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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05955274
Other study ID # 1R34MH128513
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2024
Est. completion date August 2025

Study information

Verified date July 2023
Source Florida International University
Contact Brittany Merrill, Ph.D.
Phone 716-359-5773
Email brmerril@fiu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of the study is to develop and pilot a personalized behavioral parent training intervention for caregivers of children with attention deficit hyperactivity disorder. 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 main questions to answer are: Is parenting feedback provided by a smartphone application acceptable to caregivers? Is the phone application usable and acceptable to parents and caregivers of children with attention deficit hyperactivity disorder? In the pilot trial, participants (parents/caregivers) will be randomly assigned to either (1) use the positive parenting intervention phone application (mobile Behavioral Parent Training: mBPT) or (2) use mBPT and receive brief, personalized phone prompts throughout their participation that target parenting behavior and intervention engagement.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date August 2025
Est. primary completion date July 2025
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

Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder

Intervention

Behavioral:
Mobile Behavioral Parent Training (mBPT)
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.
Just-in-time intervention: Parenting Strategies
Parents will receive prompts via phone that provide parenting suggestions and parenting feedback when they are interacting with their child.

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 Intervention Engagement Number of mobile BPT sessions completed divided by the total number of sessions available. Through study completion, average of 10 weeks
Primary Receipt of Prompts Percent of prompts sent that were opened within 20 minutes of being sent Through study completion, average of 10 weeks
Secondary Passive Audio Data- Positive Parenting Parenting Behavior- Dyadic Parent Child Interaction Coding System, number of labeled praises and unlabeled praises per hour during last week of study. During the last 1 week of study completion
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