Posttraumatic Stress DisorderNCT04061954
Umuryango Ukomera Uri Hamwe - Families Are Strong Together
A study testing Comprehensive family intervention including individual sessions of FORNET in people with Posttraumatic Stress Disorder and Aggressive Behaviour, run by University of Konstanz at 1 site in Burundi.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Aggressive Behaviour, Parental Maltreatment
- What is being tested?
- Comprehensive family intervention including individual sessions of FORNET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBurundi
- Study dates
- 6 Apr 2019to 27 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychotic symptoms
Trial locations and contacts
1 site in 1 country.
Burundi1 site
vivo international & Psychologues sans Frontières mental health center
Bujumbura, Bujumbura Mairie Province
About this study
Official title: 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.
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.
- Conditions
- Posttraumatic Stress Disorder, Aggressive Behaviour, Parental Maltreatment, Days Spent at the Landfill
- Being tested
- Comprehensive family intervention including individual sessions of FORNET
- Medical subject headings
- Stress Disorders, Post-Traumatic, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive family intervention including individual sessions of FORNETBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline; 5 months follow-up; 9 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start6 Apr 2019
- Primary completion27 May 2020
- Study completion27 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- Vivo international e.V., Psychologues sans Frontières Burundi, Université Lumière de Bujumbura
- Responsible party
- Principal investigator, Anselm Crombach, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061954
- Sponsor's protocol ID
- UKCR19
- Status last verified
- Oct 2021
- First submitted
- 17 Aug 2019
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Family Cohesion Using a Comprehensive Family Program Addressing Parental Skills and Mental Health Issues in Traumatised Parents in Burundi
- ClinicalTrials.gov ID
- NCT04061954
- Acronym / sponsor ID
- UKCR19
- Conditions
- Posttraumatic Stress Disorder, Aggressive Behaviour, Parental Maltreatment, Days Spent at the Landfill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- Vivo international e.V., Psychologues sans Frontières Burundi, Université Lumière de Bujumbura
- Study start
- 6 Apr 2019 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Comprehensive family intervention including individual sessions of FORNETFamilies 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 |
| 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. |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Psychotic symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive family intervention including individual sessions of FORNETFamilies 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 | Behavioural | Intervention group |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive family intervention including individual sessions of FORNET in people with Posttraumatic Stress Disorder and Aggressive Behaviour, run by University of Konstanz at 1 site in Burundi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burundi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.