NCT06750510

Brief Summary

The goal of this study is to evaluate use and feasibility of digitally-delivered universal parenting program, which aims to promote positive parenting among guardians with 3 years-old children.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress73%
Jan 2022Dec 2027

Study Start

First participant enrolled

January 1, 2022

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

December 27, 2024

Status Verified

August 1, 2024

Enrollment Period

4 years

First QC Date

August 29, 2024

Last Update Submit

December 19, 2024

Conditions

Parenting

Keywords

Parent-TrainingParenting

Outcome Measures

Primary Outcomes (1)

  • Child´s affective reactivity

    The Affective Reactivity Index (ARI-P)

    From baseline to 8-weeks follow-up

Secondary Outcomes (4)

  • Behaviour of the child

    From baseline to 8-weeks follow-up

  • Daily activities

    From baseline up to 8-weeks

  • Completion rates

    From baseline up to 8-weeks

  • Intervention satisfaction

    8-weeks follow-up

Study Arms (1)

Intervention

EXPERIMENTAL

Participants assigned to this condition will receive the 8-weeks intervention

Behavioral: Digitally Delivered Parent Training

Interventions

Digitally Delivered Parent TrainingBEHAVIORAL

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.

Intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Inability to read Finnish, Swedish, or English, as these are the languages that the intervention is provided in.
  • No internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaisa Mishina

Turku, Finland

RECRUITING

Wellbeing service counties

Turku, Finland

RECRUITING

Study Officials

  • Andre Sourander, Professor, MD

    University of Turku

    STUDY DIRECTOR

Central Study Contacts

Kaisa Mishina, PhD

CONTACT

358503101358kaemka@utu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 29, 2024

First Posted

December 27, 2024

Study Start

January 1, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

December 27, 2024

Record last verified: 2024-08

Locations

FI(2)