- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04061954
Umuryango Ukomera Uri Hamwe - Families Are Strong Together
October 29, 2021 updated by: Anselm Crombach, University of Konstanz
Improving Family Cohesion Using a Comprehensive Family Program Addressing Parental Skills and Mental Health Issues in Traumatised Parents in Burundi
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bujumbura Mairie
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Bujumbura, Bujumbura Mairie, Burundi
- vivo international & Psychologues sans Frontières mental health center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- Psychotic symptoms
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Families in the intervention group received:
|
Families in the intervention group received:
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
Time Frame: baseline; 5 months follow-up; 9 months follow-up
|
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
Time Frame: baseline; 5 months follow-up; 9 months follow-up
|
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
Time Frame: baseline; 5 months follow-up; 9 months follow-up
|
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)
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
|
baseline; 5 months follow-up; 9 months follow-up
|
|
In children: 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
|
baseline; 5 months follow-up; 9 months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 2019
Primary Completion (Actual)
May 27, 2020
Study Completion (Actual)
May 27, 2020
Study Registration Dates
First Submitted
August 17, 2019
First Submitted That Met QC Criteria
August 17, 2019
First Posted (Actual)
August 20, 2019
Study Record Updates
Last Update Posted (Actual)
November 1, 2021
Last Update Submitted That Met QC Criteria
October 29, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKCR19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.