Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03846154
Recruitment Status : Active, not recruiting
First Posted : February 19, 2019
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
Vivo international e.V.
Psychologues sans Frontières Burundi
Université Lumière de Bujumbura
Information provided by (Responsible Party):
Anselm Crombach, University of Konstanz

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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : March 1, 2018
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Intervention group

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
  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

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.



Primary Outcome Measures :
  1. Change of load of traumatic symptoms measured via the University of California at Los Angeles Posttraumatic Stress Disorder Reaction Index (scale administered by Clinicians) [ Time Frame: 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

  2. Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence Checklist [ Time Frame: baseline; 5 months follow-up; 9 months follow-up ]
    32 items; answer categories: yes or no; sum score ranges from 0 - 32

  3. Change of experienced parental maltreatment measured via a shortened version of the Maltreatment and Abuse Chronology of Exposure (MACE) [ Time Frame: 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

  4. Change of number of days spent at the landfill [ Time Frame: baseline; 5 months follow-up; 9 months follow-up ]
    during the last 14 days; sum ranges from 0 - 14



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Spending days at the landfills of Bujumbura

Exclusion Criteria:

  • Psychotic symptoms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846154


Locations
Layout table for location information
Burundi
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

Layout table for additonal information
Responsible Party: Anselm Crombach, Principal investigator, University of Konstanz
ClinicalTrials.gov Identifier: NCT03846154     History of Changes
Other Study ID Numbers: UKCR18
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Post-Traumatic
Aggression
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Behavioral Symptoms