NCT04061954

Brief Summary

Children living in poverty often are at risk to leave their family to work at the landfill. The main reasons for this are torn family systems, family violence, exclusion, poverty and a lack of intra-familial communication. Children in the district of Buterere who spend their days on the streets or on the landfills of Bujumbura, Burundi to earn a living are particularly vulnerable. The project aims to create a safe environment for these young people and to strengthen their family structures in the long term. For this purpose, we plan to treat traumatized parents psychotherapeutically and to improve their parenting skills within the families in group and family sessions. The financial situation is to be improved in the medium term through agricultural group projects. In addition, participating children and youths will be granted access to school and education, and participate in a skill training group to improve social competencies. In the long term, parents are to set up savings and micro credit groups in order to ensure the education of the children. The project involves 40 families, which are particularly affected by poverty and traumatic experiences. The project is based on scientific findings of the implementing organizations, which carried out similar projects in Burundi in the last years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

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

April 6, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2020

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

August 17, 2019

Last Update Submit

October 29, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • In parents: Change of load of traumatic symptoms measured via the PTSD Symptom Scale Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

    20 items assessing PTSD ranging from 0 - 4. 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

    baseline; 5 months follow-up; 9 months follow-up

  • In parents: Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence

    32 items; answer categories: yes or no; sum score ranges from 0 - 32

    baseline; 5 months follow-up; 9 months follow-up

  • In children: Change in experienced parental rejection measured via the short version of the Parental Acceptance Rejection Questionnaire

    24 items; answer categories: 1 - 4; sum score ranges from 24 - 96; the higher the more rejection

    baseline; 5 months follow-up; 9 months follow-up

  • In children: 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

  • In children: 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

Families in the intervention group received: 1. Parents participate in a group intervention once a week for about 20 weeks, including psychoeducation on mental health and drug and alcohol abuse, anger management, family planning, parenting skills, communication skills, and dealing with couples conflicts 2. Family visits to address topics as family cohesion, intra-familial communication and psychological basic need of children 3. Trauma-focused therapies 4. Parents receive training regarding agriculture and micro credit projects, and financial assistance 5. One child per family receives a social skill training group preparing them for returning to school 6. Access to schools and school material 7. If needed medical assistance is provided 8. If needed legal assistance is provided

Behavioral: Comprehensive family intervention including individual sessions of FORNET

No intervention 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

Families in the intervention group received: 1. Parents participate in a group intervention once a week for about 20 weeks, including psychoeducation on mental health and drug and alcohol abuse, anger management, family planning, parenting skills, communication skills, and dealing with couples conflicts 2. Family visits to address topics as family cohesion, intra-familial communication and psychological basic need of children 3. Trauma-focused therapies (FORNET), which aim also at reducing violent behaviour 4. Parents receive training regarding agriculture and micro credit projects, and financial assistance 5. One child per family receives a social skill training group preparing them for returning to school 6. Access to schools and school material 7. If needed medical assistance is provided 8. If needed legal assistance is provided

Intervention group

Eligibility Criteria

Age7 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parents who reported in a preliminary assessment to experience/or having experienced at least 3 of the following 5 conditions: (1) marital conflicts (2) difficulties to sleep in the past 4 weeks (3) Nightmares in the past 4 weeks (4) current social withdrawal (5) lost a loved one during the past year
  • Parents who spend time at the landfill
  • Parents with children between 7 and 16 who spend time at the landfill

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

August 17, 2019

First Posted

August 20, 2019

Study Start

April 6, 2019

Primary Completion

May 27, 2020

Study Completion

May 27, 2020

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Currently there is no plan to share individual participant data with other researchers not related to the institutions conducting the study. If data is shared, the PI will supervise those analyzing the data, e.g., students writing their theses.

Locations