Post-Traumatic Stress Disorder in ChildrenNCT04866511
Video NET With CYP Who Witnessed Domestic Violence
A study testing Narrative Exposure Therapy in people with Post-Traumatic Stress Disorder in Children and Post-Traumatic Stress Disorder in Adolescence, run by University of Nottingham at 2 sites in United Kingdom.
Trial summary
Research suggests that children and young people (CYP) who witness domestic violence are susceptible to develop Post-traumatic stress (PTS). As their traumatic experiences are often repeated and prolonged, these CYP are likely to present with 'complex trauma' presentations, which also include other difficulties such… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Post-Traumatic Stress Disorder in Children, Post-Traumatic Stress Disorder in Adolescence, Post-Traumatic Stress Disorder Complex
- What is being tested?
- Narrative Exposure Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 13 Apr 2021to 11 Apr 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be aged 12- 17;
- Have witnessed domestic violence in the past;
- Be experiencing clinical levels of post-traumatic stress, as assessed by a member of the CAMHS team;
- Be on the waiting list to receive trauma-focused treatment;
- If 16 or over, be able to consent to take part, as assessed by a member of the CAMHS team;
- If under 16, have at least one person with parental authority who can consent for them. These young people will also be asked to provide their assent;
Show all 13Show fewer
- Be able to communicate verbally and speak English;
- Have access to a device with a webcam and Internet broadband to enable participation in video sessions;
- Have access to a mobile device, e.g. a smartphone or a tablet. Can be the same as the device above.
- Exclusion Criteria - Participants will be excluded from the study if:
- They have a known diagnosis of Intellectual Disability;
- They have a current high level of risk including of self-harm, suicide or current exposure to domestic violence, as assessed by a member of the CAMHS team;
- They are substance dependent.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Lincolnshire Partnership Foundation NHS Trust - Child and Adolescent Mental Health Services
Lincoln, Lincolnshire, LN5 7RZ
Nottinghmashire Healthcare NHS Foundation Trust - Community Child and Adolescent Mental Health Services
Nottingham, Nottinghamshire, NG5 3FL
About this study
Official title: Video Narrative Exposure Therapy (NET) With Children and Young People Who Witnessed Domestic Violence: A Naturalistic Single Case Study Series
Research suggests that children and young people (CYP) who witness domestic violence are susceptible to develop Post-traumatic stress (PTS). As their traumatic experiences are often repeated and prolonged, these CYP are likely to present with 'complex trauma' presentations, which also include other difficulties such as depressive symptoms and problems in functioning.
This study aims to investigate whether Narrative Exposure Therapy (NET) delivered via videoconferencing can be effective, feasible, and acceptable for CYP who witnessed domestic violence. NET is a brief, evidence-based intervention for complex trauma which has been adapted for CYP. The study will use a 'single case study series' design and look at whether NET can impact on PTS, psychological distress, and functioning. It will also look at the processes of change within NET and participants' experience of the therapy. Young people aged 12-17 who are experiencing PTS after exposure to domestic violence will be recruited from the waiting lists of Child and Adolescent Mental Health Services in Lincolnshire Partnership NHS Foundation Trust and Nottinghamshire Healthcare NHS Foundation Trust.
Read more
Up to six participants will receive six to ten weekly video sessions and the changes in the outcomes will be explored before, during and after NET. Finally, participants will be interviewed about their experiences.
The study is part of a Doctorate in Clinical Psychology programme and funded by Health Education England. Potential benefits include investigating NET with a new group, contributing to the research on complex trauma interventions for CYP, and providing insights on the effectiveness and acceptability of therapies via video.
Read the detailed description
The purpose of the study is to investigate the potential effectiveness, feasibility, acceptability and putative mechanisms of change of video NET with children and young people who witnessed domestic violence.
The primary objective of the study is to evaluate whether video NET can reduce PTS in this group.
The secondary objectives of the study are:
- To determine whether video NET can also impact on general psychological distress and functioning;
- To examine the putative mechanisms of change within NET, i.e. habituation and integration of trauma memories;
- To explore the feasibility and acceptability of video NET.
- Conditions
- Post-Traumatic Stress Disorder in Children, Post-Traumatic Stress Disorder in Adolescence, Post-Traumatic Stress Disorder Complex, Domestic Violence, Trauma, Psychological, Narrative Exposure Therapy
- Being tested
- Narrative Exposure Therapy
- Keywords
- post-traumatic stress, narrative exposure therapy, children and young people, domestic violence, case study series
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure TherapyOther
Also called NET, KIDNET (protocol for children and adolescents)
NET is a trauma-focused psychological treatment for people who experienced multiple traumas (Schaeur et al., 2011).
