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Mobile Behavioral Parent Training for Childhood ADHD: Pilot 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)

Just-in-time intervention: Parenting Strategies

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 2

Arm Type

Active Comparator

Experimental

Arm Label

mBPT only

mBPT and just-in-time adaptive intervention

Arm Description

Outcomes

Primary Outcome Measures

Intervention Engagement

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

Receipt of Prompts

Percent of prompts sent that were opened within 20 minutes of being sent

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05955274

First Posted

July 12, 2023

Last Updated

July 19, 2023

Sponsor

Florida International University

1. Study Identification

Unique Protocol Identification Number

NCT05955274

Brief Title

Mobile Behavioral Parent Training for Childhood ADHD: Pilot Trial

Official Title

Personalizing Behavioral Parent Training: Improving Reach and Outcomes for Families of Children With ADHD

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 2024 (Anticipated)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

August 2025 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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

Parallel Assignment

Model Description

Participants are randomly assigned to one of two groups

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mBPT only

Arm Type

Active Comparator

Arm Title

mBPT and just-in-time adaptive intervention

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Mobile Behavioral Parent Training (mBPT)

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.

Intervention Type

Behavioral

Intervention Name(s)

Just-in-time intervention: Parenting Strategies

Intervention Description

Parents will receive prompts via phone that provide parenting suggestions and parenting feedback when they are interacting with their child.

Primary 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 10 weeks

Title

Receipt of Prompts

Description

Percent of prompts sent that were opened within 20 minutes of being sent

Time Frame

Through study completion, average of 10 weeks

Secondary Outcome Measure Information:

Title

Passive Audio Data- Positive Parenting

Description

Parenting Behavior- Dyadic Parent Child Interaction Coding System, number of labeled praises and unlabeled praises per hour during last week of study.

Time Frame

During the last 1 week of study completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brittany Merrill, Ph.D.

Phone

716-359-5773

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

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brittany Merrill, Ph.D.

Phone

716-359-5773

brmerril@fiu.edu

12. IPD Sharing Statement

Learn more about this trial

Mobile Behavioral Parent Training for Childhood ADHD: Pilot Trial

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