Clinical trial NCT04866511: Video NET With CYP Who Witnessed Domestic Violence
Official title: Video Narrative Exposure Therapy (NET) With Children and Young People Who Witnessed Domestic Violence: A Naturalistic Single Case Study Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nottinghamshire Healthcare NHS Trust
name: Lincolnshire Partnership NHS Foundation Trust
First posted: 2021-04-29
Enrollment: 5
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
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)
timeFrame: Throughout the study, for approximately 18 weeks
Secondary outcomes:
measure: 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)
timeFrame: Throughout the study, for approximately 18 weeks
Other outcomes:
measure: Process measure of habituation: Heart Rate (HR) wristband monitor
timeFrame: For approximately 10 weeks
measure: Process measure of integration of trauma memories: Trauma Memory Quality Questionnaire (TMQQ; Meiser-Stedman et al. 2007)
timeFrame: Approximately 10 weeks
measure: Change interviews
timeFrame: At 1-month follow-up
Locations:
city: Lincoln
country: United Kingdom
facility: Lincolnshire Partnership Foundation NHS Trust - Child and Adolescent Mental Health Services
state: Lincolnshire
city: Nottingham
country: United Kingdom
facility: Nottinghmashire Healthcare NHS Foundation Trust - Community Child and Adolescent Mental Health Services
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Thomas Schröder, PhD
role: STUDY_DIRECTOR
affiliation: University of Lincoln
name: Sarah Wilde, DClinPsy
role: STUDY_DIRECTOR
affiliation: University of Nottingham
name: Fiammetta Rocca, Trainee Clinical Psychologist, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lincoln
name: Nima Moghaddam, PhD, DClinPsy
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: Elliott, R., Slatick, E., & Urman, M. (2001). Qualitative Change Process Research on Psychotherapy: Alternative Strategies. Psychologische Beitrage, 43(3), 69-111.