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CompletedNCT05136105Updated May 17, 2023

Preventing Trauma Symptoms in the Aftermath of Sexual Abuse in Children and Adolescents in Burundi

An interventional study of Preventive Narrative Exposure Therapy (PreNET) family intervention in Posttraumatic Stress Disorder, Mental Health Issue and Family Dynamics, sponsored by University of Konstanz. Completed at 1 site in Burundi. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-05-17.

Sponsored by University of Konstanz · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Mar 2021, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
7 Years to 18 Years
Sex
All
01

Study summary

Survivors of sexual violence are particularly vulnerable to develop psychological as well as physical health problems, Burundian children and adolescents being at elevated risk. Psychosocial care, and trauma-focused interventions, nevertheless, are near absent in Burundi.

The purpose of this project is to ameliorate psychosocial care for survivors of sexual violence in strengthening health care competencies by implementing evidence-based intervention strategies. We intend to develop an approach identifying particularly vulnerable children and adolescents and testing a preventive family-oriented psychotherapeutic approach. The latter aims at reducing stigmatization and at promoting the processing of the event within families. The project involves two cohorts, which are assessed enrolling them in the study, during a three-months and a 12-months follow-up.

Read the detailed description

Survivors of sexual violence are particularly vulnerable to develop psychological as well as physical health problems, children and adolescents being at particular risk. Residing in conflict zones with disrupted community structures and social norms, substantially increases the risk for interpersonal violence, especially sexual abuse. The post-war country Burundi shows high prevalence rates for childhood sexual abuse. Adequate psychosocial care and trauma-focused interventions, however, are near absent, especially in rural areas.

Furthermore, talking about sexual activities remains a taboo-topic in Burundi, and particularly talking about sexual abuse. Survivors often suffer from stigmatization and therefore conceal their abusive experience. Recent studies, however, accentuate the importance of social support, notably parental acceptance, in the aftermath of sexual abuse. Parental acceptance shows buffering effects of sequelae following sexual abuse. Conversely, parental rejection, especially coming from the father, lowers the self-esteem and leads to emotional unresponsiveness and negative self-cognitions. Rejection thus risks to exacerbate feelings of shame and the internalization of stigma. Hence, the implementation of family-oriented interventions is crucial for effective treatment outcomes.

The purpose of this project is thus to ameliorate psychosocial care for survivors of sexual violence in strengthening health care competencies by implementing evidence-based intervention strategies. Combining insights from the aforementioned research, cognitive behavioural strategies, and cultural aspects we developed a preventive treatment approach aiming to address (1) the building block effect using trauma-therapeutic methods, (2) social exclusion by family members and society, and (3) communication about the incident and associated emotions within the family. The intervention consisted of three sessions. The first cohort included in the study does not receive the intervention in order to establish a baseline assessment of the course of mental health symptoms in the aftermath of sexual violence, and to help identify those in need of psychosocial assistance. The second cohort is offered the family intervention.

Follow-up assessments are planned at 3 and 12 months.

02

Conditions studied

  • Posttraumatic Stress Disorder
  • Mental Health Issue
  • Family Dynamics
03

In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's enrollment of 150 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

University of Konstanz is the lead sponsor of 51 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Sexual abuse within the past month
  • Participants are recruited when they approach a first aid center for survivors of sexual abuse

Exclusion criteria

Exclusion Criteria:

  • Psychotic symptoms
  • Cognitive disability
  • Current use of mind altering drugs
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Preventive Narrative Exposure Therapy (PreNET) family intervention

    The intervention group receives treatment as usual in the first aid center for survivors of sexual abuse. This includes medical and judicial assistance if necessary. Furthermore, they receive the psychological family focused intervention. The intervention consists of a total of three sessions with the aim of reestablishing and validating the relationship between sexually abused children and their parents. The intervention focuses on psychoeducation regarding shame and other trauma related disorders. Further, the acknowledgement of shame and embarrassment as well as parental skills are intended to be improved.

    Behavioral: Preventive Narrative Exposure Therapy (PreNET) family intervention

  • No intervention
    No Intervention group

    The control group will receive only the assessments, and treatment as usual in a first aid center for survivors of sexual abuse. This includes usually a brief assessment of what happened as well as medical and judicial assistance if necessary.

Interventions

  • BehavioralPreventive Narrative Exposure Therapy (PreNET) family intervention

    Sessions: (1) Participants are invited to narrate the event in detail, in line with the protocol of the trauma-focused intervention NET. Furthermore, participants and caregiver(s) will receive a brief psychoeducation about expected symptoms and supportive behaviour in the aftermath of sexual violence. (2) Two weeks after session 1, the second session focuses on caregiver only and their emotions. The narration of the event is read to the caregiver(s). Caregiver(s) receive assistance regulating their emotions. They receive psychoeducation on how to support their child. (3) Two weeks after the second session, the children assisted by their caregivers lay a chronological lifeline of their most important life experiences. The chronology and the context of the traumatic events is reinforced. The narration of the sexual abuse is read again to the child and the caregiver(s). The caregiver(s) are encouraged to support emotionally their child during the renarration.

06

What researchers measure

Primary outcomes

  1. 1. Change in mental health measured via the Strengths and Difficulties Questionnaire (SDQ)

    25 items, 5 subscales (conduct problems, hyperreactivity, emotional symptoms, peer problems, pro-social behavior), answer categories: 0 (not true) - 2 (certainly true). Subscale scores ranging from 0 - 10, overall score ranges from 0 - 40.

    Time frame: baseline; 3-month follow-up; 12-months follow-up

  2. 2. Change in PTSD symptom severity measured via the University of California in Los Angeles(UCLA)-PTSD Reaction Index

    27 items (DSM-5 diagnostic criteria for PTSD); answer categories frequency scored: 0 (none of the time) - 4 (all of the time). Overall score ranges from 0 - 80.

    Time frame: 3-month follow-up; 12-months follow-up

Secondary outcomes

  1. 3. Change in abuse-related parental acceptance-rejection

    Parental Acceptance and Rejection Questionnaire, short form; 24 items ranging from 1 - 4. Overall score ranges from 24 - 96.

    Time frame: 3-month follow-up; 12-months follow-up

07

Study locations

1 site
  • vivo international & Psychologues sans Frontières mental health center
    Bujumbura, Bujumbura Mairie, Burundi
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05136105
Lead sponsor
University of Konstanz
Responsible party
Anselm Crombach (Principal Investigator, University of Konstanz) — Principal investigator
First posted
Nov 26, 2021
Start date
Mar 10, 2021
Primary completion
Nov 10, 2022
Completion
Nov 10, 2022
Last update
May 17, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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