F41 F32 F43 F33 F40
Conditions
Interventions
Group 1: In this subproject no interventions will be performed.
Analyses of data from a randomized controlled trial will be conducted exclusively.
For information on the intervention, please see: DRK
Sponsors
Universitätsklinikum Hamburg-Eppendorf Institut für Gesundheitsökonomie und Versorgungsforschung
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Refugee parents (2) child(ren) aged 0-6 years (3) Arabic, German or Englisch language skills (4) meeting clinical cut-off on Depression Anxiety Stress Scales (DASS-21)
Exclusion criteria
Exclusion criteria: Key exclusion criteria: (1) other primary mental health problems (2) concurrent psychotherapy (3) (instable) intake of relevant medication (neuroleptic drugs, instable anticholinergic, or instable antiepileptic drugs) (4) acute psychosis (5) acute suicidality (6) general medical contraindications Comorbid mental health problems are not a criterion for exclusion as long as they are not primary.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes are the ICER and CEAC based on direct health care costs of parents and children as well as the QALY of the parents. -Direct health care costs: modified version of the Client Sociodemographic and Service Receipt Inventory (CSSRI), original version by Chisholm et al (2000), german version by Roick et al (2001). The questionnaire in this study is based on the German version. Monetary valuation of resource utilization is based on the standardized valuation set by Bock et al (2015). -Quality of life assessment for QALY calculation: EQ-5D-5L, original version by Herdman et al (2011). In this study, we use the official German translation by the EuroQol group. For the valuation of health states we use the German value set calculated by Ludwig, von der Schulenburg und Greiner (2018). All primary outcomes will be assessed pre, and at 6- and 12-months follow-up. The analysis is based on the 12-month total costs and QALY. We will use analytical approaches appropriate for the distribution of the data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are days without mental health burden. Mental health burden of parents and children will be assessed by group-specific instruments. Parents: Depression Anxiety and Stress Scale (DASS-21): Original version by Lovibond and Lovibond (1995), German short version by Nilges and Essau (2015), Arabic version by Moussa, Lovibond, Laube, and Megahead (2017). Children: SDQ-P (Strengths and Difficulties Questionnaire): Original version by Goodman (1994), German version by Klasen et al. (2005), Arabic version by Alyahri et al. (2005); Alyahri and Goodman (2006). The analysis is based on days without mental health burden after 12 months. Days without mental health burden will be calculated based on the method by Lave, Frank, Schulberg and Kamlet (1998). We will use analytical approaches appropriate for the distribution of the data. | — |
Countries
Germany
Contacts
Public ContactKerstin Konietzny
Ruhr-Universität Bochum Forschungs- und Behandlungszentrum für psychische Gesundheit (FBZ) Klinische Kinder- und Jugendpsychologie Fakultät für Psychologie
Outcome results
None listed