Exploratory Randomized Controlled Trial of a Psychoeducational Add-On Intervention for Identifying and Discussing Negative Effects of Outpatient Psychotherapy in Children and Adolescents

INTERVENTION: Group 1: Early Add‐On Intervention Group: Participating patients receive the psychoeducational add‐on intervention (AOI) immediately after the baseline assessment at T1. The AOI is delivered once during a regularly scheduled outpatient psychotherapy session and lasts approximately 50 minutes. As part of the AOI, treating therapists use a structured workbook to provide participating patients with age‐appropriate psychoeducation about potential negative effects and side effects of psychotherapy. The workbook is based on the Inventory for the Assessment of Negative Effects of Psychotherapy in Children and Parents (Kinder‐INEP; Bieda et al., 2018). The closed‐ended questions and predefined response scales included in the workbook were taken from the Kinder‐INEP. The workbook is completed jointly by the patient and the treating therapist. Potential negative or burdensome effects of the treatment received to date are systematically identified, evaluated regarding their possible attribution to psychotherapy, and discussed together. Regular outpatient psychotherapy continues unchanged throughout the study period. Further questionnaire assessments are conducted two week after the AOI at T2 and four weeks after the AOI at T3. Group 2: Delayed Add‐On Intervention/Waiting Control Group: Between T1 and T2, participating patients continue to receive their regular outpatient psychotherapy but do not yet receive the AOI. During this two‐week period, Arm 2 serves as the delayed‐intervention or waiting‐control group. At T2 (two weeks after T1), the pre‐intervention assessment is conducted first. Immediately afterwards, participating patients receive the same single AOI as Arm 1 during a regularly scheduled outpatient psychotherapy session. The AOI lasts no longer than 50 minutes. As part of the AOI, treating therapists use the structured workbook to provide participating patients with age‐appropriate psychoeducation about potential negative effects and side effects of psychotherapy. The workbook is completed jointly by the patient and the treating therapist. Potential negative or burdensome effects of the treatment received to date are systematically identified, evaluated regarding their possible attribution to psychotherapy, and discussed together. Regular outpatient psychotherapy continues unchanged throughout the study period. The final questionnaire assessment is conducted two weeks after the AOI at T3 (four weeks after T1). CONDITION: ; F00‐F99 Mental and behavioural disorders INCLUSION CRITERIA: ‐ Patients' age between 11 years 0 months and 18 years 11 months at the time of enrollment ‐ Currently receiving outpatient psychotherapy in the Outpatient Psychotherapy Unit at the Department of Clinical Child and Adolescent Psychology and Psychotherapy at Trier University, Germany, with usually weekly scheduled therapy sessions ‐ The patient and treating therapist have completed at least 10 psychotherapy sessions together before study enrollment ‐ Written informed consent of the treating therapist ‐ Written informed consent of the patient ‐ From patients who are under 15 years of age: Additional written informed consent of the legal guardian(s) whose consent is required under the ethics approval and applicable legal requirements PRIMARY OUTCOME: Patient‐rated Therapeutic Alliance:; The therapeutic alliance is assessed using the patient‐rated version of the Relationship Questionnaire for Child and Adolescent Psychotherapy (BeKi; Kinnen et al., 2011). The BeKi is the German adaption of the Therapeutic Alliance Scale for Children (TASC; Kronmüller et al., 2003; Shirk & Saiz, 1992). Only the patient‐rated version of the BeKi (BeKi‐KJ) is used in this study because the primary outcome concerns the therapeutic alliance from the patients' perspective (child/adolescents). The BeKi‐KJ comprises 15 items rated on a 4‐point Likert scale. It assesses the three dimensions of the therapeutic alliance: therapy motivation, therapeutic working relationship, and compliance/expectations of therapeutic success. Assessments are conducted immediately before the respective psychotherapy session at:; ‐ T1: baseline before the AOI in Arm 1; ‐ T2 (two weeks after T1): two weeks after the AOI in Arm 1 and before the AOI in Arm 2; ‐ T3 (four weeks after T1): four weeks after the AOI in Arm 1 and two weeks after the AOI in Arm 2; The primary exploratory outcome is the difference between the Early Add‐On Intervention Group (Arm 1) and the Delayed Add‐On Intervention/Waiting Control Group (Arm 2) in the change in the BeKi‐KJ total score (change in therapeutic alliance) from T1 to T2. SECONDARY OUTCOME: a) Self‐Efficacy: ; General self‐efficacy is assessed using the patient‐rated German version of the General self‐Efficacy Scale (SWE; Schwarzer & Jerusalem, 1999). The SWE comprises 10 items rated on a 4‐point Likert scale. The SWE assesses the patients' belief in their ability to cope effectively with difficult situations and successfully accomplish tasks. Higher scores indicate greater perceived general self‐efficacy. Assessments are conducted immediately before the respective psychotherapy session at T1, T2 (two weeks after T1) and T3 (four weeks after T1). The main exploratory outcome is the difference between the Early Add‐On Intervention Group (Arm 1) and the Delayed Add‐On Intervention/Waiting Control Group (Arm 2) in the change in the SWE total score (change in self‐efficacy) from T1 to T2. ; ; b) Acceptability and Satisfaction: ; Acceptability of and satisfaction with the AOI are assessed immediately after the AOI using a patient‐rated questionnaire scale developed specifically for this study. The questionnaire comprises 12 items. Item 1‐10 are rated on a 5‐point Likert scale, while item 11‐12 are qualitative items with an open‐ended response format. The questionnaire assesses patients' perspective on the comprehensibility, perceived usefulness, acceptability, and negative aspects of the workbook and, consequently, of the AOI. The assessment is conducted: ; ‐ in Arm 1 immediately after the AOI at T1 ; ‐ in Arm 2 immediately after the AOI at T2 ; Results will be evaluated descriptively using item responses, scale scores, means, standard deviations, frequencies, and proportions. ; ; c) Treatment Integrity: ; Treatment integrity and adherence to the AOI protocol are assessed immediately after the AOI using a therapist‐rated questionnaire developed specifically for this study. ; The questionnaire comprises 13 items. Item 1‐11 are rated on a 7‐point Likert scale, while item 12‐13 are qualitative items with an open‐ended response format. The questionnaire assesses three aspects of treatment integrity: treatment adherence, treatment competence, and treatment differentiation. The assessment is conducted: ; ‐ in Arm 1 immediately after the AOI at T1 ; ‐ in Arm 2 immediately after the AOI at T2 ; Treatment integrity will be evaluated as an intervention‐fidelity or process measure rather than as a patient treatment outcome. ; ; d) Number and Type of Negative Effects and Side Effects of Psychotherapy: ; The number and type of negative effects identified during the AOI, as well as their attribution as side effects of psychotherapy, are assessed using the structured documentation included in the workbook and completed during the AOI. ; Negative effects are recorded as unwanted or burdensome experiences, irrespective of whether they are attributed to the psychotherapy. In addition, the workbook documents whether the respective negative effects are considered by the patient‐therapist dyad to be causally attributable to the psychotherapy and are therefore classified as side effects of psychotherapy.