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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Mobile BPT only | Other | Participants will be randomized multiple times per day to receive no push notification. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile behavioral parent training (mBPT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Throughout study completion, average of 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Engagement | Number of mobile BPT sessions completed divided by the total number of sessions available. | Through study completion, average of 5 weeks |
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Child Inclusion Criteria:
Exclusion Criteria:
Caregiver Participant Inclusion Criterion:
- 18 years old or older
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Children and Families of Western New York | Buffalo | New York | 14226 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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%). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Includes all participants that successfully onboarded in the mobile application (27 dyads with one caregiver and one child)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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%). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Proportion Positive Sentiment | Through study completion, average of 5 weeks |
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During active study participation, approximately 4 weeks.
54 total participants were enrolled (27 dyads with one caregiver and one child). Adverse events were assessed for both parent and child. Participant flow is reported on the dyad level as both participants were needed to participate.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brittany Merrill | Center for Children and Families, Florida International University, Miami, FL 33199 | 305-348-6874 | brmerril@fiu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2024 | Apr 8, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2024 | Nov 27, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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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).
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| In the moment feedback | Behavioral | In-the-moment feedback will include parenting feedback. |
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| In the moment suggestions | Behavioral | In-the-moment feedback will include suggestions for parenting strategies. |
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| Mean |
| Standard Deviation |
| Years |
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| Sex: Female, Male | 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 54 participants are separated into child participants (n = 27) and adult/caregiver participants (n = 27) | Count of Participants | Participants |
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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.
| OG001 | 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. |
| OG002 | 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. |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Proportion Negative Sentiment | Throughout study completion, average of 5 weeks |
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| Secondary | Intervention Engagement | Number of mobile BPT sessions completed divided by the total number of sessions available. | The sample size of 27 includes all caregivers who enrolled in the study and successfully downloaded the smartphone application. | Posted | Mean | Standard Deviation | Number of Modules Completed | Through study completion, average of 5 weeks |
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| 0 |
| 54 |
| 0 |
| 54 |
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| 54 |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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