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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Konstanz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vivo international e.V.
Psychologues sans Frontières Burundi
Université Lumière de Bujumbura

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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