Aggressive BehaviorPhase 2NCT01519193
Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder
A Phase 2 study testing Narrative Exposure Therapy for violent offenders (NETvo) in people with Aggressive Behavior and Post-Traumatic Stress Disorder, run by University of Konstanz at 1 site in Burundi.
Trial summary
Street children and children of vulnerable families in conflict or former conflict regions are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. Read more about this study
- Who is it for?
- Ages 12 to 23 years, men only
- Conditions the study is for
- Aggressive Behavior, Post-Traumatic Stress Disorder
- What is being tested?
- Narrative Exposure Therapy for violent offenders (NETvo)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBurundi
- Study dates
- Jan 2011to May 2012
- Phase
- Phase 2
- 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 12 to 23 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Positive Emotions concerning aggressive behavior derived from expert interviews with higher Scores of the Appetitive Aggression Scale (AAS)
- children are part of an aid program for reintegration into society
Who cannot join
- current substance dependance or use of antipsychotic drugs
- chronically ill children
Trial locations and contacts
1 site in 1 country.
Burundi1 site
Fondation Stamm
Bujumbura, Bujumbura Mairie Province
About this study
Official title: Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder in Former Street Children and Vulnerable Children in Burundi With Narrative Exposure Therapy for Violent Offenders
Street children and children of vulnerable families in conflict or former conflict regions are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. The Narrative Exposure Therapy for violent offenders (NETvo) aims to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful experiences and positive emotions linked to violent behaviour in the past. Additionally, visions for the future are developed in order to foster successful reintegration into society.
- Being tested
- Narrative Exposure Therapy for violent offenders (NETvo)
- Keywords
- Aggressive Behavior, Appetitive Aggression, Post-Traumatic Stress Disorder
- Medical subject headings
- Aggression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure Therapy for violent offenders (NETvo)Behavioural
During NETvo the client, with the assistance of the therapist, constructs a chronological narrative of his whole life with a focus on exposure to traumatic stress and also on perpetrated violent acts. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior who asks in detail for emotions, cognitions, sensory information, and physiological reactions, linking them to an autobiographical context. Positive emotions and cognitions reported for violent acts are linked to the respective past. During four sessions the most important traumatic experiences and perpetrated violent acts are processed. In the fifth session plans and ideas for the future are developed to assist the children to reintegrate themselves into society.
| Study group | Role | What they receive |
|---|---|---|
| Narrative Exposure Therapy | Experimental | Not described Receives: Behavioral: Narrative Exposure Therapy for violent offenders (NETvo) |
| No treatment control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive emotions linked to aggressive behavior via the AAS-CS (Appetitive Aggressions Scale for children and students)
Measured: 6 months
Load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (Clinician-administered PTSD scale)
Measured: 6 months
Secondary outcomes (3)
Load of depressive symptoms measured via the MINI-KID
Measured: 6 months
Strength of suicidal ideation measured via the MINI-KID
Measured: 6 months
Functionality measured via the CGAS (Children's Global Assessment Scale) and SDQ (Strengths and Difficulties Questionnaire)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive BehaviorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anselm Crombach, University of Konstanz
- Investigators
- Anselm Crombach, Dipl.-Psych., Principal investigator, University of Constance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519193
- Sponsor's protocol ID
- UKCR2011
- Status last verified
- Nov 2012
- First submitted
- 1 Dec 2011
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder in Former Street Children and Vulnerable Children in Burundi With Narrative Exposure Therapy for Violent Offenders
- ClinicalTrials.gov ID
- NCT01519193
- Acronym / sponsor ID
- UKCR2011
- Keywords
- Aggressive Behavior, Appetitive Aggression, Post-Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Jan 2012 (estimated)
- 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.
Street children and children of vulnerable families in conflict or former conflict regions are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. The Narrative Exposure Therapy for violent offenders (NETvo) aims to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful experiences and positive emotions linked to violent behaviour in the past. Additionally, visions for the future are developed in order to foster successful reintegration into society.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrative Exposure Therapy | Experimental | Behavioral: Narrative Exposure Therapy for violent offenders (NETvo) |
| No treatment control | No intervention | – |
Who may qualify
- Ages
- 12 to 23 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Positive Emotions concerning aggressive behavior derived from expert interviews with higher Scores of the Appetitive Aggression Scale (AAS)
- children are part of an aid program for reintegration into society
Key exclusion criteria (2 listed)
- current substance dependance or use of antipsychotic drugs
- chronically ill children
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 |
|---|---|---|
| Narrative Exposure Therapy for violent offenders (NETvo)During NETvo the client, with the assistance of the therapist, constructs a chronological narrative of his whole life with a focus on exposure to traumatic stress and also on perpetrated violent acts. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior who asks in detail for emotions, cognitions, sensory information, and physiological reactions, linking them to an autobiographical context. Positive emotions and cognitions reported for violent acts are linked to the respective past. During four sessions the most important traumatic experiences and perpetrated violent acts are processed. In the fifth session plans and ideas for the future are developed to assist the children to reintegrate themselves into society. | Behavioural | Narrative Exposure Therapy |
Primary outcome
Positive emotions linked to aggressive behavior via the AAS-CS (Appetitive Aggressions Scale for children and students)
Time frame: 6 months
Load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (Clinician-administered PTSD scale)
Time frame: 6 months
3 secondary outcomes
Load of depressive symptoms measured via the MINI-KID
Time frame: 6 months
Strength of suicidal ideation measured via the MINI-KID
Time frame: 6 months
Functionality measured via the CGAS (Children's Global Assessment Scale) and SDQ (Strengths and Difficulties Questionnaire)
Time frame: 6 months
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 7 Nov 2012.
Related trials for Aggressive Behavior
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Active, not recruitingPhase 1/2
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
DLBCL, High-grade B-cell Lymphoma (HGBCL)
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.
Anselm Crombach, Dipl.-Psych. principal investigator
University of Constance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Narrative Exposure Therapy for violent offenders (NETvo) in people with Aggressive Behavior and Post-Traumatic Stress Disorder, 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 2 inclusion and 2 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 7 Nov 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Positive emotions linked to aggressive behavior via the AAS-CS (Appetitive Aggressions Scale for children and students) (time frame: 6 months). The study lists 2 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 7 Nov 2012.