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Video NET With CYP Who Witnessed Domestic Violence

Primary Purpose

Post-Traumatic Stress Disorder in Children, Post-Traumatic Stress Disorder in Adolescence, Post-Traumatic Stress Disorder Complex

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Narrative Exposure Therapy
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder in Children focused on measuring post-traumatic stress, narrative exposure therapy, children and young people, domestic violence, case study series

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lincolnshire Partnership Foundation NHS Trust - Child and Adolescent Mental Health Services
  • Nottinghmashire Healthcare NHS Foundation Trust - Community Child and Adolescent Mental Health Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NET intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
April 22, 2021
Last Updated
January 18, 2023
Sponsor
University of Nottingham
Collaborators
Nottinghamshire Healthcare NHS Trust, Lincolnshire Partnership NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04866511
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
March 11, 2022 (Actual)
Study Completion Date
April 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
Nottinghamshire Healthcare NHS Trust, Lincolnshire Partnership NHS Foundation Trust

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NET intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Narrative Exposure Therapy
Other Intervention Name(s)
NET, KIDNET (protocol for children and adolescents)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
Throughout the study, for approximately 18 weeks
Secondary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
Throughout the study, for approximately 18 weeks
Other Pre-specified Outcome Measures:
Title
Process measure of habituation: Heart Rate (HR) wristband monitor
Description
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.
Time Frame
For approximately 10 weeks
Title
Process measure of integration of trauma memories: Trauma Memory Quality Questionnaire (TMQQ; Meiser-Stedman et al. 2007)
Description
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).
Time Frame
Approximately 10 weeks
Title
Change interviews
Description
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.
Time Frame
At 1-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Schröder, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sarah Wilde, DClinPsy
Organizational Affiliation
University of Lincoln
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fiammetta Rocca, Trainee Clinical Psychologist, MSc
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nima Moghaddam, PhD, DClinPsy
Organizational Affiliation
University of Lincoln
Official's Role
Study Director
Facility Information:
Facility Name
Lincolnshire Partnership Foundation NHS Trust - Child and Adolescent Mental Health Services
City
Lincoln
State/Province
Lincolnshire
ZIP/Postal Code
LN5 7RZ
Country
United Kingdom
Facility Name
Nottinghmashire Healthcare NHS Foundation Trust - Community Child and Adolescent Mental Health Services
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 3FL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18558317
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
32680371
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.
Results Reference
background
PubMed Identifier
29548298
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.
Results Reference
background
PubMed Identifier
17454664
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.
Results Reference
background
PubMed Identifier
30693077
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.
Results Reference
background
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
Results Reference
background
Citation
Elliott, R., Slatick, E., & Urman, M. (2001). Qualitative Change Process Research on Psychotherapy: Alternative Strategies. Psychologische Beitrage, 43(3), 69-111.
Results Reference
background

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Video NET With CYP Who Witnessed Domestic Violence

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