Posttraumatic Stress DisorderNCT05136105
Preventing Trauma Symptoms in the Aftermath of Sexual Abuse in Children and Adolescents in Burundi
A study testing Preventive Narrative Exposure Therapy (PreNET) family intervention in people with Posttraumatic Stress Disorder and Mental Health Issue, run by University of Konstanz at 1 site in Burundi.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Mental Health Issue, Family Dynamics
- What is being tested?
- Preventive Narrative Exposure Therapy (PreNET) family intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBurundi
- Study dates
- 10 Mar 2021to 10 Nov 2022
- Phase
- Interventional
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Sexual abuse within the past month
- Participants are recruited when they approach a first aid center for survivors of sexual abuse
Who cannot join
- Psychotic symptoms
- Cognitive disability
- Current use of mind altering drugs
Trial locations and contacts
1 site in 1 country.
Burundi1 site
vivo international & Psychologues sans Frontières mental health center
Bujumbura, Bujumbura Mairie Province
About this study
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.
- Being tested
- Preventive Narrative Exposure Therapy (PreNET) family intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive Narrative Exposure Therapy (PreNET) family interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3-month follow-up; 12-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start10 Mar 2021
- Primary completion10 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 150 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136105
- Sponsor's protocol ID
- UKAC2021
- Status last verified
- May 2023
- First submitted
- 12 Nov 2021
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40347425
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Trauma Symptoms in the Aftermath of Sexual Abuse in Children and Adolescents in Burundi
- ClinicalTrials.gov ID
- NCT05136105
- Acronym / sponsor ID
- UKAC2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 26 Nov 2021 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Preventive Narrative Exposure Therapy (PreNET) family intervention | Experimental | Behavioral: Preventive Narrative Exposure Therapy (PreNET) family interventionThe 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. |
| 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Sexual abuse within the past month
- Participants are recruited when they approach a first aid center for survivors of sexual abuse
Key exclusion criteria (3 listed)
- Psychotic symptoms
- Cognitive disability
- Current use of mind altering drugs
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 |
|---|---|---|
| Preventive Narrative Exposure Therapy (PreNET) family interventionSessions: (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. | Behavioural | Preventive Narrative Exposure Therapy (PreNET) family intervention |
Primary outcome
1. Change in mental health measured via the Strengths and Difficulties Questionnaire (SDQ)
Time frame: baseline; 3-month follow-up; 12-months follow-up
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
Time frame: 3-month follow-up; 12-months follow-up
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.
1 secondary outcome
3. Change in abuse-related parental acceptance-rejection
Time frame: 3-month follow-up; 12-months follow-up
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 17 May 2023.
- Derived from this study: PubMed 40347425Schneider 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive Narrative Exposure Therapy (PreNET) family intervention in people with Posttraumatic Stress Disorder and Mental Health Issue, 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 3 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 17 May 2023. 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.
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?
1. Change in mental health measured via the Strengths and Difficulties Questionnaire (SDQ) (time frame: baseline; 3-month follow-up; 12-months follow-up). 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?
On the ClinicalTrials.gov record for NCT05136105, which also lists 1 linked publication.
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 17 May 2023.