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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2019
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Comprehensive family intervention including individual sessions of FORNET
A group intervention once a week for about 20 weeks, including psychoeducation on mental health and drug abuse, anger management, roles within families, developing plans for the future, communication skills, sex education. Access to schools and school material Family visits Their parents received training regarding agriculture and microcredit projects, and financial assistance FORNET if affected by trauma-related symptoms, and/or acting aggressive If needed medical assistance /.) If needed, legal assistance

Locations

Country Name City State
Burundi vivo international & Psychologues sans Frontières mental health center Bujumbura Bujumbura Mairie

Sponsors (4)

Lead Sponsor Collaborator
University of Konstanz Psychologues sans Frontières Burundi, Université Lumière de Bujumbura, Vivo international e.V.

Country where clinical trial is conducted

Burundi, 

Outcome

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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