Video NET With CYP Who Witnessed Domestic Violence

Sponsor

University of Nottingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04866511

Collaborator

Nottinghamshire Healthcare NHS Trust (Other), Lincolnshire Partnership NHS Foundation Trust (Other)

Enrollment

Arm

10.1

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Stress Disorder in Children Post-Traumatic Stress Disorder in Adolescence Post-Traumatic Stress Disorder Complex Domestic Violence Trauma, Psychological Narrative Exposure Therapy	Other: Narrative Exposure Therapy	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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)

Primary Purpose:

Treatment

Official Title:

Video Narrative Exposure Therapy (NET) With Children and Young People Who Witnessed Domestic Violence: A Naturalistic Single Case Study Series

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Narrative Exposure Therapy 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: NET KIDNET (protocol for children and adolescents)

Arm

Intervention/Treatment

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.

Other: Narrative Exposure Therapy

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:

NET

KIDNET (protocol for children and adolescents)

Outcome Measures

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) [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).

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) [Throughout the study, for approximately 18 weeks]
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).

Other Outcome Measures

Process measure of habituation: Heart Rate (HR) wristband monitor [For approximately 10 weeks]
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.
Process measure of integration of trauma memories: Trauma Memory Quality Questionnaire (TMQQ; Meiser-Stedman et al. 2007) [Approximately 10 weeks]
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).
Change interviews [At 1-month follow-up]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Nottingham
Nottinghamshire Healthcare NHS Trust
Lincolnshire Partnership NHS Foundation Trust

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