- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03846154
Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Mental Health Symptoms
Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Trauma-related Mental Health Symptoms
Children living at the landfills of Bujumbura are often exposed to maltreatment, including emotional neglect and physical abuse, and traumatic experiences. Furthermore, they grow up in severe poverty. Addressing trauma-related mental health issues and aggressive behaviour by Narrative Exposure Therapy (FORNET), familial communication by family visits, interaction difficulties of children by a group intervention, poverty by financial support and economic training for mothers, medical problems by medical assistance, legal conflicts by legal advice, and providing access to school, we aimed at reintegrating those children within the Burundian school system and improving familial relationships.
The investigators want to provide evidence, that mental health interventions are an integral part of assisting children and families affected by poverty and violence.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Bujumbura Mairie
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Bujumbura, Bujumbura Mairie, Burundi
- vivo international & Psychologues sans Frontières mental health center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Spending days at the landfills of Bujumbura
Exclusion Criteria:
- Psychotic symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Intervention group
Children and adolescents in the intervention group received:
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|
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NO_INTERVENTION: Control group
The control group was invited to participate in three interviews getting small amounts of money (~2,5 €) as decompensation of their time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of load of traumatic symptoms measured via the University of California at Los Angeles Posttraumatic Stress Disorder Reaction Index (scale administered by Clinicians)
Time Frame: baseline; 5 months follow-up; 9 months follow-up
|
27 items assessing PTSD, 4 additional items assessing dissociation on a scale from 0 - 4. Due to scoring rules, total sum score ranges from 0 to 80; sub scale intrusion: 0 - 20; sub scale avoidance: 0 - 8; sub scale negative cognitions: 0 - 28; sub scale hyperarousal: 0 - 24; higher values indicate more severe PTSD symptoms; all items are summed up for the total score
|
baseline; 5 months follow-up; 9 months follow-up
|
|
Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence Checklist
Time Frame: baseline; 5 months follow-up; 9 months follow-up
|
32 items; answer categories: yes or no; sum score ranges from 0 - 32
|
baseline; 5 months follow-up; 9 months follow-up
|
|
Change of experienced parental maltreatment measured via a shortened version of the Maltreatment and Abuse Chronology of Exposure (MACE)
Time Frame: baseline; 5 months follow-up; 9 months follow-up
|
total sum score ranges from 0 - 100; sum score of each sub scale ranges from 0 - 10
|
baseline; 5 months follow-up; 9 months follow-up
|
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Change of number of days spent at the landfill
Time Frame: baseline; 5 months follow-up; 9 months follow-up
|
during the last 14 days; sum ranges from 0 - 14
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baseline; 5 months follow-up; 9 months follow-up
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Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKCR18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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