- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06012851
Mobile Behavioral Parent Training for Childhood ADHD: A Micro-randomized Trial
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?
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New York
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Buffalo, New York, United States, 14226
- Center for Children and Families of Western New York
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Child Inclusion Criteria:
- Currently meets Diagnostic Statistical Manual 5 diagnostic criteria for ADHD
- Ages 7 -12
- Has parent-reported impairment in homework performance defined as a score of 3 or greater on an Impairment Rating Scale measure (Fabiano et al., 2006) of homework performance
- Has at least one parent or primary caregiver who is willing to participate and is able to access the intervention at home via smartphone.
Exclusion Criteria:
- N/A
Caregiver Participant Inclusion Criterion:
- 18 years old or older
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile BPT with in-the-moment feedback
Participants will be randomized multiple times per day to receive a push notification that provides feedback about parenting.
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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 feedback will include parenting feedback.
|
|
Experimental: Mobile BPT with in-the-moment suggestions
Participants will be randomized multiple times per day to receive a push notification that provides a suggestion for a parenting behavior.
|
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 feedback will include suggestions for parenting strategies.
|
|
Other: Mobile BPT only
Participants will be randomized multiple times per day to receive no push notification.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion, average of 5 weeks
|
|
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.
|
Throughout study completion, average of 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Engagement
Time Frame: Through study completion, average of 5 weeks
|
Number of mobile BPT sessions completed divided by the total number of sessions available.
|
Through study completion, average of 5 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34MH128513-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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