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

NCT06012851 | Completed Results

• 1 other identifier: 1R34MH128513-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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?

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Intervention Engagement

  Through study completion, average of 5 weeks

Study Arms (3)

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.

Behavioral: Mobile behavioral parent training (mBPT); Behavioral: In the moment feedback

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.

Behavioral: Mobile behavioral parent training (mBPT); Behavioral: In the moment suggestions

Mobile BPT only

OTHER

Participants will be randomized multiple times per day to receive no push notification.

Behavioral: Mobile behavioral parent training (mBPT)

Interventions

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.

Mobile BPT only; Mobile BPT with in-the-moment feedback; Mobile BPT with in-the-moment suggestions

In the moment feedback BEHAVIORAL

In-the-moment feedback will include parenting feedback.

Mobile BPT with in-the-moment feedback

In the moment suggestions BEHAVIORAL

In-the-moment feedback will include suggestions for parenting strategies.

Mobile BPT with in-the-moment suggestions

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• N/A
• \- 18 years old or older

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Center for Children and Families of Western New York

Buffalo, New York, 14226, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Brittany Merrill
• Organization: Center for Children and Families, Florida International University, Miami, FL 33199

brmerril@fiu.edu

305-348-6874

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: April 1, 2024
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2024-12

Locations

US (1)