Please select the outcome measures that correspond to the clinical trial below.
Title: RISE- Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test and Extend Parenting for Lifelong Health - A Factorial Study (Phase 2 of MOST)
Brief Summary: The aim of this study is to optimize an adapted version of a parenting program, Parenting for Lifelong Health for Young Children (PLH), to meet the specific needs of families in three low- and middle-income countries in Southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova) using a cluster factorial experimental design to select the most efficacious, cost-effective, and scalable intervention components. This study is the second phase of a three-phase research project (www.rise-plh.eu).

The cluster factorial experiment will examine the effectiveness, cost-effectiveness, and implementation of three selected components of the PLH for Children program to inform the selection of the most effective, cost-effective, and implementable components to include in a prevention package prior to testing it in a subsequent RCT. The cluster factorial experiment will be conducted across three Southeastern European country sites. Each site will recruit families with children aged two to nine years who have elevated levels of child behavior problems, including specifically high-risk groups, such as minorities (e.g. Roma families). Program facilitators will be recruited from local agencies and schools. The factorial experimental trial will randomize 16 clusters in each country to one of 8 experimental conditions which consist of any combination of the three components (program length: 5 sessions/10 sessions; engagement booster: high/low; fidelity booster: high supervision/low supervision). The purpose of this factorial experiment is to estimate the main effects of the three intervention components and interactions between the components.

At the end of the cluster factorial experiment, we will develop an optimized version of the program by selecting components or component levels that have the highest level of effectiveness as based on effect size (rather than p-values). We will also take into consideration factors regarding cost-effectiveness and implementation outcomes when designing this optimized intervention package.


Options:
A: Change in level of aggressive behaviour in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, sub-scale "Aggressive behaviour" (from the Externalizing Scale) (pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)); Change in frequency of dysfunctional parenting: Parenting Scale (PS) / self-report (shortened version); total score (pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)); Change in frequency of positive parenting and effective discipline: Parenting of Young Children Scale (PARYC) / self-report (21 items); continuous total score (pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020))
B: School Climate (Up to 7 months)
C: depression (On completion of intervention and six months post-intervention)
D: Change in COVID-19 knowledge (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey); Change in COVID-19 protective behaviors (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey); Change in depressive symptoms (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey); Change in anxiety symptoms (Baseline survey, 2-week post-intervention survey, and 2-month post-intervention survey)

Answer: A