Posttraumatic Stress Disorder Clinical Trial
Official title:
Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Trauma-related Mental Health Symptoms
NCT number | NCT03846154 |
Other study ID # | UKCR18 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | March 30, 2019 |
Verified date | April 2019 |
Source | University of Konstanz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 96 |
Est. completion date | March 30, 2019 |
Est. primary completion date | March 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Spending days at the landfills of Bujumbura Exclusion Criteria: - Psychotic symptoms |
Country | Name | City | State |
---|---|---|---|
Burundi | vivo international & Psychologues sans Frontières mental health center | Bujumbura | Bujumbura Mairie |
Lead Sponsor | Collaborator |
---|---|
University of Konstanz | Psychologues sans Frontières Burundi, Université Lumière de Bujumbura, Vivo international e.V. |
Burundi,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of load of traumatic symptoms measured via the University of California at Los Angeles Posttraumatic Stress Disorder Reaction Index (scale administered by Clinicians) | 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 | |
Primary | Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence Checklist | 32 items; answer categories: yes or no; sum score ranges from 0 - 32 | baseline; 5 months follow-up; 9 months follow-up | |
Primary | Change of experienced parental maltreatment measured via a shortened version of the Maltreatment and Abuse Chronology of Exposure (MACE) | 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 | |
Primary | Change of number of days spent at the landfill | during the last 14 days; sum ranges from 0 - 14 | baseline; 5 months follow-up; 9 months follow-up |
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