NCT06934109

Brief Summary

The goal of this naturalistic single case series design is to investigate if an adapted Narrative Exposure Therapy protocol can be effective, is feasible, and acceptable for adults with a mile learning disability. Participants will be complete three baseline sessions before taking part in Narrative Exposure Therapy using a manual that has been adapted for people with a learning disability. Trauma symptoms will be measured weekly using the Impact of Events scale adapted for intellectual disabilities. The person's carer will also complete an informant scale related to these symptoms (LANTS-IV). The client will also complete the CORE-LD at pre, and post therapy. Six weeks after the end of the intervention, the client and their carer will be invited to a feedback session to talk about how they found the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 29, 2026

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

February 26, 2025

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Impact of Events Scale for intellectual disabilities (IES-ID)

    The IES-ID (Hall et al., 2014) is a 22 item scale scored on a three-point Likert scale measuring trauma related symptoms. This is an adapted measure that has been validated for people with an intellectual disability.

    Completed weekly through baseline and intervention stages, approximately 16 weeks. Then at 6-week follow up (approximately week 22).

  • Lancaster and Northgate Trauma Scale for Intellectual Disabilities - Informant Version (LANTS-IV; Wigham et al., 2011)

    47 scored on a six-point scale for frequency and three-point for severity.

    Completed weekly through baseline and intervention stages, approximately 16 weeks. Then at 6-week follow up (approximately week 22).

  • Clinical Outcome Routine Evaluation-Learning Disabilities (CORE-LD; Brooks et al., 2013)

    14 scored on a three-point Likert scale measuring psychological distress across four domains: well-being, symptoms, functioning, and risk

    At baseline week 1 and at 6-week follow-up (approximately week 22).

  • Change interview (Elliott et al., 2001) with clients and carers

    A feedback session will be held with the client and their carer around 6-weeks after the therapy has come to an end. This will ask for feedback on how they found the intervention.

    6-weeks post-intervention. Sessions will be around 30-60 minutes.

Secondary Outcomes (2)

  • Heart rate

    Weekly during the intervention sessions, for approximately 12-weeks.

  • Post-session therapist reflections

    Across the intervention phase, an average of a year

Study Arms (1)

Narrative Exposure Therapy treatment

EXPERIMENTAL

All participants within the trial will receive narrative exposure therapy and be within the treatment arm.

Other: Narrative Exposure Therapy (NET)

Interventions

NET is a psychological talking therapy that has been designed for people who have experienced multiple and prolonged traumatic experiences. It is typically 12-sessions, involving first a psychoeducation session, then laying a lifeline where stones are lain to represent traumatic events, and flowers positive life events. The following sessions the person is asked to talk through their life, going into detail on the traumatic memories that they have experienced.

Narrative Exposure Therapy treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and over
  • Meet the criteria for having a mild ID as assessed by a clinical psychologist within the team
  • English speaking
  • Have capacity to consent
  • The participant must be experiencing trauma related stress as assessed by themselves, the clinical psychologist and the research team
  • Be able to travel to one of the therapy sites
  • Carer participant must have ability to reflect and comment on the trauma related stress experienced by the client participant
  • Carer must also be 18 years old or older and be English speaking.
  • Carer must have known participant for 1 year or more.

You may not qualify if:

  • They are substance dependent
  • They are currently receiving another trauma-focused intervention
  • Currently an inpatient
  • Carers excluded if they lack capacity to consent to take part in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, NG3 6AA, United Kingdom

Location

MeSH Terms

Conditions

Psychological TraumaLearning DisabilitiesStress Disorders, Post-TraumaticIntellectual DisabilityLymphoma, Follicular

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Thomas Schroder

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 26, 2025

First Posted

April 18, 2025

Study Start

December 3, 2024

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

April 29, 2026

Record last verified: 2025-01

Locations