- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06037642
All Children in Focus (ABC) 0-2 Years: A Pilot Study
The goal of this clinical trial is to compare parents tools to handle challenges and strengths as parents. The main questions it aims to answer are:
- Do participating parents feel more confident than non partipating parents?
- Does the program have positive effects on parenting practices, parents´ well-being, and social support?
- Is the programme more effective for some groups of parents ( e.g., gender, socioeconomis status)
Participating parents will attend four 1-hour, manual based sessions followed by a 30-minutes optional coffe break. In addition parents will be asked to do homework assignments between the sessions.
Researchers will compare the intervention group with an equally sized control group that will receive the program later the same year.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden
- PLUS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Parents to children aged 0-2 years
Exclusion Criteria:
Non fluent in Swedish language
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
|
Four 1 hour meetings and homework
|
Active Comparator: Control group
|
Will be put on hold for four weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parents´self efficacy
Time Frame: Four weeks
|
Questionnaire
|
Four weeks
|
Parenting practices and parent child relationship
Time Frame: Four weeks
|
Questionnaire
|
Four weeks
|
Parents´involvement and warmth
Time Frame: Four weeks
|
Questionnaire
|
Four weeks
|
Parents´ well-being
Time Frame: Four weeks
|
Questionnaire
|
Four weeks
|
Parents´ social network
Time Frame: Four weeks
|
Questionnaire
|
Four weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maria Eriksson, Phd, Ersta Sköndal University College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- All children in focus
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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