- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05378412
Effect of the 3C Model in Students and Teachers From Vaupés, Boyacá and Amazonas
May 12, 2022 updated by: Fundación Saldarriaga Concha
Efecto Del Modelo "Conmigo, Contigo y Con Todos" (3Cs) en Niños, Niñas y Adolescentes y Sus Profesores en Vaupés, Boyacá y Amazonas
This study will evaluate the effectiveness of the "3Cs - Conmigo, Contigo y Con todo" strategy in strengthening resilience and compassion in students and teachers from three regions from Colombia: Vaupés, Amazonas and Boyacá.
It will also evaluate its relevance in the design of programs aimed at mental health in educational settings.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Colombia has experienced a long-lasting internal armed conflict that has impacted society at all levels and on people of all ages.
This has led to changes in behavior and the way people cope with psychosocial distress.
Focusing on children and adolescents, this study aims to assess the effectiveness of the "3Cs - Conmigo, Contigo y Con todo" strategy in strengthening resilience and compassion.
The changes in the scores of the CD-RISC and ECOM instruments will be evaluated through a mixed methods analysis that will evaluate the pre and post intervention results and the perception of all the actors involved in the development and implementation of the 3Cs program.
Study Type
Interventional
Enrollment (Anticipated)
6000
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Students and teachers from public institutions
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: 3Cs
|
The 3Cs program is an educational strategy aimed at fostering resilience and compassion in people.
It is based on improving the mental well-being of the participants by transforming their attitudes and behaviors through increased consciousness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CD-RISC
Time Frame: 36 months
|
CD-RISC score
|
36 months
|
|
ECOM
Time Frame: 36 months
|
ECOM score
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2023
Primary Completion (Anticipated)
December 1, 2025
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
May 12, 2022
First Submitted That Met QC Criteria
May 12, 2022
First Posted (Actual)
May 18, 2022
Study Record Updates
Last Update Posted (Actual)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 12, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 10085 (DAIDS ES)
- SIGP 92409 (Other Identifier: Ministerio de Ciencias, Tecnología e Innovación)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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