ClinicalTrials.gg
CompletedNCT04061954Updated Nov 1, 2021

Umuryango Ukomera Uri Hamwe - Families Are Strong Together

An interventional study of Comprehensive family intervention including individual sessions of FORNET in Posttraumatic Stress Disorder, Aggressive Behaviour and Parental Maltreatment, sponsored by University of Konstanz. Completed at 1 site in Burundi. Open to participants aged 7 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-01.

Sponsored by University of Konstanz · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2019, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
7 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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. Psychological stress due to past political crises diminishes parents' ability to provide a safe environment for their children and often leads to maltreatment in the families. 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 to prevent them from losing family cohesion due to poverty and lack of support. 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 individual trauma treatment aims also at reducing aggression problems frequently associated with trauma in order to reduce negative consequences for the children. The group sessions for parents aim to address subjects such as parenting skills, alcohol abuse, family planning, and conflicts amongst couples. The family visits aim at reinforcing communication between children and their parents. 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. In the long term, parents are to set up savings and micro credit groups in order to ensure the education of the children. This multifactorial design should help to reduce the above-mentioned main risk factors for living on the street. The project involves 40 families, which are particularly affected by poverty and traumatic experiences. The legal guardians within the families are identified at the beginning of the project and directly involved to strengthen upbringing skills, to improve the economic situation of the family and to enable the adults affected by the violent political crises in Burundi to deal with their own psychological problems. In addition, one child between the ages of 5 and 20 per family is identified as the main beneficiary. This serves to gain a deeper insight into the family's communication and, in particular, to take sufficient account of the children's perspective. Through the integral approach of the project, which guarantees psychological, medical, social, legal and economic support, the children are to be protected from increasing violence on the streets and from family violence in the long term. The project is based on scientific findings of the implementing organizations, which carried out similar projects in Burundi in the last years.

02

Conditions studied

  • Posttraumatic Stress Disorder
  • Aggressive Behaviour
  • Parental Maltreatment
  • Days Spent at the Landfill
03

In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's enrollment of 150 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

University of Konstanz is the lead sponsor of 51 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Psychotic symptoms
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Intervention group

    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
    No intervention group

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

Interventions

  • BehavioralComprehensive family intervention including individual sessions of FORNET

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline; 5 months follow-up; 9 months follow-up

  2. 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

    Time frame: baseline; 5 months follow-up; 9 months follow-up

  3. 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

    Time frame: baseline; 5 months follow-up; 9 months follow-up

  4. 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

    Time frame: baseline; 5 months follow-up; 9 months follow-up

  5. In children: Change of number of days spent at the landfill

    during the last 14 days; sum ranges from 0 - 14

    Time frame: baseline; 5 months follow-up; 9 months follow-up

07

Study locations

1 site
  • vivo international & Psychologues sans Frontières mental health center
    Bujumbura, Bujumbura Mairie, Burundi
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04061954
Lead sponsor
University of Konstanz
Collaborators
Vivo international e.V., Psychologues sans Frontières Burundi, Université Lumière de Bujumbura
Responsible party
Anselm Crombach (Principal investigator, University of Konstanz) — Principal investigator
First posted
Aug 20, 2019
Start date
Apr 6, 2019
Primary completion
May 27, 2020
Completion
May 27, 2020
Last update
Nov 1, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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