Clinical trial NCT06012851: Mobile Behavioral Parent Training for Childhood ADHD: A Micro-randomized Trial
Official title: Personalizing Behavioral Parent Training: Improving Reach and Outcomes for Families of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 34
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: TREATMENT

Brief 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). 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?


Eligibility criteria: 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

Primary outcomes:
measure: Passive Audio Data-Positive Sentiment Analysis
timeFrame: Through study completion, average of 5 weeks
measure: Passive Audio Data-Negative Sentiment Analysis
timeFrame: Throughout study completion, average of 5 weeks
Secondary outcomes:
measure: Intervention Engagement
timeFrame: Through study completion, average of 5 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Center for Children and Families of Western New York
state: New York
Study officials:
References: