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Umuryango Ukomera Uri Hamwe - Families Are Strong Together

Primary Purpose

Posttraumatic Stress Disorder, Aggressive Behaviour, Parental Maltreatment

Status
Completed
Phase
Not Applicable
Locations
Burundi
Study Type
Interventional
Intervention
Comprehensive family intervention including individual sessions of FORNET
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

7 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • vivo international & Psychologues sans Frontières mental health center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

No intervention group

Arm Description

Families in the intervention group received: 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 Family visits to address topics as family cohesion, intra-familial communication and psychological basic need of children Trauma-focused therapies Parents receive training regarding agriculture and micro credit projects, and financial assistance One child per family receives a social skill training group preparing them for returning to school Access to schools and school material If needed medical assistance is provided If needed legal assistance is provided

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

Outcomes

Primary Outcome Measures

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
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
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
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
In children: Change of number of days spent at the landfill
during the last 14 days; sum ranges from 0 - 14

Secondary Outcome Measures

Full Information

First Posted
August 17, 2019
Last Updated
October 29, 2021
Sponsor
University of Konstanz
Collaborators
Vivo international e.V., Psychologues sans Frontières Burundi, Université Lumière de Bujumbura
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1. Study Identification

Unique Protocol Identification Number
NCT04061954
Brief Title
Umuryango Ukomera Uri Hamwe - Families Are Strong Together
Official Title
Improving Family Cohesion Using a Comprehensive Family Program Addressing Parental Skills and Mental Health Issues in Traumatised Parents in Burundi
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 6, 2019 (Actual)
Primary Completion Date
May 27, 2020 (Actual)
Study Completion Date
May 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
Vivo international e.V., Psychologues sans Frontières Burundi, Université Lumière de Bujumbura

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Aggressive Behaviour, Parental Maltreatment, Days Spent at the Landfill

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Families in the intervention group received: 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 Family visits to address topics as family cohesion, intra-familial communication and psychological basic need of children Trauma-focused therapies Parents receive training regarding agriculture and micro credit projects, and financial assistance One child per family receives a social skill training group preparing them for returning to school Access to schools and school material If needed medical assistance is provided If needed legal assistance is provided
Arm Title
No intervention group
Arm Type
No Intervention
Arm Description
The control group was invited to participate in three interviews getting small amounts of money (~2,5 €) as decompensation of their time.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive family intervention including individual sessions of FORNET
Intervention Description
Families in the intervention group received: 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 Family visits to address topics as family cohesion, intra-familial communication and psychological basic need of children Trauma-focused therapies (FORNET), which aim also at reducing violent behaviour Parents receive training regarding agriculture and micro credit projects, and financial assistance One child per family receives a social skill training group preparing them for returning to school Access to schools and school material If needed medical assistance is provided If needed legal assistance is provided
Primary Outcome Measure Information:
Title
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)
Description
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
Title
In parents: Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence
Description
32 items; answer categories: yes or no; sum score ranges from 0 - 32
Time Frame
baseline; 5 months follow-up; 9 months follow-up
Title
In children: Change in experienced parental rejection measured via the short version of the Parental Acceptance Rejection Questionnaire
Description
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
Title
In children: Change of experienced parental maltreatment measured via a shortened version of the Maltreatment and Abuse Chronology of Exposure (MACE)
Description
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
Title
In children: Change of number of days spent at the landfill
Description
during the last 14 days; sum ranges from 0 - 14
Time Frame
baseline; 5 months follow-up; 9 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
vivo international & Psychologues sans Frontières mental health center
City
Bujumbura
State/Province
Bujumbura Mairie
Country
Burundi

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Umuryango Ukomera Uri Hamwe - Families Are Strong Together

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