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

Sponsor

University of Konstanz (Other)

Overall Status

Completed

CT.gov ID

NCT03846154

Collaborator

Vivo international e.V. (Industry), Psychologues sans Frontières Burundi (Other), Université Lumière de Bujumbura (Other)

Enrollment

Location

Arms

12.9

Actual Duration (Months)

7.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder Aggressive Behaviour Parental Maltreatment Days Spent at the Landfill	Behavioral: Comprehensive family intervention including individual sessions of FORNET	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Mar 30, 2019

Actual Study Completion Date :

Mar 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group 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	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
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.

Arm

Intervention/Treatment

Experimental: Intervention group

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

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

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.

Outcome Measures

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) [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
Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence Checklist [baseline; 5 months follow-up; 9 months follow-up]
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) [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
Change of number of days spent at the landfill [baseline; 5 months follow-up; 9 months follow-up]
during the last 14 days; sum ranges from 0 - 14

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Spending days at the landfills of Bujumbura

Exclusion Criteria:

Psychotic symptoms

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	vivo international & Psychologues sans Frontières mental health center	Bujumbura	Bujumbura Mairie	Burundi

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anselm Crombach, Principal investigator, University of Konstanz

ClinicalTrials.gov Identifier:

NCT03846154

Other Study ID Numbers:

UKCR18

First Posted:

Feb 19, 2019

Last Update Posted:

Apr 25, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic

Aggression

Study Results

No Results Posted as of Apr 25, 2019