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

NCT05136105 | Completed DMC

• 1 other identifier: UKAC2021
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder; Mental Health Issue; Family Dynamics

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline; 3-month follow-up; 12-months follow-up

• 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.

  3-month follow-up; 12-months follow-up

Secondary Outcomes (1)

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

  3-month follow-up; 12-months follow-up

Study Arms (2)

Preventive Narrative Exposure Therapy (PreNET) family intervention

EXPERIMENTAL

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 group

NO INTERVENTION

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

Preventive Narrative Exposure Therapy (PreNET) family intervention BEHAVIORAL

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.

Preventive Narrative Exposure Therapy (PreNET) family intervention

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Konstanz: lead

Study Sites (1)

vivo international & Psychologues sans Frontières mental health center

Bujumbura, Bujumbura Mairie Province, Burundi

Location

Related Publications (1)

• Schneider J, Rukundo-Zeller AC, Bambonye M, Muhoza JA, Ndayikengurukiye T, Nitanga L, Rushoza AA, Crombach A. Preventing Childhood Sexual Abuse Related Mental Health Deterioration Using a Narrative Family Intervention in Burundi. Res Child Adolesc Psychopathol. 2025 Jul;53(7):1061-1076. doi: 10.1007/s10802-025-01328-8. Epub 2025 May 10.

  PMID: 40347425 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two cohorts. The first cohort receiving treatment as usual in Burundi, mostly a waiting control group, the second cohort receiving a three session family focused intervention.

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 26, 2021
• Study Start: March 10, 2021
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

BU (1)