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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile behavioral parent training (mBPT) and prompts
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Children and Families of Western New York

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile BPT with in-the-moment feedback

Arm Description

Participants will be randomized multiple times per day to receive either a push notification related to parenting behavior or no push notification.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Intervention Engagement
Number of mobile BPT sessions completed divided by the total number of sessions available.

Full Information

First Posted
August 22, 2023
Last Updated
August 28, 2023
Sponsor
Florida International University
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1. Study Identification

Unique Protocol Identification Number
NCT06012851
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile BPT with in-the-moment feedback
Arm Type
Experimental
Arm Description
Participants will be randomized multiple times per day to receive either a push notification related to parenting behavior or no push notification.
Intervention Type
Behavioral
Intervention Name(s)
Mobile behavioral parent training (mBPT) and prompts
Intervention Description
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.
Primary Outcome Measure Information:
Title
Passive Audio Data-Positive Sentiment Analysis
Description
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.
Time Frame
Through study completion, average of 5 weeks
Title
Passive Audio Data-Negative Sentiment Analysis
Description
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.
Time Frame
Throughout study completion, average of 5 weeks
Secondary Outcome Measure Information:
Title
Intervention Engagement
Description
Number of mobile BPT sessions completed divided by the total number of sessions available.
Time Frame
Through study completion, average of 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany Merrill, Ph.D
Phone
7163595773
Email
brmerril@fiu.edu
Facility Information:
Facility Name
Center for Children and Families of Western New York
City
Buffalo
State/Province
New York
ZIP/Postal Code
14226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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