Progress feedback in children and adolescents with internalizing and externalizing symptoms in routine care (OPTIE study): study protocol of a randomized parallel-group trial.

BACKGROUND: Progress feedback provides therapists with progress notes on a regular basis through the continuous assessment of participants throughout their treatment (e.g., symptoms, therapeutic alliance). While for adults the evidence base has increased over the years, progress feedback in the therapy of children and adolescents has not been sufficiently investigated. This manuscript describes the trial protocol of the OPTIE study: a randomized trial that tests the efficacy of a progress feedback system in children and adolescents under conditions of routine care. METHODS: The study is based on a randomized parallel-group trial with two treatment groups (routine, feedback) at an outpatient unit of a university hospital. The target sample size is 439 families consisting of children and adolescents aged 6 to17 years old with internalizing and/or externalizing symptoms. Both the patients and the therapists are independently assigned to the treatment groups by stratified block randomization. In both treatment groups patients receive routine care behavioral therapy for a study-related 12 months; additionally, in the feedback group, a progress feedback system with three components is applied (monitoring, report, and supervision). For three informants (caregiver, child [≥ 11 years], therapist) surveys are conducted every 6 weeks (e.g., symptoms, goals, motivation). For both treatment groups, comparison data is collected at baseline and at six and 12 months after the beginning of the intervention (pre, inter, post), and includes five informants (blinded clinician, therapist, caregiver, child [≥ 11 years], teacher). DISCUSSION: The OPTIE study will contribute to the evidence base of progress feedback in children and adolescents and has the potential to uncover treatments' effects in the small to medium range. Noteworthy features are the inclusion of children younger than 10 years old and the consideration of a blinded clinician rating. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00016737 ( https://www.drks.de/DRKS00016737 ). Registered 17 September, 2019.

A semi-structured interview for the dimensional assessment of internalizing and externalizing symptoms in children and adolescents: Interview Version of the Symptoms and Functioning Severity Scale (SFSS-I).

BACKGROUND: This study evaluates the psychometric properties of the newly developed semi-structured interview, Interview Version of the Symptoms and Functioning Severity Scale (SFSS-I), which is designed to provide a dimensional assessment of internalizing and externalizing symptoms. METHODS: Multi-informant baseline data from the OPTIE study was used, involving 358 children and adolescents aged 6 to 17 years (M = 11.54, SD = 3.4, n = 140 [39.1%] were female). Participants were screened for internalizing and externalizing symptoms. For validity analyses, caregiver (Child Behavior Checklist), youth (Youth Self Report), and teacher ratings (Teacher Report Form) were used. We performed Receiver Operating Characteristic (ROC) analyses to evaluate the effectiveness of the SFSS-I subscales in distinguishing between children and adolescents diagnosed with internalizing and externalizing disorders, as determined by clinical judgement in routine care. RESULTS: Confirmatory factor analyses supported a correlated two-factor model for internalizing and externalizing symptoms. Acceptable to good internal consistencies (α = 0.76 to 0.89; ω = 0.76 to 0.90) and excellent interrater reliability on the scale level (ICC ≥ 0.91) was found. The ROC analyses showed an acceptable accuracy in identifying internalizing diagnoses (AUC = 0.76) and excellent accuracy for externalizing diagnoses (AUC = 0.84). CONCLUSION: The SFSS-I demonstrates potential as a clinically-rated instrument for screening and routine outcome monitoring, offering utility in both clinical practice and research settings for the dimensional assessment of broad psychopathological dimensions. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00016737 ( https://www.drks.de/DRKS00016737 ). Registered 17 September, 2019.