Mobile Behavioral Parent Training for Childhood ADHD: Pilot Trial

Sponsor
Florida International University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05955274
Collaborator
(none)
50
1
2
12
4.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mobile Behavioral Parent Training (mBPT)
  • Behavioral: Just-in-time intervention: Parenting Strategies
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomly assigned to one of two groupsParticipants are randomly assigned to one of two groups
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Personalizing Behavioral Parent Training: Improving Reach and Outcomes for Families of Children With ADHD
Anticipated Study Start Date :
Aug 1, 2024
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: mBPT only

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.

Experimental: mBPT and just-in-time adaptive 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Intervention Engagement [Through study completion, average of 10 weeks]

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

  2. Receipt of Prompts [Through study completion, average of 10 weeks]

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

Secondary Outcome Measures

  1. Passive Audio Data- Positive Parenting [During the last 1 week of study completion]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Children and Families of Western New York Buffalo New York United States 14226

Sponsors and Collaborators

  • Florida International University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Florida International University
ClinicalTrials.gov Identifier:
NCT05955274
Other Study ID Numbers:
  • 1R34MH128513
First Posted:
Jul 21, 2023
Last Update Posted:
Jul 21, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2023