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

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ClinicalTrials.gov Identifier: NCT03846154
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : April 25, 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

Tracking Information
First Submitted Date  ICMJE February 15, 2019
First Posted Date  ICMJE February 19, 2019
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE March 1, 2018
Actual Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2019)
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
  • Change of load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (PTSD scale administered by Clinicians) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: baseline; 5 months follow-up; 9 months follow-up ]
  • Change of number of days spent at the landfill [ Time Frame: baseline; 5 months follow-up; 9 months follow-up ]
Change History Complete list of historical versions of study NCT03846154 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Mental Health Symptoms
Official Title  ICMJE Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Trauma-related Mental Health Symptoms
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Posttraumatic Stress Disorder
  • Aggressive Behaviour
  • Parental Maltreatment
  • Days Spent at the Landfill
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Comprehensive family intervention including individual sessions of FORNET
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2019)
96
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2019
Actual Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Spending days at the landfills of Bujumbura

Exclusion Criteria:

  • Psychotic symptoms
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Burundi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03846154
Other Study ID Numbers  ICMJE UKCR18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Anselm Crombach, University of Konstanz
Study Sponsor  ICMJE University of Konstanz
Collaborators  ICMJE
  • Vivo international e.V.
  • Psychologues sans Frontières Burundi
  • Université Lumière de Bujumbura
Investigators  ICMJE Not Provided
PRS Account University of Konstanz
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP