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The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a Treatment for Traumatized Young Refugees versus Treatment as Usual: A Multi-Center Randomized Controlled Trial

The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a Treatment for Traumatized Young Refugees versus Treatment as Usual: A Multi-Center Randomized Controlled Trial - YOURTREAT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017222
Enrollment
80
Registered
2019-05-15
Start date
2019-06-27
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Interventions

Group 1: Narrative Exposure Therapy for Children (KIDNET), 11 sessions Group 2: Treatment as Usual (TAU) within the German Health System

Sponsors

Universität Bielefeld
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: • being a refugee allocated to the community close to one of the participating centers but not necessarily with a permanent permit to stay • PTSD diagnosis according to CAPS-CA-5 • Age 10-18 years • Informed consent obtained from participant (if participant is =16) or participant and caregiver/legal guardian (if participant is <16)

Exclusion criteria

Exclusion criteria: • Acute risk of harm of self or others requiring inpatient treatment • Clinical signs of acute psychotic disorder • Clinical signs of mental retardation which would prevent effective psychotherapy • Concurrent psychotherapeutic treatment • Anxiolytic treatment with benzodiazepines as this medication is known to interfere with exposure-based psychotherapy (other medication is allowed and will be monitored). • High alcohol or drug consumption (= 2-3 days of consumption per week) represents an exclusion criterion if participants cannot assure their preparedness and confidence to control their consumption in favor of the treatment they will receive in the framework of the trial

Design outcomes

Primary

MeasureTime frame
The change in PTSD symptom severity from the diagnostic interview before treatment initiation to the follow-up assignments after 6 and 12 months. PTSD symptoms will be measured at each assessment by a structured clinical interview by expert clinicians using the Clinician-Administered PTSD Scale for DSM-5 – Child/Adolescent Version (CAPS-CA-5; Pynoos et al., 2015). The change in PTSD Symptoms will be evaluated by a mixed linear model.

Secondary

MeasureTime frame
The following continuous secondary outcomes will be assessed before treatment (baseline) and at each follow-up assessment (after 6 and 12 months). The change of these secondary outcomes will be also evaluated by mixed linear models. (1) Depressive symptoms and internalizing and externalizing behavior, assessed by the Hopkins symptom checklist-37 for refugee adolescents (HSCL-37A; Bean, Derluyn, Eurelings-Bontekoe, Broekaert, & Spinhoven, 2007), (2) Suicidal ideation, assessed by the Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011), and (3) Physical health, assessed by 17 items selected from the Screening for Somatoform Symptoms 7 (SOMS-7) based on their frequency and sensitivity to change (Rief & Hiller, 2003). In addition, the rate of participants who still meet the diagnostic criteria of PTSD according to the CAPS-CA-5, as well as the PTSD response rate will be assessed at each follow-up assessment (after 6 and 12 months). The PTSD response rate will be defined as the number of participants who show clinical significant symptom improvement on the CAPS-CA5, according to the reliable change index (RCI).

Countries

Germany

Contacts

Public ContactSarah Wilker

Universität Bielefeld

sarah.wilker@uni-bielefeld.de+49 521 106-4489

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 28, 2026