58 Number of Modules Completed
Standard Deviation 2.81
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Adverse Events
Mobile BPT With Randomized Micro-interventions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Brittany Merrill
Center for Children and Families, Florida International University, Miami, FL 33199
Phone: 305-348-6874
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place