NCT03846154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

1.1 years

First QC Date

February 15, 2019

Last Update Submit

April 24, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Children and adolescents in the intervention group received: 1. 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. 2. Access to schools and school material 3. Family visits 4. Their parents received training regarding agriculture and microcredit projects, and financial assistance 5. FORNET if affected by trauma-related symptoms, and/or acting aggressive 6. If needed medical assistance is provided 7. If needed legal assistance is provided

Behavioral: Comprehensive family intervention including individual sessions of FORNET

Control group

NO INTERVENTION

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

Interventions

1. 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. 2. Access to schools and school material 3. Family visits 4. Their parents received training regarding agriculture and microcredit projects, and financial assistance 5. FORNET if affected by trauma-related symptoms, and/or acting aggressive 6. If needed medical assistance /.) If needed, legal assistance

Intervention group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Spending days at the landfills of Bujumbura

You may not qualify if:

  • Psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

vivo international & Psychologues sans Frontières mental health center

Bujumbura, Bujumbura Mairie Province, Burundi

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAggression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 19, 2019

Study Start

March 1, 2018

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

April 25, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

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

Locations