Effectiveness of a Community - Based Cross-sector Network for the Management of Mental Health Problems and Disorders Associated With Forced Displacement Due to Armed Conflict in the Municipality of Soacha - Cundinamarca

NCT03839225 | Completed DMC

• 1 other identifier: Soacha 1
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

Brief Summary

It is of great importance to generate interventions that help ensure greater inclusion and social participation of the population that was and is a victim of the armed conflict, especially in the post-conflict transition in Colombia, and to influence development in the post-accord period through relationships between groups and society. Therefore, the question for this investigation is, what is the effectiveness of a community-based cross-sector network for the management of mental problems and disorders associated with forced displacement due to armed conflict in the commune of Soacha - Cundinamarca, in order to contribute to inclusion and social participation in the post-accord period? Objective: To design a community-based cross-sector network for the management of mental problems and disorders associated with forced displacement due to armed conflict in the commune of Soacha - Cundinamarca, in order to contribute to inclusion and social participation in the post-accord period in Colombia.

Conditions

Mental Disorder; Mental Disorder in Adolescence; Mental Problems; Mental Disorder in Infancy

Outcome Measures

Primary Outcomes (4)

• Change from the measure of mental disorders, including depression, anxiety-related disorders, and somatoform disorders: adolescents and adults at 1 year (after Community - Based Cross-sector Network implementation)

  Scale: the Self-Reporting Questionnaire (SRQ) which were used in the 2015 National Mental Health Survey in Colombia. SRQ consists of 20 items indicative of non-psychotic mental disorders, each of the 20 items is scored 0 or 1. A score of 1 indicates that the symptom was present during the past month, a score of o indicates that the symptom was absent.

  Before (baseline) and 1 year after Community - Based Cross-sector Network implementation

• Change from the measure of Child mental health problems (between the ages of 5 and 15) at 1 year (after Community - Based Cross-sector Network implementation)

  Scale: Reporting Questionnaire for Children (RQC) is a 10-item instrument administered verbally to the caregivers of children. It has been shown to identify moderate to severe mental retardation, significant degrees of emotional or behavioral disorder, which adversely affect schooling or socialization, and psychotic disorders among children. The instrument is scored by placing an X in any of the two response options and is scored in a simple manner, assigning one (1) point for each positive response. The presence of only an affirmative answer is indicative of the presence of a mental health problem. A single positive item was considered an appropriate cut-off for screening cases and perhaps for pointing towards a particular disorder. The RQC has 88% sensitivity in identifying cases diagnosed by a psychiatrist using a diagnostic interview according to the DSM-IV

  Before (baseline) and 1 year after Community - Based Cross-sector Network implementation

• Change from depression measure (adolescents and adults) at 1 year (after Community - Based Cross-sector Network implementation)

  Scale: The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).

  Before (baseline) and 1 year after Community - Based Cross-sector Network implementation

• Change from Posttraumatic Stress Disorder (children, adolescents and adults) at 1 year (after Community - Based Cross-sector Network implementation)

  The POSTTRAUMATIC STRESS DISORDER CHECKLIST (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including Monitoring symptom change during and after treatment, Screening individuals for PTSD, and Making a provisional PTSD diagnosis. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. A PCL-5 cut-point score is 33. The test is designed in such a way that if an item is answered, it is scored "0" and the next question is followed. Now, if he answers affirmatively, the questions that follow the item are formulated to know the frequency. Sometimes scored with "1" and sometimes with "2", the total score is 60, a fact that reflects the frequency of the symptoms

  Before (baseline) and 1 year after Community - Based Cross-sector Network implementation

Secondary Outcomes (3)

• Change from the personal factors of resilience (adolescents and adults) at 1 year (after Community - Based Cross-sector Network implementation)

  Before (baseline) and 1 year after Community - Based Cross-sector Network implementation

• Change from the measure of the problem or risky substance use in Children, adolescents, and adults at 1 year (after Community - Based Cross-sector Network implementation)

  Before (baseline) and 1 year after Community - Based Cross-sector Network implementation

• Change from the measure of Hazardous and harmful alcohol consumption (adolescents and adults) at 1 year (after Community - Based Cross-sector Network implementation)

  Before (baseline) and 1 year after Community - Based Cross-sector Network implementation

Other Outcomes (3)

• Change from the measure of Family Functioning at 1 year (after Community - Based Cross-sector Network implementation)

  Before (baseline) and 1 year after Community - Based Cross-sector Network implementation

• Change from the measure of Eating Attitudes (adolescents and adults) at 1 year (after Community - Based Cross-sector Network implementation)

  Before (baseline) and 1 year after Community - Based Cross-sector Network implementation

• Change from the measure of Bullying (ages between 10 and 18 years) at 1 year (after Community - Based Cross-sector Network implementation)

  Before (baseline) and 1 year after Community - Based Cross-sector Network implementation

Study Arms (1)

Children, Adolescents and Adults

OTHER

children, adolescents and adults who have been victims of the armed conflict in the municipalities of Soacha-Cundimanarca (Colombia)

Other: Community intervention

Interventions

Community intervention OTHER

Community intervention will be built depending on contextual factors and will contain the following elements: * Cross-sector intervention, including sectors to define the intervention as "primary health care services, education services" (language, knowledge to prevent health problems and resilience strategies), family welfare units, "Integral Care and Reparation Unit for Victims" (UARIV), Ministry of Labour, national and international social support network, among others. * The leader will be chosen by the community, with the capabilities to coordinate the community-based network. * Mental health providers at the local level, who must develop psychosocial and mental diagnoses and interventions, based on experience and evidence, respectively. This team will include psychiatry, psychologists (one an expert in clinical psychology) and a community team involved in the implementation of mental interventions.

Children, Adolescents and Adults

Eligibility Criteria

• Age: 7 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children (7 to 11 years old), adolescents (12 to 18 years old) and adults (\>18 years old) who have been victims of the armed conflict in the municipalities of Soacha - Cundinamarca, occurring during the last 5 years prior to the start of the project

You may not qualify if:

• People with neurocognitive disorders

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead
• The University of Bath in England: collaborator
• Sociedad Colombiana de Anestesiología y Reanimación: collaborator

Study Sites (1)

Facultad de Medicina, Universidad Nacional de Colombia

Bogotá, Colombia

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A mixed study of before and after using quantitative and qualitative research techniques

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: February 15, 2019
• Study Start: November 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: July 1, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

CO (1)