NCT04866511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

April 22, 2021

Last Update Submit

January 18, 2023

Conditions

Keywords

post-traumatic stressnarrative exposure therapychildren and young peopledomestic violencecase study series

Outcome Measures

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)

    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).

    Throughout the study, for approximately 18 weeks

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)

    Throughout the study, for approximately 18 weeks

Other Outcomes (3)

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

    For approximately 10 weeks

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

    Approximately 10 weeks

  • Change interviews

    At 1-month follow-up

Study Arms (1)

NET intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: NET, KIDNET (protocol for children and adolescents)
NET intervention

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lincolnshire Partnership Foundation NHS Trust - Child and Adolescent Mental Health Services

Lincoln, Lincolnshire, LN5 7RZ, United Kingdom

Location

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

Nottingham, Nottinghamshire, NG5 3FL, United Kingdom

Location

Related Publications (13)

  • 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.

    PMID: 18558317BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32680371BACKGROUND
  • 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.

    PMID: 29548298BACKGROUND
  • 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.

    PMID: 17454664BACKGROUND
  • 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.

    PMID: 30693077BACKGROUND
  • 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

    BACKGROUND
  • Elliott, R., Slatick, E., & Urman, M. (2001). Qualitative Change Process Research on Psychotherapy: Alternative Strategies. Psychologische Beitrage, 43(3), 69-111.

    BACKGROUND
  • Rocca F, Schroder T, Golijani-Moghaddam N, Wilde S. Video Narrative Exposure Therapy (NET) with Children and Young People who Witnessed Domestic Violence: A Naturalistic Single Case Study Series. J Child Adolesc Trauma. 2025 Jan 10;18(2):447-465. doi: 10.1007/s40653-024-00681-y. eCollection 2025 Jun.

MeSH Terms

Conditions

Psychological Trauma

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Thomas Schröder, PhD

    University of Nottingham

    STUDY DIRECTOR
  • Sarah Wilde, DClinPsy

    University of Lincoln

    STUDY DIRECTOR
  • Fiammetta Rocca, Trainee Clinical Psychologist, MSc

    University of Nottingham

    PRINCIPAL INVESTIGATOR
  • Nima Moghaddam, PhD, DClinPsy

    University of Lincoln

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 29, 2021

Study Start

April 13, 2021

Primary Completion

March 11, 2022

Study Completion

April 11, 2022

Last Updated

January 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations