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A randomized, waiting list controlled, multi-center study to evaluate START (Stress-Trauma Symptoms-Arousal-Regulation-Treatment) training for young refugees with traumatic stress related disorders

A randomized, waiting list controlled, multi-center study to evaluate START (Stress-Trauma Symptoms-Arousal-Regulation-Treatment) training for young refugees with traumatic stress related disorders - Start A1 for adolescents

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00020771
Enrollment
174
Registered
2020-04-21
Start date
2020-10-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

F43.1

Interventions

Group 1: Intervention group: manualized training program twice a week for 60 min over eight weeks, 90 min booster session four weeks later Group 2: Waiting control group

Sponsors

Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 17 Years

Inclusion criteria

Inclusion criteria: Symptoms of post-traumatic stress disorder (ETI-KJ: a total of at least 16 points in the items of re-experience, avoidance and hyperarousal); CGI-S >= 4; non-verbal IQ >= 70; sufficient reading ability and language comprehension in at least one of the languages German, English, Dari, Arabic, Somali, Russian or Ukrainian; education and written consent of both the patient and his legal representative before study specific measures be implemented

Exclusion criteria

Exclusion criteria: Current harmful use or Substance dependence (diagnosis in kiddie- Schedule for Affective Disorders and Schizophrenia, Present and Lifetime (K-SADS-PL) and positive saliva drug test for questionable substance); Current alcohol dependency (Alcohol Use Disorders Identification Test (AUDIT) > 8P); Assured diagnosis of a severe psychiatric disorder (using K-SADS-PL); Acute suicidal tendency (based on the Columbia-Suicide Severity Rating Scale (C-SSRS)); Acute external hazard (based on the diagnostic Foreign Hazard Sheet); change in psychopharmacological Treatment within two weeks before baseline; Current weekly psychotherapy; Inpatient

Design outcomes

Primary

MeasureTime frame
Pre-post difference after eight weeks of therapy of PSS-10 (Perceived Stress Scale) and IES-R (Impact of Event Scale - Revised)

Secondary

MeasureTime frame
Stability of the treatment effect (PSS-10 [Perceived Stress Scale] and IES-R [Impact of Event Scale - Revised] after 12 weeks and after 24 weeks); Emotional regulation (DERS-18 - Difficulties in Emotion Regulation Scale); trauma symptoms (cPTCI - Difficulties in Emotion Regulation Scale, ETI-KJ - Essen trauma inventory for children and adolescents, CATS-2 - Child and Adolescent Trauma Screen-2); Nightmares (DDNSI - Disturbing Dream and Nightmare Severity Index); General Psychopathology and Psychosocial Functional Level (CGI-S - Clinical Global Impression Scale - Severity of Illness, SDQ- strengths and Difficulties Questionnaire), BDI-II - Beck Depression Inventory)) Analysis of drop-outs (Drop-Out Conditions (PMLD)); Neuroendocrine stress markers (hair cortisol analysis to baseline, after 12 weeks of therapy and after 12 weeks of follow-up)

Countries

Germany

Contacts

Public ContactBianca Brückner

Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und -psychotherapie

bianca.brueckner@unimedizin-mainz.de+49 (0)6131 17 - 3281

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 13, 2026