Posttraumatic Stress DisorderNCT03846154
Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Mental Health Symptoms
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 at the landfills of Bujumbura are often exposed to maltreatment, including emotional neglect and physical abuse, and traumatic experiences. Furthermore, they grow up in severe poverty. Read more about this study
- Who is it for?
- Ages 7 to 18 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
- 96 participants
- Where
- 1 siteBurundi
- Study dates
- 1 Mar 2018to 30 Mar 2019
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Spending days at the landfills of Bujumbura
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: Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Trauma-related Mental Health Symptoms
Children living at the landfills of Bujumbura are often exposed to maltreatment, including emotional neglect and physical abuse, and traumatic experiences. Furthermore, they grow up in severe poverty. Addressing trauma-related mental health issues and aggressive behaviour by Narrative Exposure Therapy (FORNET), familial communication by family visits, interaction difficulties of children by a group intervention, poverty by financial support and economic training for mothers, medical problems by medical assistance, legal conflicts by legal advice, and providing access to school, we aimed at reintegrating those children within the Burundian school system and improving familial relationships.
The investigators want to provide evidence, that mental health interventions are an integral part of assisting children and families affected by poverty and violence.
- 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
- A group intervention once a week for about 20 weeks, including psychoeducation on mental health and drug abuse, anger management, roles within families, developing plans for the future, communication skills, sex education.
- Access to schools and school material
- Family visits
- Their parents received training regarding agriculture and microcredit projects, and financial assistance
- FORNET if affected by trauma-related symptoms, and/or acting aggressive
- If needed medical assistance /.) If needed, legal assistance
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Children and adolescents in the intervention group received:
1. A group intervention once a week for about 20 weeks, including psychoeducation on mental health and drug abuse, anger management, roles within families, developing plans for the future, communication skills, sex education.
2. Access to schools and school material
3. Family visits
4. Their parents received training regarding agriculture and microcredit projects, and financial assistance
5. FORNET if affected by trauma-related symptoms, and/or acting aggressive
6. If needed medical assistance is provided
7. If needed legal assistance is provided Receives: Behavioral: Comprehensive family intervention including individual sessions of FORNET |
| Control 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.
Change of load of traumatic symptoms measured via the University of California at Los Angeles Posttraumatic Stress Disorder Reaction Index (scale administered by Clinicians)
27 items assessing PTSD, 4 additional items assessing dissociation on a scale from 0 - 4. Due to scoring rules, 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; all items are summed up for the total score
Measured: baseline; 5 months follow-up; 9 months follow-up
Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence Checklist
32 items; answer categories: yes or no; sum score ranges from 0 - 32
Measured: baseline; 5 months follow-up; 9 months follow-up
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
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 posted19 Feb 2019
- Study start1 Mar 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
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
- 96 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
- NCT03846154
- Sponsor's protocol ID
- UKCR18
- Status last verified
- Apr 2019
- First submitted
- 15 Feb 2019
- Last updated
- 25 Apr 2019
- 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 IPD with other researchers not related to the institutions conducting the study. If data is shared, the PI will supervise those analysing the date, e.g., students writing their theses
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Trauma-related Mental Health Symptoms
- ClinicalTrials.gov ID
- NCT03846154
- Acronym / sponsor ID
- UKCR18
- Conditions
- Posttraumatic Stress Disorder, Aggressive Behaviour, Parental Maltreatment, Days Spent at the Landfill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 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
- 1 Mar 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 19 Feb 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 at the landfills of Bujumbura are often exposed to maltreatment, including emotional neglect and physical abuse, and traumatic experiences. Furthermore, they grow up in severe poverty. Addressing trauma-related mental health issues and aggressive behaviour by Narrative Exposure Therapy (FORNET), familial communication by family visits, interaction difficulties of children by a group intervention, poverty by financial support and economic training for mothers, medical problems by medical assistance, legal conflicts by legal advice, and providing access to school, we aimed at reintegrating those children within the Burundian school system and improving familial relationships.
The investigators want to provide evidence, that mental health interventions are an integral part of assisting children and families affected by poverty and violence.
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 FORNETChildren and adolescents in the intervention group received: 1. A group intervention once a week for about 20 weeks, including psychoeducation on mental health and drug abuse, anger management, roles within families, developing plans for the future, communication skills, sex education. 2. Access to schools and school material 3. Family visits 4. Their parents received training regarding agriculture and microcredit projects, and financial assistance 5. FORNET if affected by trauma-related symptoms, and/or acting aggressive 6. If needed medical assistance is provided 7. If needed legal assistance is provided |
| Control 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 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Spending days at the landfills of Bujumbura
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 FORNET1. A group intervention once a week for about 20 weeks, including psychoeducation on mental health and drug abuse, anger management, roles within families, developing plans for the future, communication skills, sex education. 2. Access to schools and school material 3. Family visits 4. Their parents received training regarding agriculture and microcredit projects, and financial assistance 5. FORNET if affected by trauma-related symptoms, and/or acting aggressive 6. If needed medical assistance /.) If needed, legal assistance | Behavioural | Intervention group |
Primary outcome
Change of load of traumatic symptoms measured via the University of California at Los Angeles Posttraumatic Stress Disorder Reaction Index (scale administered by Clinicians)
Time frame: baseline; 5 months follow-up; 9 months follow-up
27 items assessing PTSD, 4 additional items assessing dissociation on a scale from 0 - 4. Due to scoring rules, 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; all items are summed up for the total score
Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence Checklist
Time frame: baseline; 5 months follow-up; 9 months follow-up
32 items; answer categories: yes or no; sum score ranges from 0 - 32
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
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 25 Apr 2019.
- Individual participant dataSharing planned: No. Currently there is no plan to share IPD with other researchers not related to the institutions conducting the study. If data is shared, the PI will supervise those analysing the date, 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 1 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 25 Apr 2019. 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?
Change of load of traumatic symptoms measured via the University of California at Los Angeles Posttraumatic Stress Disorder Reaction Index (scale administered by Clinicians) (time frame: baseline; 5 months follow-up; 9 months follow-up). The study lists 4 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 25 Apr 2019.