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Completed

NCT Number: NCT04866511

Video NET With CYP Who Witnessed Domestic Violence

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.

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Key information

Conditions

Post-Traumatic Stress Disorder in Children Domestic Violence Mental Disorders Narrative Exposure Therapy Post-Traumatic Stress Disorder Complex Post-Traumatic Stress Disorder in Adolescence Psychological Trauma Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Psychological

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lincolnshire Partnership Foundation NHS Trust - Child and Adolescent Mental Health Services, Lincoln, Lincolnshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Narrative Exposure Therapy

Other

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)

Primary outcomes

  1. 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).

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)

    Time frame: 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 outcomes

  1. Process measure of habituation: Heart Rate (HR) wristband monitor

    Time frame: 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.

  2. Process measure of integration of trauma memories: Trauma Memory Quality Questionnaire (TMQQ; Meiser-Stedman et al. 2007)

    Time frame: 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).

  3. Change interviews

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

  • Lincolnshire Partnership NHS Foundation Trust
  • Nottinghamshire Healthcare NHS Trust

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2021
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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