An adaptation named KIDNET was developed for use with children and young people (Neuner et al., 2008; Schauer et al., 2011, 2017).
Participants will be offered 6-10 weekly sessions of NET lasting approximately 90 minutes each. The sessions will be delivered by a Trainee Clinical Psychologist via videoconferencing, in line with the UK's Government guidelines around reducing face-to-face contacts during the Covid-19 pandemic.
| Study group | Role | What they receive |
|---|---|---|
| NET intervention | Experimental | This study will follow a single case design and will involve delivering and evaluating the child-friendly protocol of NET. Therefore, there will only be one arm (NET intervention) and no comparators. Receives: Other: Narrative Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTS symptoms between the baseline, NET intervention, and 1-month follow-up phases - as assessed by the Children's Revised Impact of Event Scale (CRIES-13; Perrin et al., 2005)
The CRIES is a brief self-report questionnaire assessing PTS in children and young people aged 8-18. The original version of the scale (CRIES-8) includes 8 items evaluating intrusion and avoidance symptoms; a longer version (CRIES-13) comprising 5 additional items was developed to include the assessment of hyperarousal symptoms. The young person completing the scale is asked to rate each item depending on how frequently they experienced the symptom in the past week on a four-point scale . Although the CRIES is not a diagnostic instrument, higher scores suggest higher levels of PTS and likely clinical caseness. The scale has demonstrated good face and construct validity and has been used to screen and capture symptom change in children exposed to a variety of traumatic events (Perrin et al., 2005; Smith et al., 2003).
Measured: Throughout the study, for approximately 18 weeks
Secondary outcomes (1)
Change in pyschological distress and functioning between the baseline, NET intervention, and 1-month follow-up phases - as assessed by the Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE; Twigg et al., 2009)
The YP-CORE has been adapted from the CORE-10 for use with children and young people between 11 and 16 years. The scale is a session-by-session monitoring tool comprising items assessing anxiety symptoms, depression symptoms, physical problems, functioning and risk to self. The YP-CORE includes six high severity items and four low severity items. When completing the YP-CORE, the young person rates the 10 items based on how often they experienced each problem over the past week (0 = "Not at all", 1 = "Only occasionally", 2 = "Sometimes", 3 = "Often", 4 = "Most or all of the time"). Previous studies have demonstrated the scale's reliability, validity and sensitivity to change (Twigg et al., 2009; Twigg et al., 2016).
Measured: Throughout the study, for approximately 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start13 Apr 2021
- Primary completion11 Mar 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress Disorder in ChildrenStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will adopt a Single Case Design (SCD) methodology, and specifically a naturalistic, sequential measurement, mixed-method AB design. SCDs are an idiographic method that allows for the analysis and interpretation of change at the level of the individual, rather the group. As such, SCDs typically aim to measure the change occurring in the individual's behaviour or symptoms by comparing the baseline, the intervention and the follow-up phases in terms of trends and variability (Parsonson \& Baer, 1986). Furthermore, SCDs lend themselves to an in-depth exploration of process and outcome of therapy in applied settings, and, particularly when experimental, allows for drawing causal inferences about effectiveness. This is in line with the objectives of this study, which aims to answer questions about both outcomes and processes of change within NET.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottinghamshire Healthcare NHS Trust, Lincolnshire Partnership NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Thomas Schröder, PhD, Study director, University of NottinghamSarah Wilde, DClinPsy, Study director, University of LincolnFiammetta Rocca, Trainee Clinical Psychologist, MSc, Principal investigator, University of NottinghamNima Moghaddam, PhD, DClinPsy, Study director, University of Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866511
- Sponsor's protocol ID
- 21003
- Other IDs
- 291108
- Status last verified
- Jan 2023
- First submitted
- 22 Apr 2021
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neuner F, Catani C, Ruf M, Schauer E, Schauer M, Elbert T. Narrative exposure therapy for the treatment of traumatized children and adolescents (KidNET): from neurocognitive theory to field intervention. Child Adolesc Psychiatr Clin N Am. 2008 Jul;17(3):641-64, x. doi: 10.1016/j.chc.2008.03.001.
PubMed 18558317Schauer, M., Neuner, F., & Elbert, T. (2011). Narrative exposure therapy: A short-term treatment for traumatic stress disorders (2nd rev. and expanded ed.). Hogrefe Publishing.
Schauer, M., Neuner, F., & Elbert, T. (2017). Narrative Exposure Therapy for Children and Adolescents (KIDNET). In M. A. Landolt, M. Cloitre, & U. Schnyder (Eds.), Evidence-Based Treatments for Trauma Related Disorders in Children and Adolescents (pp. 227-250). Springer.
Parsonson, B. S., & Baer, D. M. (1986). The graphic analysis of data. In J. S. Bailey & M. R. Burch (Eds.), Research methods in applied behavior analysis (pp. 157-186). Springer.
Perrin, S., Meiser-Stedman, R., & Smith, P. (2005). The Children's Revised Impact of Event Scale (CRIES): Validity as a screening instrument for PTSD. Behavioural and Cognitive Psychotherapy, 33(4), 487-498.
Twigg, E., Barkham, M., Bewick, B. M., Mulhern, B., Connell, J., & Cooper, M. (2009). The Young Person's CORE: Development of a brief outcome measure for young people. Counselling and Psychotherapy Research, 9(3), 160-168.
Twigg E, Cooper M, Evans C, Freire E, Mellor-Clark J, McInnes B, Barkham M. Acceptability, reliability, referential distributions and sensitivity to change in the Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE) outcome measure: replication and refinement. Child Adolesc Ment Health. 2016 May;21(2):115-123. doi: 10.1111/camh.12128. Epub 2015 Nov 3.
PubMed 32680371Schafer SK, Ihmig FR, Lara H KA, Neurohr F, Kiefer S, Staginnus M, Lass-Hennemann J, Michael T. Effects of heart rate variability biofeedback during exposure to fear-provoking stimuli within spider-fearful individuals: study protocol for a randomized controlled trial. Trials. 2018 Mar 16;19(1):184. doi: 10.1186/s13063-018-2554-2.
PubMed 29548298Meiser-Stedman R, Smith P, Yule W, Dalgleish T. The Trauma Memory Quality Questionnaire: preliminary development and validation of a measure of trauma memory characteristics for children and adolescents. Memory. 2007 Apr;15(3):271-9. doi: 10.1080/09658210701256498.
PubMed 17454664Peltonen K, Kangaslampi S. Treating children and adolescents with multiple traumas: a randomized clinical trial of narrative exposure therapy. Eur J Psychotraumatol. 2019 Jan 17;10(1):1558708. doi: 10.1080/20008198.2018.1558708. eCollection 2019.
PubMed 30693077Isoaho, P., Kangaslampi, S., & Peltonen, K. (2015). Narratiivisen altistusterapian (NET) vaikutus kognitiivisiin prosesseihin ja mielenterveyteen: Tapaustutkimus = The effect of Narrative Exposure Therapy (NET) on cognitive processes and mental health: A case study. Psykologia, 50(5), 355-372. https://proxy.library.lincoln.ac.uk/login?url=https://search.ebscohost.com/login.aspx?direct=true&db=psyh&AN=2015-52491-003&site=ehost-live
Elliott, R., Slatick, E., & Urman, M. (2001). Qualitative Change Process Research on Psychotherapy: Alternative Strategies. Psychologische Beitrage, 43(3), 69-111.
Rocca F, Schroder T, Golijani-Moghaddam N, Wilde S. Video Narrative Exposure Therapy (NET) with Children and Young People who Witnessed Domestic Violence: A Naturalistic Single Case Study Series. J Child Adolesc Trauma. 2025 Jan 10;18(2):447-465. doi: 10.1007/s40653-024-00681-y. eCollection 2025 Jun.
PubMed 40469793
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Narrative Exposure Therapy (NET) With Children and Young People Who Witnessed Domestic Violence: A Naturalistic Single Case Study Series
- ClinicalTrials.gov ID
- NCT04866511
- Acronym / sponsor ID
- 21003
- Conditions
- Post-Traumatic Stress Disorder in Children, Post-Traumatic Stress Disorder in Adolescence, Post-Traumatic Stress Disorder Complex, Domestic Violence, Trauma, Psychological, Narrative Exposure Therapy
- Keywords
- post-traumatic stress, narrative exposure therapy, children and young people, domestic violence, case study series
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottinghamshire Healthcare NHS Trust, Lincolnshire Partnership NHS Foundation Trust
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 29 Apr 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.
Research suggests that children and young people (CYP) who witness domestic violence are susceptible to develop Post-traumatic stress (PTS). As their traumatic experiences are often repeated and prolonged, these CYP are likely to present with 'complex trauma' presentations, which also include other difficulties such as depressive symptoms and problems in functioning.
This study aims to investigate whether Narrative Exposure Therapy (NET) delivered via videoconferencing can be effective, feasible, and acceptable for CYP who witnessed domestic violence. NET is a brief, evidence-based intervention for complex trauma which has been adapted for CYP. The study will use a 'single case study series' design and look at whether NET can impact on PTS, psychological distress, and functioning. It will also look at the processes of change within NET and participants' experience of the therapy. Young people aged 12-17 who are experiencing PTS after exposure to domestic violence will be recruited from the waiting lists of Child and Adolescent Mental Health Services in Lincolnshire Partnership NHS Foundation Trust and Nottinghamshire Healthcare NHS Foundation Trust.
Up to six participants will receive six to ten weekly video sessions and the changes in the outcomes will be explored before, during and after NET. Finally, participants will be interviewed about their experiences.
The study is part of a Doctorate in Clinical Psychology programme and funded by Health Education England. Potential benefits include investigating NET with a new group, contributing to the research on complex trauma interventions for CYP, and providing insights on the effectiveness and acceptability of therapies via video.
Detailed description
The purpose of the study is to investigate the potential effectiveness, feasibility, acceptability and putative mechanisms of change of video NET with children and young people who witnessed domestic violence.
The primary objective of the study is to evaluate whether video NET can reduce PTS in this group.
The secondary objectives of the study are:
- To determine whether video NET can also impact on general psychological distress and functioning;
- To examine the putative mechanisms of change within NET, i.e. habituation and integration of trauma memories;
- To explore the feasibility and acceptability of video NET.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will adopt a Single Case Design (SCD) methodology, and specifically a naturalistic, sequential measurement, mixed-method AB design. SCDs are an idiographic method that allows for the analysis and interpretation of change at the level of the individual, rather the group. As such, SCDs typically aim to measure the change occurring in the individual's behaviour or symptoms by comparing the baseline, the intervention and the follow-up phases in terms of trends and variability (Parsonson \& Baer, 1986). Furthermore, SCDs lend themselves to an in-depth exploration of process and outcome of therapy in applied settings, and, particularly when experimental, allows for drawing causal inferences about effectiveness. This is in line with the objectives of this study, which aims to answer questions about both outcomes and processes of change within NET.
| Arm | Type | Receives |
|---|---|---|
| NET intervention | Experimental | Other: Narrative Exposure TherapyThis study will follow a single case design and will involve delivering and evaluating the child-friendly protocol of NET. Therefore, there will only be one arm (NET intervention) and no comparators. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Be aged 12- 17;
- Have witnessed domestic violence in the past;
- Be experiencing clinical levels of post-traumatic stress, as assessed by a member of the CAMHS team;
- Be on the waiting list to receive trauma-focused treatment;
- If 16 or over, be able to consent to take part, as assessed by a member of the CAMHS team;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Narrative Exposure TherapyAlso: NET, KIDNET (protocol for children and adolescents)NET is a trauma-focused psychological treatment for people who experienced multiple traumas (Schaeur et al., 2011). An adaptation named KIDNET was developed for use with children and young people (Neuner et al., 2008; Schauer et al., 2011, 2017). Participants will be offered 6-10 weekly sessions of NET lasting approximately 90 minutes each. The sessions will be delivered by a Trainee Clinical Psychologist via videoconferencing, in line with the UK's Government guidelines around reducing face-to-face contacts during the Covid-19 pandemic. | Other | NET intervention |
Primary outcome
Change in PTS symptoms between the baseline, NET intervention, and 1-month follow-up phases - as assessed by the Children's Revised Impact of Event Scale (CRIES-13; Perrin et al., 2005)
Time frame: Throughout the study, for approximately 18 weeks
The CRIES is a brief self-report questionnaire assessing PTS in children and young people aged 8-18. The original version of the scale (CRIES-8) includes 8 items evaluating intrusion and avoidance symptoms; a longer version (CRIES-13) comprising 5 additional items was developed to include the assessment of hyperarousal symptoms. The young person completing the scale is asked to rate each item depending on how frequently they experienced the symptom in the past week on a four-point scale . Although the CRIES is not a diagnostic instrument, higher scores suggest higher levels of PTS and likely clinical caseness. The scale has demonstrated good face and construct validity and has been used to screen and capture symptom change in children exposed to a variety of traumatic events (Perrin et al., 2005; Smith et al., 2003).
1 secondary outcome
Change in pyschological distress and functioning between the baseline, NET intervention, and 1-month follow-up phases - as assessed by the Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE; Twigg et al., 2009)
Time frame: Throughout the study, for approximately 18 weeks
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 19 Jan 2023.
