Unerwünschte Nebenwirkungen in der Kinder- und Jugendlichenpsychotherapie – Eine Einführung und Empfehlungen

Bieda, Angela; Pflug, Verena; Scholten, Saskia; Lippert, Michael W.; Ladwig, Inga; Nestoriuc, Yvonne; Schneider, Silvia

doi:10.1055/s-0044-102291

Cited by 16 publications

(6 citation statements)

References 29 publications

(28 reference statements)

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“…One welcome recent development in relation to assessment of negative effects of psychological interventions has been the construction of standardized scales to measure these (e.g. Bieda et al, 2018; Ladwig et al, 2014; Rozental et al, 2019), analogous to the measures of side-effects long used within pharmacological trials. While these scales need to be interpreted in the context of other data collected during the trial (e.g.…”

Section: Discussionmentioning

confidence: 99%

Making the leap: From experimental psychopathology to clinical trials

Blackwell

Woud

2022

Journal of Experimental Psychopathology

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One important aim of experimental psychopathology research is to inform development of new interventions derived from basic science. However, testing whether a newly developed intervention is in fact effective requires moving from experimental studies to clinical trials, and this transition can pose many problems. These problems stem not only from the inherent complexity of even the simplest clinical trial but also from differences between experimental psychopathology and clinical trial research that may not always be obvious to researchers immersed in only one of these specialist areas. In this paper, we explore some of these complexities and discuss when a clinical trial may, or may not, be the best next step in the translational process. We then consider some of the ins and outs of clinical trials methodology, from design and planning through to reporting, with the aim of providing a guide for experimental psychopathology researchers thinking of making the leap from their experimental studies of mechanisms to clinical trials of novel interventions. We hope that this can help increase the chance of successful clinical translation and novel treatment development from basic science.

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Section: Discussionmentioning

confidence: 99%

Making the leap: From experimental psychopathology to clinical trials

Blackwell

Woud

2022

Journal of Experimental Psychopathology

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“…The Children-INEP consists of 18 items to asses unwanted side effects of psychotherapy via caregiver report [31].…”

Section: Methodsmentioning

confidence: 99%

Evaluation of “Cognitive Behavioral Intervention for Trauma in Schools” (CBITS) in child welfare programs in Germany: Study Protocol of a Randomized Controlled Trial

Pfeiffer,

Dörrie,

Köksal

et al. 2024

Preprint

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Background Children and adolescents growing up in child welfare institutions have been frequently exposed to traumatic events, psychosocial stress and show elevated rates of mental disorders. Yet there is a lack of empirically supported treatments to provide adequate mental health care for children in care suffering from trauma-related mental disorders such as posttraumatic stress disorder (PTSD), depression and anxiety. The Cognitive Behavioral Intervention for Trauma in Schools (CBITS) is an evaluated trauma-focused cognitive-behavioral group intervention, which has proven to be effective in reducing symptoms of PTSD, depression and anxiety for traumatized children in group settings. The trial will evaluate effectiveness of the CBITS intervention as an outreach treatment compared with an enhanced treatment as usual condition (TAU+) within the German mental health and child welfare system. Methods In a randomized controlled trial (RCT) involving N = 90 children and adolescents, we will compare CBITS with TAU+. Participants between 8–16 years, reporting at least one traumatic event and moderate Posttraumatic Stress Symptoms (PTSS) will be randomized within their child welfare institution to either one of the conditions using a CATS-2 severity stratified block randomization. Assessments will take place at baseline, as well as 4 months and 10 months after baseline. The primary outcome is the severity of PTSS after 4 months. Secondary outcomes are depression, anxiety, irritability/anger, quality of life and global functioning level. Discussion The results of our trial will provide evidence regarding effective treatment options for traumatized children in care, which represent an understudied population with limited access to mental health care. Additionally, it could serve as blueprint for implementing trauma-focused outreach group treatments for children in care and increase the accessibility to appropriate treatment. Trial registration Clinical Trials.gov, ID: NCT06038357 D. Registered on ClinicalTrials.gov public website. URL: https://classic.clinicaltrials.gov/ct2/show/NCT06038357?cond=NCT06038357&draw=2&rank=1

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“…The “Inventory for the Assessment of Negative Effects of Psychotherapy for Children and Adolescents” (Children-INEP) consists of 18 items which assess unwanted side effects of the therapy [ 31 ].…”

Section: Methodsmentioning

confidence: 99%

“…The Children-INEP consists of 18 items to assess unwanted side effects of psychotherapy via caregiver report [ 31 ].…”

Section: Methodsmentioning

confidence: 99%

Evaluation of “Cognitive Behavioral Intervention for Trauma in Schools” (CBITS) in child welfare programs in Germany: study protocol of a randomized controlled trial

Pfeiffer,

Dörrie,

Köksal

et al. 2024

Trials

View full text Add to dashboard Cite

Background Children and adolescents growing up in child welfare institutions have been frequently exposed to traumatic events and psychosocial stress and show elevated rates of mental disorders. Yet, there is a lack of empirically supported treatments to provide adequate mental health care for children in care suffering from trauma-related mental disorders such as posttraumatic stress disorder (PTSD), depression, and anxiety. The Cognitive Behavioral Intervention for Trauma in Schools (CBITS) is an evaluated trauma-focused cognitive-behavioral group intervention, which has proven to be effective in reducing symptoms of PTSD, depression, and anxiety for traumatized children in group settings. The trial will evaluate the effectiveness of the CBITS intervention as an outreach treatment compared with an enhanced treatment-as-usual condition (TAU +) within the German mental health and child welfare system. Methods In a randomized controlled trial (RCT) involving N = 90 children and adolescents, we will compare CBITS with TAU + . Participants between 8 and 16 years, reporting at least one traumatic event and moderate posttraumatic stress symptoms (PTSS), will be randomized within their child welfare institution to either one of the conditions using a CATS-2 severity-stratified block randomization. Assessments will take place at baseline, as well as 4 months and 10 months after baseline. The primary outcome is the severity of PTSS after 4 months. Secondary outcomes are depression, anxiety, irritability/anger, quality of life, and global functioning level. Discussion The results of our trial will provide evidence regarding effective treatment options for traumatized children in care, which represent an understudied population with limited access to mental health care. Additionally, it could serve as a blueprint for implementing trauma-focused outreach group treatments for children in care and increase the accessibility to appropriate treatment. Trial registration Clinical Trials.gov NCT06038357 D. September 13, 2023.

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Unerwünschte Nebenwirkungen in der Kinder- und Jugendlichenpsychotherapie – Eine Einführung und Empfehlungen

Cited by 16 publications

References 29 publications

Making the leap: From experimental psychopathology to clinical trials

Making the leap: From experimental psychopathology to clinical trials

Evaluation of “Cognitive Behavioral Intervention for Trauma in Schools” (CBITS) in child welfare programs in Germany: Study Protocol of a Randomized Controlled Trial

Evaluation of “Cognitive Behavioral Intervention for Trauma in Schools” (CBITS) in child welfare programs in Germany: study protocol of a randomized controlled trial

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