A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits

Loving Habits: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits

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.

Study Overview

• Status: Recruiting
• Conditions: ADHD
• Intervention / Treatment: Behavioral: Behavioral Parent Training

Detailed Description

This pilot study employs a pre-post, open trial design with the primary aim to investigate the feasibility of delivering parenting educational materials in an accessible format, i.e., a widely used testing platform. The training videos demonstrate the applications of antecedent- and reinforcement-based behavior management techniques in a specific situation and encourage parents to build positive parenting habits. The program usability and satisfaction will be assessed through participant ratings. The study targets parents of children demonstrating inattention, hyperactive, and impulsive behavior. These families frequently experience difficulties managing everyday routines at home, yet the access to psychosocial treatment is limited. The investigators expect parents to engage well in the program delivered via digital media. Based on the existing literature on the effectiveness of behavior parent training delivered in traditional in-person format, a moderate effect size is expected in the pre-post measures of parenting practices and the child target behavior for this study.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emi Furukawa, PhD; Phone Number: +81989668814; Email: adhd@oist.jp

Study Locations

• Japan
  • Miyazaki, Japan, 889-1605
    • Recruiting
    • Miyazaki International College
    • Contact: Aya Kasai, PhD; Phone Number: +81985855931; Email: akasai@sky.miyazaki-mic.ac.jp
    • Principal Investigator: Aya Kasai, PhD
  • Okinawa
    • Onna, Okinawa, Japan, 904-0495
      • Recruiting
      • Okinawa Institute of Science and Technology Graduate University
      • Contact: Emi Furukawa, PhD; Phone Number: +81989668814; Email: adhd@oist.jp
      • Principal Investigator: Emi Furukawa, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral intervention group; 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; Teaches parents antecedent- and reinforcement-based behavior management techniques and provide support to manage their stress

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent-rated child's difficulties with daily transitions	The parent-rated child's difficulties with 9 common daily transitions. Ratings completed before and after the intervention using a 3-point scale. Averaged across the ratings completed for the 9 transitions. Higher scores indicate greater difficulties.	1 month
Parent-rated child's impairment related to transition difficulties	The parent-rated level of impairment caused by transition difficulties (1 item). Ratings completed before and after the intervention using a 7 point scale. Higher scores indicate greater impairment.	1 month
Positive parenting	Positive and Negative Parenting Scale (PNPS) Positive Parenting sub-scale. Parent ratings completed before and after the intervention using a 4-point scale. Average across 8 items. Higher scores indicate more frequent use of positive parenting strategies.	1 month
Negative parenting	Positive and Negative Parenting Scale (PNPS) Negative Parenting sub-scale. Parent ratings completed before and after the intervention using a 4-point scale. Average across 8 items. Higher scores indicate more frequent use of negative parenting strategies.	1 month
Parenting stress	Parent Stress Scale total score. Parent ratings completed before and after the intervention using a 5-point scale. Average across 18 items. Higher scores indicate higher levels of parent stress.	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD symptoms	SNAP-IV inattention and hyperactivity/impulsivity symptoms total. Parent ratings completed before and after the intervention using a 4-point scale. Averaged across 18 items. Higher scores indicate ADHD symptoms more frequently observed.	1 month
ODD symptoms	SNAP-IV oppositional/defiant symptoms total. Parent ratings completed before and after the intervention using a 4-point scale. Averaged across 8 items. Higher scores indicate ADHD symptoms more frequently observed.	1 month

Collaborators and Investigators

• Sponsor: Okinawa Institute of Science and Technology Graduate University
• Collaborators: Japan society for the promotion of science; Miyazaki International College

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HSR-2023-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No