- Background: PubMed 18558317Neuner F, Catani C, Ruf M, Schauer E, Schauer M, Elbert T. Narrative exposure therapy for the treatment of traumatized children and adolescents (KidNET): from neurocognitive theory to field intervention. Child Adolesc Psychiatr Clin N Am. 2008 Jul;17(3):641-64, x. doi: 10.1016/j.chc.2008.03.001.
- BackgroundSchauer, M., Neuner, F., & Elbert, T. (2011). Narrative exposure therapy: A short-term treatment for traumatic stress disorders (2nd rev. and expanded ed.). Hogrefe Publishing.
- BackgroundSchauer, M., Neuner, F., & Elbert, T. (2017). Narrative Exposure Therapy for Children and Adolescents (KIDNET). In M. A. Landolt, M. Cloitre, & U. Schnyder (Eds.), Evidence-Based Treatments for Trauma Related Disorders in Children and Adolescents (pp. 227-250). Springer.
- BackgroundParsonson, B. S., & Baer, D. M. (1986). The graphic analysis of data. In J. S. Bailey & M. R. Burch (Eds.), Research methods in applied behavior analysis (pp. 157-186). Springer.
- BackgroundPerrin, S., Meiser-Stedman, R., & Smith, P. (2005). The Children's Revised Impact of Event Scale (CRIES): Validity as a screening instrument for PTSD. Behavioural and Cognitive Psychotherapy, 33(4), 487-498.
- BackgroundTwigg, E., Barkham, M., Bewick, B. M., Mulhern, B., Connell, J., & Cooper, M. (2009). The Young Person's CORE: Development of a brief outcome measure for young people. Counselling and Psychotherapy Research, 9(3), 160-168.
- Background: PubMed 32680371Twigg E, Cooper M, Evans C, Freire E, Mellor-Clark J, McInnes B, Barkham M. Acceptability, reliability, referential distributions and sensitivity to change in the Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE) outcome measure: replication and refinement. Child Adolesc Ment Health. 2016 May;21(2):115-123. doi: 10.1111/camh.12128. Epub 2015 Nov 3.
- Background: PubMed 29548298Schafer SK, Ihmig FR, Lara H KA, Neurohr F, Kiefer S, Staginnus M, Lass-Hennemann J, Michael T. Effects of heart rate variability biofeedback during exposure to fear-provoking stimuli within spider-fearful individuals: study protocol for a randomized controlled trial. Trials. 2018 Mar 16;19(1):184. doi: 10.1186/s13063-018-2554-2.
- Background: PubMed 17454664Meiser-Stedman R, Smith P, Yule W, Dalgleish T. The Trauma Memory Quality Questionnaire: preliminary development and validation of a measure of trauma memory characteristics for children and adolescents. Memory. 2007 Apr;15(3):271-9. doi: 10.1080/09658210701256498.
- Background: PubMed 30693077Peltonen K, Kangaslampi S. Treating children and adolescents with multiple traumas: a randomized clinical trial of narrative exposure therapy. Eur J Psychotraumatol. 2019 Jan 17;10(1):1558708. doi: 10.1080/20008198.2018.1558708. eCollection 2019.
- BackgroundIsoaho, P., Kangaslampi, S., & Peltonen, K. (2015). Narratiivisen altistusterapian (NET) vaikutus kognitiivisiin prosesseihin ja mielenterveyteen: Tapaustutkimus = The effect of Narrative Exposure Therapy (NET) on cognitive processes and mental health: A case study. Psykologia, 50(5), 355-372. https://proxy.library.lincoln.ac.uk/login?url=https://search.ebscohost.com/login.aspx?direct=true&db=psyh&AN=2015-52491-003&site=ehost-live
- BackgroundElliott, R., Slatick, E., & Urman, M. (2001). Qualitative Change Process Research on Psychotherapy: Alternative Strategies. Psychologische Beitrage, 43(3), 69-111.
- Individual participant dataSharing planned: No
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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.
Thomas Schröder, PhD study director
University of Nottingham
Sarah Wilde, DClinPsy study director
University of Lincoln
Fiammetta Rocca, Trainee Clinical Psychologist, MSc principal investigator
University of Nottingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Exposure Therapy in people with Post-Traumatic Stress Disorder in Children and Post-Traumatic Stress Disorder in Adolescence, run by University of Nottingham at 2 sites in United Kingdom.
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 13 inclusion and 0 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 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Change in PTS symptoms between the baseline, NET intervention, and 1-month follow-up phases - as assessed by the Children's Revised Impact of Event Scale (CRIES-13; Perrin et al., 2005) (time frame: Throughout the study, for approximately 18 weeks). 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 NCT04866511, which also lists 13 linked publications.
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 19 Jan 2023.