- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04866511
Video NET With CYP Who Witnessed Domestic Violence
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lincolnshire
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Lincoln, Lincolnshire, United Kingdom, LN5 7RZ
- Lincolnshire Partnership Foundation NHS Trust - Child and Adolescent Mental Health Services
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG5 3FL
- Nottinghmashire Healthcare NHS Foundation Trust - Community Child and Adolescent Mental Health Services
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria - Participants must:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: NET intervention
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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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).
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Throughout the study, for approximately 18 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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).
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Throughout the study, for approximately 18 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Process measure of habituation: Heart Rate (HR) wristband monitor
Time Frame: For approximately 10 weeks
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HR monitors have been recommended for use as a proxy measure of physiological arousal (Schäfer et al., 2018).
In the proposed study, changes in HR will be used to measure: a) within-session habituation (WSH) before and after exposure to traumatic narratives; b) and between-session habituation (BSH) as the narration progresses.
Commercially available monitors include chest straps and wristbands; the latter type was deemed less invasive for participants and thus chosen for this study.
Huawei Band 4 Pro is an example of a wearable activity tracker that includes a continuous heart rate monitor function.
The product can be connected with the manufacturer's app (Huawei Health) installed on an Android or IOS mobile device.
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For approximately 10 weeks
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Process measure of integration of trauma memories: Trauma Memory Quality Questionnaire (TMQQ; Meiser-Stedman et al. 2007)
Time Frame: Approximately 10 weeks
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The TMQQ is an 11-item self-report questionnaire designed to assess the problematic characteristics of traumatic memories resulting from a lack of autobiographical integration (e.g.
fragmentation, sensory/visual rather than verbal quality etc.) in children and young people.
The young person rates the item on a 4-point scale (1 = "Don't agree at all", 2 = "Don't agree a bit", 3 = "Agree a bit", 4 = "Completely agree") how well the statements reflect their trauma memories.
Higher scores are indicative of more problematic and less integrated memories.
The scale has been previously employed to measure the impact of NET on the quality of traumatic memories (Peltonen & Kangaslampi, 2019; Isoaho et al., 2015).
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Approximately 10 weeks
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Change interviews
Time Frame: At 1-month follow-up
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The feasibility and acceptability of video NET will be investigated by conducting Change Interviews with the young people approximately one month after completing the treatment.
In this instance, the young people will also be asked to provide feedback on their experience of receiving treatment via videoconferencing, including in terms of barriers and fascinators to engagement.
The interviews will be conducted by an external researcher, i.e. another Trainee Clinical Psychologist, following an adaptation of Elliott, Slatick, & Urman's (2001) protocol.
The interviews will be audio- or video-recorded and then sent to the student/investigator for transcription and analysis.
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At 1-month follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Thomas Schröder, PhD, University of Nottingham
- Study Director: Sarah Wilde, DClinPsy, University of Lincoln
- Principal Investigator: Fiammetta Rocca, Trainee Clinical Psychologist, MSc, University of Nottingham
- Study Director: Nima Moghaddam, PhD, DClinPsy, University of Lincoln
Publications and helpful links
General 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.
- Schauer, 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.
- Schafer 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.
- Meiser-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.
- Peltonen 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.
- Isoaho, 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21003
- 291108 (Other Identifier: IRAS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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