- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05955274
Mobile Behavioral Parent Training for Childhood ADHD: Pilot Trial
Personalizing Behavioral Parent Training: Improving Reach and Outcomes for Families of Children With ADHD
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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Buffalo, New York, United States, 14226
- Center for Children and Families of Western New York
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: mBPT only
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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.
|
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Experimental: mBPT and just-in-time adaptive intervention
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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.
Parents will receive prompts via phone that provide parenting suggestions and parenting feedback when they are interacting with their child.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Engagement
Time Frame: Through study completion, average of 10 weeks
|
Number of mobile BPT sessions completed divided by the total number of sessions available.
|
Through study completion, average of 10 weeks
|
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Receipt of Prompts
Time Frame: Through study completion, average of 10 weeks
|
Percent of prompts sent that were opened within 20 minutes of being sent
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Through study completion, average of 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Passive Audio Data- Positive Parenting
Time Frame: During the last 1 week of study completion
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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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34MH128513 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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