Please select the arm or intervention descriptions that belong 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: Arm Label: Length: long; Engagement booster: high; Fidelity booster: high; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: long; Engagement booster: high; Fidelity booster: low; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: long; Engagement booster: low; Fidelity booster: high; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: long; Engagement booster: low; Fidelity booster: low; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: short; Engagement booster: high; Fidelity booster:high; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: short; Engagement booster: high; Fidelity booster: low; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: short; Engagement booster: low; Fidelity booster: high; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Arm Label: Length: short; Engagement booster: low; Fidelity booster: low; Type: EXPERIMENTAL; Interventions: Behavioral: Parenting for Lifelong Health (PLH) | Intervention Type: BEHAVIORAL; Name: Parenting for Lifelong Health (PLH); Assigned to Arm(s): Length: long; Engagement booster: high; Fidelity booster: high, Length: long; Engagement booster: high; Fidelity booster: low, Length: long; Engagement booster: low; Fidelity booster: high, Length: long; Engagement booster: low; Fidelity booster: low, Length: short; Engagement booster: high; Fidelity booster: low, Length: short; Engagement booster: high; Fidelity booster:high, Length: short; Engagement booster: low; Fidelity booster: high, Length: short; Engagement booster: low; Fidelity booster: low
B: Arm Label: TSM arm; Type: EXPERIMENTAL; Interventions: Behavioral: SEHER Intervention delivered by TSM, Behavioral: Tarang AEP | Arm Label: SM arm; Type: EXPERIMENTAL; Interventions: Behavioral: SEHER Intervention delivered by SM, Behavioral: Tarang AEP | Arm Label: Comparison arm Tarang AEP; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Tarang AEP | Intervention Type: BEHAVIORAL; Name: SEHER Intervention delivered by TSM; Assigned to Arm(s): TSM arm | Intervention Type: BEHAVIORAL; Name: SEHER Intervention delivered by SM; Assigned to Arm(s): SM arm | Intervention Type: BEHAVIORAL; Name: Tarang AEP; Assigned to Arm(s): Comparison arm Tarang AEP, SM arm, TSM arm
C: Arm Label: advocacy intervention; Type: EXPERIMENTAL; Interventions: Behavioral: advocacy intervention | Arm Label: Usual community services; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: usual community services | Intervention Type: BEHAVIORAL; Name: advocacy intervention; Assigned to Arm(s): advocacy intervention | Intervention Type: BEHAVIORAL; Name: usual community services; Assigned to Arm(s): Usual community services
D: Arm Label: Immediate; Type: EXPERIMENTAL; Interventions: Behavioral: eHealth for Covid-19 prevention and support | Arm Label: Waitlist; Type: OTHER; Interventions: Behavioral: eHealth for Covid-19 prevention and support | Intervention Type: BEHAVIORAL; Name: eHealth for Covid-19 prevention and support; Assigned to Arm(s): Immediate, Waitlist

Answer: A