- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07291453
Loving Habits: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emi Furukawa, PhD
- Phone Number: +81989668814
- Email: lovinghabits@oist.jp
Study Locations
-
-
Okinawa
-
Onna, Okinawa, Japan, 904-0495
- Recruiting
- Okinawa Institute of Science and Technology Graduate University
-
Principal Investigator:
- Emi Furukawa, PhD
-
Contact:
- Emi Furukawa, PhD
- Phone Number: +81989668814
- Email: lovinghabits@oist.jp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parents with children aged 4-10 who experience difficulties in situations targeted by the program.
*Note: 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 mothers 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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Following-through module
Parents will receive information about strategies during situations requiring following through on/completing tasks
|
Teaches parents antecedent- and reinforcement-based behavior management techniques and provide support to manage their stress
|
|
Experimental: Waiting module
Parents will receive information about strategies during situations requiring waiting
|
Teaches parents antecedent- and reinforcement-based behavior management techniques and provide support to manage their stress
|
|
Experimental: Overcoming challenges module
Parents will receive information about strategies during situations where a child finds it challenging to engage in tasks/behaviors, due to the the difficulty level or past failure
|
Teaches parents antecedent- and reinforcement-based behavior management techniques and provide support to manage their stress
|
|
Experimental: Transition module 1
Parents will receive information about strategies during situations where a child transitions from a preferred activity to a non-preferred activity over six videos.
|
Teaches parents antecedent- and reinforcement-based behavior management techniques and provide support to manage their stress
|
|
Experimental: Transition module 2
Parents will receive information about strategies during situations where a child transitions from a preferred activity to a non-preferred activity over two videos.
|
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
Time Frame: 1 month
|
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
Time Frame: 1 month
|
The number of videos viewed (minimum 0, maximum 6) to evaluate participant engagement.
|
1 month
|
|
Percentage of completed daily ratings
Time Frame: 1 month
|
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 in target situations
Time Frame: 1 month
|
The parent-rated child's difficulties with daily target situation examples.
Ratings completed before and after the intervention using a 4-point scale.
Averaged across the ratings completed for the 7-9 situations (varies depending on the module).
Higher scores indicate greater difficulties.
|
1 month
|
|
Parent-rated child's impairment related to target situations
Time Frame: 1 month
|
The parent-rated level of impairment caused by transition difficulties (1 item).
Ratings completed before and after the intervention using a 10 point scale.
Lower scores indicate greater impairment.
|
1 month
|
|
Positive parenting
Time Frame: 1 month
|
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 4 items.
Higher scores indicate more frequent use of positive parenting strategies.
|
1 month
|
|
Negative parenting
Time Frame: 1 month
|
Description: 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 4 items.
Higher scores indicate more frequent use of negative parenting strategies.
|
1 month
|
|
Parenting stress
Time Frame: 1 month
|
Parent Stress Scale total score.
Parent ratings completed before and after the intervention using a 5-point scale.
Average across 10 items.
Higher scores indicate higher levels of parent stress.
|
1 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ADHD symptoms
Time Frame: 1 month
|
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
Time Frame: 1 month
|
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSR-2025-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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