Mental DisorderNCT03839225
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
A study testing Community intervention in people with Mental Disorder and Mental Disorder in Adolescence, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Mental Disorder in Adolescence, Mental Problems
- What is being tested?
- Community intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteColombia
- Study dates
- 1 Nov 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- People with neurocognitive disorders
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Community intervention
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Children, Adolescents and Adults | Other | children, adolescents and adults who have been victims of the armed conflict in the municipalities of Soacha-Cundimanarca (Colombia) Receives: Other: Community intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: 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
Measured: 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)
Personal factors of resilience Scale (FPR-1) was developed to analyze the personal factors of resilience in a group of 113 women displaced by violence in Colombia.
377/5000 It is a Likert scale, with three response options: in disagreement (1), neither agree nor disagree (2) and agree (3). Scores between 1 and 1.5 are considered a low level; scores between 1.6 and 2 are considered medium-low; scores between 2.1 and 2.5 medium-high; Scores between 2.6 and 3 indicate a high level for global resilience or for the specific dimension.
Measured: 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)
Scale: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was developed for the World Health Organization (WHO) by an international group of substance abuse researchers to detect and manage substance use and related problems in primary and general medical care settings.
A risk score is provided for each substance, and scores are grouped into low, moderate or high risk.
Low risk: scores of 'three or less' ('10 or less' for alcohol) of presenting problems related to substance use Moderate risk: score between 4 and 26 '('11 and 26' for alcohol), although they may present some problems, they have a moderate risk of presenting health and other problems.
High risk: score of '27 or more 'in any substance suggests that the user has a high risk of dependence on that substance and is probably having health, social, economic, legal and personal relationship problems as a result of the consumption of substances.
Measured: 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)
Scale: The Alcohol Use Disorders Identification Test (AUDIT) is a very reliable and simple screening tool which is sensitive to early detection of risky and high risk (or hazardous and harmful) drinking. It has three questions on alcohol consumption (1 to 3), three questions on drinking behaviour and dependence (4 to 6) and four questions on the consequences or problems related to drinking (7 to 10).
Scores for each question range from 0 to 4, with the first response for each question (eg never) scoring 0, the second (eg less than monthly) scoring 1, the third (eg monthly) scoring 2, the fourth (eg weekly) scoring 3, and the last response (eg. daily or almost daily) scoring 4. For questions 9 and 10, which only have three responses, the scoring is 0, 2 and 4 (from left to right). A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.
Measured: Before (baseline) and 1 year after Community - Based Cross-sector Network implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Nov 2018
- Primary completion1 Sep 2019
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A mixed study of before and after using quantitative and qualitative research techniques
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Bath in England, Sociedad Colombiana de Anestesiología y Reanimación
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839225
- Sponsor's protocol ID
- Soacha 1
- Status last verified
- Apr 2021
- First submitted
- 22 Nov 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03839225
- Acronym / sponsor ID
- Soacha 1
- Conditions
- Mental Disorder, Mental Disorder in Adolescence, Mental Problems, Mental Disorder in Infancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Collaborators
- The University of Bath in England, Sociedad Colombiana de Anestesiología y Reanimación
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A mixed study of before and after using quantitative and qualitative research techniques
| Arm | Type | Receives |
|---|---|---|
| Children, Adolescents and Adults | Other | Other: Community interventionchildren, adolescents and adults who have been victims of the armed conflict in the municipalities of Soacha-Cundimanarca (Colombia) |
Who may qualify
- Ages
- 7 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- People with neurocognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community interventionCommunity 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. | Other | Children, Adolescents and Adults |
Primary outcome
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)
Time frame: Before (baseline) and 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.
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)
Time frame: Before (baseline) and 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
Change from depression measure (adolescents and adults) at 1 year (after Community - Based Cross-sector Network implementation)
Time frame: Before (baseline) and 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).
Change from Posttraumatic Stress Disorder (children, adolescents and adults) at 1 year (after Community - Based Cross-sector Network implementation)
Time frame: Before (baseline) and 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
3 secondary outcomes
Change from the personal factors of resilience (adolescents and adults) at 1 year (after Community - Based Cross-sector Network implementation)
Time frame: 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)
Time frame: 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)
Time frame: Before (baseline) and 1 year after Community - Based Cross-sector Network implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community intervention in people with Mental Disorder and Mental Disorder in Adolescence, run by Universidad Nacional de Colombia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Before (baseline) and 1 year after Community - Based Cross-sector Network implementation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.