Implementation and evaluation of family-based interventions within the Germany-wide Children of Mentally Ill Parents (CHIMPS)-Network: Study protocol for three prospective, rater-blinded, cluster-randomized controlled multicenter trials

Theresa Paumen^1*Anna Leidger¹Joana Ralfs¹Anna Modarressi¹Ann-Kathrin Ozga²Annika Möhl²Anne Daubmann²Antonia Zapf²Tamara Waldmann³Carolin von Gottberg⁴Reinhold Kilian⁴Nicolas Pardey⁵Jan Zeidler⁵Timo Beeker⁶Sebastian von Peter⁶Martin Heinze⁶Silke Pawils⁷Anna Katharina Georg^8,9Svenja Taubner^10,8Olga Piwkowska¹¹Sibylle M. Winter^10,11Ruth Lingnau¹²Carina Stammann¹²Gerald Willms¹²Farhad Rezvani⁷Jörg Dirmaier⁷Koralia Sekler¹³Birgit Görres¹⁴Jürgen Gallinat¹Prof. Dr. Martin Lambert¹Sarah Hohmann¹⁵Martin Driessen¹⁶Michael Siniatchkin^17,18Frank Jessen¹⁹Stephan Bender²⁰Felix Bermpohl²¹Andreas Heinz²²Christoph U. Correll¹¹Christine Rummel-Kluge²³Ulrich W. Seidl²⁴Eva Möhler²⁵Katharina Domschke^10,26Christian Fleischhaker²⁷Markus Jäger²⁸Michele Noterdaeme²⁹Frank Guderian²⁹Tomasz Antoni Jarczok³⁰Michael Kölch³¹Roland Burghardt^32,33Klaus-Thomas Kronmüller³⁴Fabian Klein³⁴Martin Holtmann³⁵Andreas J Fallgatter^36,37Tobias Johann Renner³⁸Gerd Schulte-Körne³⁹Belinda Platt³⁹Thomas Frodl⁴⁰Henning Flechtner⁴¹Christian Haase⁴²Stephanie Mehl⁴³Katja Becker⁴⁴Sylvia Claus⁴⁵Tina In-Albon^46,47Ralf Schlößer⁴⁸Ekkehart Englert⁴⁹Thomas Becker⁵⁰Andreas Reif⁵¹Michael Berner⁵²Simone Born⁵²Meike Bottlender⁵³Ursula Marschall⁵⁴Luisa Schäfer⁵⁵Sophia Rocabado⁵⁶Thomas Krull⁵⁷Michél Henkel⁵⁸Alice Brinkmann⁵⁸Jana Lübke⁵⁹Heike Plachetka⁶⁰Steve Hüttmann⁶¹Florian Brandt⁶²Silke Wiegand-Grefe^1,63*

