search
Back to results

Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Mental Health Symptoms

Primary Purpose

Posttraumatic Stress Disorder, Aggressive Behaviour, Parental Maltreatment

Status
Completed
Phase
Not Applicable
Locations
Burundi
Study Type
Interventional
Intervention
Comprehensive family intervention including individual sessions of FORNET
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Spending days at the landfills of Bujumbura

Exclusion Criteria:

  • Psychotic symptoms

Sites / Locations

  • vivo international & Psychologues sans Frontières mental health center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Children and adolescents in the intervention group received: 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 is provided If needed legal assistance is provided

The control group was invited to participate in three interviews getting small amounts of money (~2,5 €) as decompensation of their time.

Outcomes

Primary Outcome Measures

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
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
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
Change of number of days spent at the landfill
during the last 14 days; sum ranges from 0 - 14

Secondary Outcome Measures

Full Information

First Posted
February 15, 2019
Last Updated
April 24, 2019
Sponsor
University of Konstanz
Collaborators
Vivo international e.V., Psychologues sans Frontières Burundi, Université Lumière de Bujumbura
search

1. Study Identification

Unique Protocol Identification Number
NCT03846154
Brief Title
Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Mental Health Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
Vivo international e.V., Psychologues sans Frontières Burundi, Université Lumière de Bujumbura

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Aggressive Behaviour, Parental Maltreatment, Days Spent at the Landfill

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Children and adolescents in the intervention group received: 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 is provided If needed legal assistance is provided
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group was invited to participate in three interviews getting small amounts of money (~2,5 €) as decompensation of their time.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive family intervention including individual sessions of FORNET
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of load of traumatic symptoms measured via the University of California at Los Angeles Posttraumatic Stress Disorder Reaction Index (scale administered by Clinicians)
Description
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
Time Frame
baseline; 5 months follow-up; 9 months follow-up
Title
Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence Checklist
Description
32 items; answer categories: yes or no; sum score ranges from 0 - 32
Time Frame
baseline; 5 months follow-up; 9 months follow-up
Title
Change of experienced parental maltreatment measured via a shortened version of the Maltreatment and Abuse Chronology of Exposure (MACE)
Description
total sum score ranges from 0 - 100; sum score of each sub scale ranges from 0 - 10
Time Frame
baseline; 5 months follow-up; 9 months follow-up
Title
Change of number of days spent at the landfill
Description
during the last 14 days; sum ranges from 0 - 14
Time Frame
baseline; 5 months follow-up; 9 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Spending days at the landfills of Bujumbura Exclusion Criteria: Psychotic symptoms
Facility Information:
Facility Name
vivo international & Psychologues sans Frontières mental health center
City
Bujumbura
State/Province
Bujumbura Mairie
Country
Burundi

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently there is no plan to share IPD with other researchers not related to the institutions conducting the study. If data is shared, the PI will supervise those analysing the date, e.g., students writing their theses

Learn more about this trial

Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Mental Health Symptoms

We'll reach out to this number within 24 hrs