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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06297135
• Other study ID #: HSR-2023-020
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: Okinawa Institute of Science and Technology Graduate University
• Contact: Emi Furukawa, PhD
• Phone: +81989668814
• Email: adhd[@]oist.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Behavioral Parent Training
Teaches parents antecedent- and reinforcement-based behavior management techniques and provide support to manage their stress

Locations

Country	Name	City	State
Japan	Miyazaki International College	Miyazaki
Japan	Okinawa Institute of Science and Technology Graduate University	Onna	Okinawa

Sponsors (3)

Lead Sponsor	Collaborator
Okinawa Institute of Science and Technology Graduate University	Japan society for the promotion of science, Miyazaki International College

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Number of videos viewed	The number of videos viewed (minimum 0, maximum 6) to evaluate participant engagement.	1 month
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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