Mobile Behavioral Parent Training for Childhood ADHD: A Micro-randomized Trial

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Personalizing Behavioral Parent Training: Improving Reach and Outcomes for Families of Children With Attention Deficit Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06012851
• Other study ID #: 1R34MH128513-01
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Florida International University
• Contact: Brittany Merrill, Ph.D
• Phone: 7163595773
• Email: brmerril[@]fiu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Behavioral:
• Mobile behavioral parent training (mBPT) and prompts
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 and parenting strategies.

Locations

Country	Name	City	State
United States	Center for Children and Families of Western New York	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Through study completion, average of 5 weeks
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.	Throughout study completion, average of 5 weeks
Secondary	Intervention Engagement	Number of mobile BPT sessions completed divided by the total number of sessions available.	Through study completion, average of 5 weeks