NCT05955274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

July 12, 2023

Last Update Submit

August 28, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Intervention Engagement

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

    Through study completion, average of 10 weeks

  • Receipt of Prompts

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

    Through study completion, average of 10 weeks

Secondary Outcomes (1)

  • Passive Audio Data- Positive Parenting

    During the last 1 week of study completion

Study Arms (2)

mBPT only

ACTIVE COMPARATOR
Behavioral: Mobile Behavioral Parent Training (mBPT)

mBPT and just-in-time adaptive intervention

EXPERIMENTAL
Behavioral: Mobile Behavioral Parent Training (mBPT)Behavioral: Just-in-time intervention: Parenting Strategies

Interventions

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.

mBPT and just-in-time adaptive interventionmBPT only

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

mBPT and just-in-time adaptive intervention

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • currently meets Diagnostic Statistical Manual 5 diagnostic criteria for ADHD
  • ages 7 -12
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of two groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 21, 2023

Study Start

November 1, 2024

Primary Completion

August 14, 2025

Study Completion

August 14, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Locations