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

Primary Purpose

Posttraumatic Stress Disorder, Mental Health Issue, Family Dynamics

Status
Completed
Phase
Not Applicable
Locations
Burundi
Study Type
Interventional
Intervention
Preventive Narrative Exposure Therapy (PreNET) family intervention
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Posttraumatic Stress Disorder

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

  • vivo international & Psychologues sans Frontières mental health center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Preventive Narrative Exposure Therapy (PreNET) family intervention

No Intervention group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 12, 2021
Last Updated
May 16, 2023
Sponsor
University of Konstanz
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1. Study Identification

Unique Protocol Identification Number
NCT05136105
Brief Title
Preventing Trauma Symptoms in the Aftermath of Sexual Abuse in Children and Adolescents in Burundi
Official Title
Preventing Trauma Symptoms in the Aftermath of Sexual Abuse in Children and Adolescents in Burundi
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
November 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Mental Health Issue, Family Dynamics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preventive Narrative Exposure Therapy (PreNET) family intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
No Intervention group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Preventive Narrative Exposure Therapy (PreNET) family intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
1. Change in mental health measured via the Strengths and Difficulties Questionnaire (SDQ)
Description
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
Title
2. Change in PTSD symptom severity measured via the University of California in Los Angeles(UCLA)-PTSD Reaction Index
Description
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 Outcome Measure Information:
Title
3. Change in abuse-related parental acceptance-rejection
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Psychotic symptoms Cognitive disability Current use of mind altering drugs
Facility Information:
Facility Name
vivo international & Psychologues sans Frontières mental health center
City
Bujumbura
State/Province
Bujumbura Mairie
Country
Burundi

12. IPD Sharing Statement

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

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