NCT02503488

Brief Summary

The purpose of the current study is to examine the psychological well-being of youth within the context of participation in political violence during the 2015 election period in Burundi. In detail, the investigators are interested in fostering improved outcomes in a peace-building initiative aimed at youth in Burundi by reducing the mental health-related stress of the initiative's most severely affected participants. In addition, the investigators are interested in learning more about the youth experience of involvement in the Burundian political system in an effort to understand the links between youth engagement in political violence and past experiences of traumatic events.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

June 30, 2015

Last Update Submit

November 27, 2017

Conditions

Keywords

Appetitive Aggression

Outcome Measures

Primary Outcomes (3)

  • Change in Baseline PTSD Scores at 3-months-followup and 9-months-followup

    Will be assessed using the PSS-I

    Baseline, 3 months, 9 months

  • Change in Baseline Depression Scores at 3-months-followup and 9-months-followup

    Will be assessed using the Patient Health Questionnaire-9

    Baseline, 3 months, 9 months

  • Change in Baseline Appetitive Aggression Scores at 3-months-followup and 9-months-followup

    Assesses attitudes towards the perception and disposition of different forms of violence using the Appetitive Aggression Scale for Children (AAS-C).

    Baseline, 3 months, 9 months

Secondary Outcomes (3)

  • Change in Baseline Physical State at 3-months-followup and 9-months-followup

    Baseline, 3 months, 9 months

  • Change in Social Integration Scores at 3-months-followup and 9-months-followup

    Baseline, 3 months, 9 months

  • Change in Scores on the Attitudes Toward Members of Other Political Parties Scale at 3-months-followup and 9-months-followup

    Baseline, 3 months, 9 months

Other Outcomes (1)

  • Change in Scores on the Opinion on the Civil War Scale at 3-months-followup and 9-months-followup

    Baseline, 3 months, 9 months

Study Arms (2)

Program Group

EXPERIMENTAL

The treatment arm will consist of 20 randomly selected participants who will receive Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) for their traumatic symptomology, aggression, and depression. FORNET consists of a guided exposure of the participant's traumatic experiences in chronological order and integrating them into a coherent biographical memory.The intervention addresses the participant's positive, negative, and violent memories of events that have taken place during their lifetime, and also provides participants an opportunity to asses their current situation and future plans. FORNET can be completed in six sessions and each session lasts 90 minutes on average.

Behavioral: Narrative Exposure Therapy for Forensic Offender Rehab

Treatment As Usual (TAU)

ACTIVE COMPARATOR

Participants in the TAU group will receive group and individual psycho-social support from trained peer-support workers, with 10 sessions occurring throughout the course of the intervention for each participant. In addition, there will be sensitisation trainings as well as mentoring for establishing greater financial independence. Last, TAU will include one-day events promoting social cohesion and peace.

Behavioral: Treatment as Usual

Interventions

See arm description.

Also known as: FORNET
Program Group

See arm description

Also known as: TAU
Treatment As Usual (TAU)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • High degree of symptoms of posttraumatic stress disorder according to the Posttraumatic Symptom Scale
  • High degree of appetitive aggression
  • Violent behavior during the past three months

You may not qualify if:

  • Current use of mind altering drugs
  • Psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

vivo international & Psychologues sans Frontières mental health center

Bujumbura, Burundi

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAggression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorAberrant Motor Behavior in DementiaSocial Behavior

Study Officials

  • Anselm Crombach

    University of Konstanz, vivo international e.V., Psychologues sans Frontiers Burundi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Anselm Crombach, Dipl.-Psych.

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 21, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations