NCT06297135

Brief Summary

This study evaluates the feasibility and preliminary impacts of a new parent support program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content is focused on teaching parents strategies to better manage one of the commonly reported challenges children face, a transition to a non-preferred activity. Parents with children demonstrating inattentive, hyperactive and impulsive behavior and experiencing difficulties with daily transition routines are invited to participate in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

February 1, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 29, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

1.2 years

First QC Date

February 29, 2024

Last Update Submit

December 8, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of videos viewed

    The number of videos viewed (minimum 0, maximum 6) to evaluate participant engagement.

    1 month

  • Percentage of completed daily ratings

    The percentage of completed daily ratings (minimum 0, maximum 100). Parents are asked to provide daily ratings on the degree of success in implementing parenting strategies taught.

    1 month

  • Participant satisfaction

    The parent-rated satisfaction regarding information presented in the videos. A rating completed after each video viewing using a 4-point scale. Averaged across the ratings completed for the videos viewed. (Minimum 0, maximum 4). Higher scores indicate greater satisfaction.

    1 month

Secondary Outcomes (5)

  • Parent-rated child's difficulties with daily transitions

    1 month

  • Parent-rated child's impairment related to transition difficulties

    1 month

  • Positive parenting

    1 month

  • Negative parenting

    1 month

  • Parenting stress

    1 month

Other Outcomes (2)

  • ADHD symptoms

    1 month

  • ODD symptoms

    1 month

Study Arms (1)

Behavioral intervention group

EXPERIMENTAL

Parents who enroll in the program will receive a series of 6 videos (\~7 minutes each), 1 video at a time, generally every 3 days. Parents will also receive daily written texts, which include implementation tips and an assessment of a target (transition) behavior.

Behavioral: Behavioral Parent Training

Interventions

Teaches parents antecedent- and reinforcement-based behavior management techniques and provide support to manage their stress

Behavioral intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents with children aged 4-10, who experience difficulties with transitions. The program will be advertised that it was developed targeting children demonstrating behaviors consistent with ADHD, and the ADHD symptoms will be measured pre-post. However, children are not required to have a diagnosis of ADHD or show elevated levels of ADHD symptoms for the parents to sign up.

You may not qualify if:

  • Parents who do not understand Japanese (the language the program is offered in).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Miyazaki International College

Miyazaki, Miyazaki, 889-1605, Japan

Location

Okinawa Institute of Science and Technology Graduate University

Onna, Okinawa, 904-0495, Japan

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 7, 2024

Study Start

February 1, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations