Implementation and evaluation of family-based interventions within the Germany-wide Children of Mentally Ill Parents-network: study protocol for three prospective, rater-blinded, cluster-randomized controlled multicenter trials.
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Paumen Theresa, Leidger Anna, Ralfs Joana, Modarressi Anna, Ozga Ann-Kathrin, Möhl Annika, Daubmann Anne, Zapf Antonia, Waldmann Tamara, von Gottberg Carolin, Kilian Reinhold, Pardey Nicolas, Zeidler Jan, Beeker Timo, von Peter Sebastian, Heinze Martin, Pawils Silke, Georg Anna K, Taubner Svenja, Piwkowska Olga, Winter Sibylle M, Lingnau Ruth, Stammann Carina, Willms Gerald, Rezvani Farhad, Dirmaier Jörg, Sekler Koralia, Görres Birgit, Gallinat Jürgen, Lambert Martin, Hohmann Sarah, Driessen Martin, Siniatchkin Michael, Jessen Frank, Bender Stephan, Bermpohl Felix, Heinz Andreas, Correll Christoph U, Rummel-Kluge Christine, Seidl Ulrich W, Möhler Eva, Domschke Katharina, Fleischhaker Christian, Jäger Markus, Noterdaeme Michele, Guderian Frank, Jarczok Tomasz Antoni, Kölch Michael, Burghardt Roland, Kronmüller Klaus-Thomas, Klein Fabian, Holtmann Martin, Fallgatter Andreas J, Renner Tobias J, Schulte-Körne Gerd, Platt Belinda, Frodl Thomas, Flechtner Hans-Henning, Haase Christian, Mehl Stephanie, Becker Katja, Claus Sylvia, In-Albon Tina, Schlößer Ralf, Englert Ekkehart, Becker Thomas, Reif Andreas, Berner Michael, Born Simone, Bottlender Meike, Marschall Ursula, Schäfer Luisa, Rocabado Sophia, Krull Thomas, Henkel Michél, Brinkmann Alice, Lübke Jana, Plachetka Heike, Hüttmann Steve, Brandt Florian, Wiegand-Grefe Silke
Аннотация
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.
CLINICAL TRIAL REGISTRATION: https://www.bfarm.de/DE/Das-BfArM/Aufgaben/Deutsches-Register-Klinischer-Studien/_node.html; DRKS00020380; https://www.clinicaltrials.gov: NCT04369625.