Effect of the 3C Model in Students and Teachers From Vaup... | NCT05378412

Studies
Effect of the 3C Model in Students and Teachers From Vaupés, Boyacá and Amazonas

NCT05378412

Sponsor

Fundación Saldarriaga Concha

Status

Unknown status

Last Update Posted

May 18, 2022Actual

Enrollment

6,000Estimated

Phase

Not Applicable

Conditions

Resilience, Compassion

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SIGP 92409	Other Identifier	Ministerio de Ciencias, Tecnología e Innovación

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2023Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

May 12, 2022

First Submission Date that Met QC Criteria

May 12, 2022

First Posted Date

May 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2022

Last Update Posted Date

May 18, 2022Actual

Name	Class
Pontificia Universidad Javeriana	OTHER
Ministerio de Ciencia, Tecnología e Innovación	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3Cs	Experimental		Behavioral: 3Cs
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3Cs	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CD-RISC	CD-RISC score	36 months
ECOM	ECOM score	36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Students and teachers from public institutions

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided