Trial document




drksid header

  DRKS00017453

Trial Description

start of 1:1-Block title

Title

Improving mental health care for unaccompanied young refugees through a stepped care approach

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

BETTER CARE

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://bettercare.ku.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Young refugees show high rates of psychological distress and several international studies have pointed out that their need for professional mental health care is high. However, in many care systems they do not regularly receive the appropriate treatment for their psychological needs. In this study, we aim to develop and implement a new stepped-care system for young refugees ("BETTER CARE") and examine whether participants allocated to this system show higher symptom improvement than participants in the usual care system. In order to investigate this research question, we will recruit 540 young refugees residing in southern Germany and randomly assign them to two groups, whereby one half will receive BETTER CARE and the other half will receive usual care. Twelve months after the initial assignment, we will evaluate whether participants in the BETTER CARE system show less Posttraumatic Stress Symptoms, higher quality of life, and whether they will have received individual psychotherapy more frequently than the comparison group in the usual care system. In doing so, we aim to contribute to enhancing the mental health care for this vulnerable group.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The overarching goal is to implement a stepped-care approach ("BETTER CARE"), consisting of screening, prevention and individual psychotherapy, in order to offer empirically supported trauma-informed interventions for unaccompanied young refugees (UYRs). Within the model BETTER CARE, we will implement two interventions:

1) A preventive group intervention called ‘Mein Weg’ (engl. ‘My Way’; (Pfeiffer & Goldbeck, 2019)) delivered in the residential facilities of the participants by trained and supervised social workers for UYRs with subclinical posttraumatic stress symptoms (PTSS).
2) The evidence-based trauma-focused cognitive behavioral therapy (TF-CBT; Cohen, 2017) for UYRs with clinically relevant PTSS, delivered in clinical practice by trained psychotherapists with the optional involvement of trained interpreters.

In a cluster-randomized controlled trial, BETTER CARE will be compared to the usual care system (complemented with screening and treatment recommendation, “USUAL CARE+”) regarding mental health outcomes, the costs of care for UYRs and the cost-utility of BETTER CARE. The implementation of the group intervention into the residential facilities of the UYRs and the implementation of TF-CBT into community clinical practice will be evaluated regarding treatment fidelity, outcome, and number of treated cases.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

Data sharing is possible after application and agreement from all partners.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017453
  •   2019/12/11
  •   [---]*
  •   yes
  •   Approved
  •   243/19, Ethik-Kommission der Universität Ulm
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   DSM-5: Posttraumatic Stress Disorder
  •   F43.1 -  Post-traumatic stress disorder
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   BETTER CARE. Stepped-care approach, consisting of:

    1) Screening of psychological symptoms.

    2) 7 to 9 sessions of "Mein Weg" (Pfeiffer & Goldbeck, 2019), a group prevention program delivered in the residential facilities of the UYRs (unaccompanied young refugees) by trained caregivers for participants with subclinical PTSS.

    3) Up to 18 sessions of TF-CBT (trauma-focused cognitive behavioral therapy) (Cohen, 2017) delivered by residential child and youth psychotherapists for participants with clinically significant symptoms.

    Participants can switch from one condition to another based on the course of their symptoms.
  •   USUAL CARE+ (Control group). Current care system in Germany including an initial screening of psychological symptoms and treatment recommendation. Premised on the screening, participating facilities and UYRs (unaccompanied young refugees) receive a short report with treatment recommendation. Other than that, facilities that are randomized into the USUAL CARE+ condition will follow their usual procedures (e.g. referral to medical practicioners, contacting psychotherapists etc.).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Severity of PTSS, assessed with the Child and Adolescent Trauma Screen 2 (CATS-2), 12 months after randomization.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

1) Severity of depressive symptoms, assessed with the Patient Health Questionnaire (PHQ-9), 12 months after randomization.
2) Severity of anxiety symptoms, assessed with the Generalized Anxiety Disorder (GAD-7), 12 months after randomization.
3) Quality of life, assessed with the World Health Organization Quality of Life, brief version (WHOQOL-BREF), 12 months after randomization.
4) Severity of PTSS, assessed with the CAT-2 caregiver report, 12 months after randomization.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2020/01/07
  •   540
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   20   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Inclusion criteria for this study are two-fold.

A) At the level of the participating facilities (i.e., residential groups where UYRs are residing)
1) At least 8 UYRs residing in the facility at intake, 2) Willingness to training and implementation of the screening, 3) Willingness to appoint a mental health coordinator within the facility, 4) Willingness to implement ‘Mein Weg’ within the facility, 5) In case of referral of UYRs to TF-CBT, willingness to send a caregiver for participation in TF-CBT, 6) At least one eligible therapist per 10 UYRs available in the vicinity (not more than 1 hour travel time).

B) At the level of the participating UYRs:
1) Age 12 to 20 years, 2) Unaccompanied, 3) Applied for asylum in Germany or planning on doing so, 4) Living in residential care provided by a facility of the Child and Youth Welfare System (CYWS), 5) Informed consent given (by UYRs and legal guardians in case of minors), 6) Report of at least one traumatic experience in the initial screening (CATS-2).

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

At the level of CYWS facilities:

1) No previous participation in "Mein Weg" studies (Pfeiffer & Goldbeck, 2017; Pfeiffer et al., 2018).

There are no exclusion criteria at the level of the participating UYRs.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Katholische Universität Eichstätt-Ingolstadt
    • Ms.  Prof. Dr.  Garbiele  Gien 
    • Ostenstraße 26
    • 85072  Eichstätt
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Universität UlmKlinik für Kinder- und Jugendpsychiatrie/Psychotherapie
    • Ms.  Prof. Dr.  Ute  Ziegenhain 
    • Steinhövelstraße 5
    • 89075  Ulm
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Deutsches Jugendinstitut
    • Mr.  Dr.  Heinz  Kindler 
    • Nockherstraße 2
    • 81541  München
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Klinik für Psychiatrie und Psychotherapie II der Universität Ulm am Bezirkskrankenhaus Günzburg
    • Mr.  Prof. Dr.  Reinhold  Kilian 
    • Ludwig-Heilmeyer-Str.
    • 89312  Günzburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Katholische Universität Eichstätt-Ingolstadt Lehrstuhl für Klinische und Biologische Psychologie
    • Ms.  Prof. Dr.  Rita  Rosner 
    • Ostenstr. 25
    • 85072  Eichstätt
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Katholische Universität Eichstätt-Ingolstadt Lehrstuhl für Klinische und Biologische Psychologie Psychotherapeutische Hochschulambulanz
    • Ms.  Dr.  Johanna  Unterhitzenberger 
    • Levelingstr. 7
    • 85049  Ingolstadt
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.