- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06750510
Digital Universal Parenting Program for Positive Parenting Behaviors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will use a single-arm study design.The participants will use the universal parenting program for 8-weeks.
The intervention is a digital parent training program which focuses on positive parenting and encouraging to develop parenting skills that strengthen the relationships and communication with their children. The topics includes for example reinforcing child´s positive behavior, reducing conflict situations and planning situations advanced, managing daily transitions, and being present to child. The program includes 5 themes with recommended length of 1 week each. Each theme includes theory material, videos, examples, video practices and exercises. The program is fully digital and provided in a dynamic, web-based format. SMS and email reminders will be sent regularly during the program.
Recruitment: All parents with a 3-year old child who is participating in annual health checkup in child health clinic are considered eligible to the study and are asked to participate if they fulfil inclusion criteria and do not meet the exclusion criteria.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kaisa Mishina, PhD
- Phone Number: 358503101358
- Email: kaemka@utu.fi
Study Locations
-
-
-
Turku, Finland
- Recruiting
- Kaisa Mishina
-
Contact:
- Kaisa Mishina
-
Turku, Finland
- Recruiting
- Wellbeing service counties
-
Contact:
- Kaisa Mishina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Guardians having a child aged 3 years participating to annual health checkup in child health clinic.
- At least one of the guardians is able to understand the languages that intervention is provided in
Exclusion Criteria:
- Inability to read Finnish, Swedish, or English, as these are the languages that the intervention is provided in.
- No internet access
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants assigned to this condition will receive the 8-weeks intervention
|
The intervention is a universal, digitally delivered parenting program, including 5 themes with recommended length of 1 week each.
The total length of the intervention is 8 weeks.
The program focuses on positive parenting, encouraging to develop parenting skills that strengthen their relationships and communication with their children.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child´s affective reactivity
Time Frame: From baseline to 8-weeks follow-up
|
The Affective Reactivity Index (ARI-P)
|
From baseline to 8-weeks follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behaviour of the child
Time Frame: From baseline to 8-weeks follow-up
|
10 questions about child´s behavior, focusing especially for child´s hyperactivity and conduct problems.
|
From baseline to 8-weeks follow-up
|
|
Daily activities
Time Frame: From baseline up to 8-weeks
|
A questionnaire adapted from the Barkley Home Situations Questionnaire, which asks the parent to rate whether the child's behavior causes problems during specified daily routines
|
From baseline up to 8-weeks
|
|
Completion rates
Time Frame: From baseline up to 8-weeks
|
Completion and non-completion of the intervention for eight-week period by using the data recorded of the intervention platform
|
From baseline up to 8-weeks
|
|
Intervention satisfaction
Time Frame: 8-weeks follow-up
|
Questions related to satisfaction toward the intervention and acknowledged support in specific areas of parenting provided in the intervention
|
8-weeks follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Andre Sourander, Professor, MD, University of Turku
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BePresent
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
product manufactured in and exported from the U.S.
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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