• ¹Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
• ²Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
• ³University of Ulm, Department of Psychiatry II, Section: Health Economics and Health Services Research, Bezirkskrankenkaus Günzburg, Günzburg, Germany
• ⁴University of Ulm, Department of Psychiatry II, Section: Health Economics and Health Services Research, Bezirkskrankenhaus Günzburg, Günzburg, Germany
• ⁵Center for Health Economics Research Hannover (CHERH), Leibniz University Hannover, Hanover, Germany
• ⁶Center for Mental Health, Immanuel Klinik Rüdersdorf, University Hospital of Brandenburg Medical School Theodor Fontane, Rüdersdorf, Germany
• ⁷Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
• ⁸Institute for Psychosocial Prevention, Center for Psychosocial Medicine, University Hospital Heidelberg, Heidelberg, Germany
• ⁹Clinical Psychology and Psychotherapy of Childhood and Adolescence, University of Tübingen, Tübingen, Germany
• ¹⁰German Center for Mental Health (DZPG), Berlin, Germany
• ¹¹Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Charité - Universitätsmedizin Berlin, Berlin, Germany
• ¹²Department of Evaluation and Implementation Research, aQua Institute for Applied Quality Improvement and Research in Health Care GmbH, Göttingen, Germany
• ¹³AFET Federal Association for Educational Assistance, Registered Association, Hanover, Germany
• ¹⁴Community Psychiatry Umbrella Organization, Registered Association, Cologne, Germany
• ¹⁵Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
• ¹⁶Evangelisches Klinikum Bethel gGmbH, Department of Psychiatry and Psychotherapy, University Medical Center OWL, Bielefeld University, Bielefeld, Germany
• ¹⁷University Clinic for Child and Adolescent Psychiatry and Psychotherapy, Protestant Hospital Bethel, University Clinics OWL, Bielefeld, Germany
• ¹⁸Clinic of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Aachen, RWTH Aachen University, Aachen, Germany
• ¹⁹Department of Psychiatry, Medical Faculty, University of Cologne, Cologne, Germany
• ²⁰Faculty of Medicine and University Hospital Cologne, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Cologne, Cologne, Germany
• ²¹Department of Psychiatry and Psychotherapy, Charité Campus St. Hedwig Hospital, Berlin, Germany
• ²²Department of Psychiatry and Psychotherapy, Charité Campus Mitte, Charité Universitätsmedizin Berlin, Berlin, Germany
• ²³Department of Psychiatry and Psychotherapy, Medical Faculty, Leipzig University, Leipzig, Germany
• ²⁴Department of Psychiatry and Psychotherapy, SHG-Kliniken Saarbrücken, Saarbrücken, Germany
• ²⁵Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Saarland University Medical Center, Homburg, Germany
• ²⁶Department of Psychiatry and Psychotherapy, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
• ²⁷Department of Child and Adolescent Psychiatry and Psychotherapy, University medical center Freiburg, Freiburg, Germany
• ²⁸Department of Psychiatry, Psychotherapy and Psychosomatic, District Hospital Kempten, Kempten, Germany
• ²⁹Department of Child and Adolescent Psychiatry and Psychotherapy, KJF Klinik Josefinum, Augsburg, Germany
• ³⁰Department of Child and Adolescent Psychiatry and Psychotherapy, KJP Klinik Josefinum, Augsburg, Germany
• ³¹Department of Child and Adolescent Psychiatry, Neurology, Psychosomatics and Psychotherapy, Rostock University Medical Center, Rostock, Germany
• ³²Department of Child and Adolescent Psychiatry, Klinikum Frankfurt/Oder, Frankfurt an der Oder, Germany
• ³³Child and Adolescent Psychiatry, Oberberg Klinik Fasanenkiez, Berlin, Germany
• ³⁴Department of General Psychiatry and Psychotherapy, Landschaftsverband Westfalen-Lippe (LWL) Hospital Gütersloh, Gütersloh, Germany
• ³⁵LWL-University Hospital for Child and Adolescent Psychiatry, Ruhr-University Bochum, Hamm, Germany
• ³⁶Department of Psychiatry and Psychotherapy, University Hospital of Tübingen, Tübingen, Germany
• ³⁷German Center for Mental Health (DZPG), Partner Site Tübingen, Tübingen, Germany
• ³⁸Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University, University Hospital of Psychiatry and Psychotherapy, Tübingen, Germany
• ³⁹Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, LMU University Hospital, LMU Munich, Munich, Germany
• ⁴⁰Department of Psychiatry and Psychotherapy and Center for Behavioral Brain Sciences, Otto von Guericke University of Magdeburg, Magdeburg, Germany
• ⁴¹Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany
• ⁴²Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Helios Clinics Schwerin, Schwerin, Germany
• ⁴³Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior, University of Marburg (Philipps Universität), Marburg, Germany
• ⁴⁴Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital of Marburg and University of Marburg (Philipps Universität), Marburg, Germany
• ⁴⁵Department of Psychiatry, Psychosomatics und Psychotherapy, Pfalzklinikum, Klingenmünster, Germany
• ⁴⁶Clinical Child and Adolescent Psychology and Psychotherapy, University of Kaiserslautern-Landau, Landau, Germany
• ⁴⁷Clinical Child and Adolescent Psychology and Psychotherapy, University of Mannheim, Mannheim, Germany
• ⁴⁸Clinic for Psychiatry, Psychotherapy and Psychosomatics, Helios Hospital Erfurt, Erfurt, Germany
• ⁴⁹Clinic for Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, Helios Hospital Erfurt, Erfurt, Germany
• ⁵⁰Department of Psychiatry II, Ulm University, Ulm, Germany
• ⁵¹Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Goethe University Frankfurt, Frankfurt am Main, Germany
• ⁵²Psychiatry and Psychotherapeutic Medicine, Municipal Clinical Center of Karlsruhe, Karlsruhe, Germany
• ⁵³Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Municipal Clinical Center of Karlsruhe, Karlsruhe, Germany
• ⁵⁴Statutory Health Insurance, BARMER, Wuppertal, Germany
• ⁵⁵Statutory Health Insurance, Techniker Krankenkasse, Hamburg, Germany
• ⁵⁶Statutory Health Insurance, DAK-Gesundheit, Hamburg, Germany
• ⁵⁷Statutory Health Insurance, Mobil Krankenkasse, Celle, Germany
• ⁵⁸Statutory Health Insurance, KKH Kaufmännische Krankenkasse, Hanover, Germany
• ⁵⁹Statutory Health Insurance, AOK Baden-Württemberg, Stuttgart, Germany
• ⁶⁰Statutory Health Insurance, AOK - Die Gesundheitskasse in Hessen, Bad Homburg, Germany
• ⁶¹Statutory Health Insurance, IKK classic, Dresden, Germany
• ⁶²Statutory Health Insurance, IKK Südwest, Saarbrücken, Germany
• ⁶³The German Center for Child and Adolescent Health (DZKJ), Hamburg, Germany

Introduction: Children of mentally ill parents have an increased risk of developing a mental illness. From an ethical and health-economic perspective, psychotherapeutic care for this risk group is necessary to counter the risk of transgenerational transmission of mental illness. The psychosocial situation of affected families is complex and requires customized support. Within the Children-of-Mentally-Ill-Parents-Network (CHIMPS-NET), three family-based, needs-tailored new forms of care (NFC) – based on the manualized CHIMPS intervention – are implemented and evaluated at 21 locations in Germany. The online intervention iCHIMPS is described in a separate study protocol. Methods: For each NFC, a prospective, rater-blinded, cluster-randomized, controlled study is conducted. Data is collected from the perspective of both parents, all children aged 8 years and older, external raters and therapists at four measurement points: at baseline (T1) and 6 (T2), 12 (T3) and 18 (T4) months after randomization. Allocation to the respective trials is based on baseline assessments of children’s mental health symptoms/diagnoses and family functionality, which is followed by randomization. We hypothesize that children in the intervention groups (IGs) have fewer parent-reported mental health problems at T3 than in the respective control groups (CGs), which receive Treatment-as-Usual (TAU). The biometric effect evaluation is supplemented by health economic evaluations and a qualitative evaluation. Discussion: CHIMPS-NET has both raised awareness for children of mentally ill parents and enabled various stakeholders to network with each other. The network contributes to evidence-based care for this risk group. An update of the CHIMPS manual regarding the customized NFC is in process.