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Prevention of child mental health problems in Southeastern Europe - Adapt, Optimize, Test, and Extend Parenting for Lifelong Health

Periodic Reporting for period 2 - RISE (Prevention of child mental health problems in Southeastern Europe - Adapt, Optimize, Test, and Extend Parenting for Lifelong Health)

Reporting period: 2019-07-01 to 2020-12-31

The aim of RISE is to address the urgent need for effective and affordable programs targeted at preventing child mental health problems in low- and middle-income countries (LMICs), and in particular, Southeastern Europe. Early intervention is one of the key strategies for the effective prevention of mental health problems in children and adolescents and has the potential to reduce later mental health problems. Furthermore, in order to prevent the development of child mental health problems in LMIC, low cost efforts are needed in countries where there are limited human and financial resources. The primary objective of the study is to conduct a series of studies to develop, optimize and test the Parenting for Lifelong Health’s (PLH) program for families with children ages 2 to 9 years (PLH 2-9) in Romania, North Macedonia, and Republic of Moldova. Therefore, we aim to a) adapt and implement a low-cost parenting program to reduce risk for child behavioral disorders in these three countries, b) optimize the PLH 2-9 intervention package across the three countries using a factorial experimental design to select the components, which are most efficacious, cost-effective and scalable, and c) test the optimized intervention package in a multi-site randomized controlled trial (RCT) across the three countries. A secondary objective of this project is to carefully assess barriers to implementation, integration with existing service delivery systems, and scale-up from the outset to facilitate sustainability and real-world applicability at the end of the project. Thus, we aim to a) determine the economic impacts of PLH 2-9 and the potential costs of future dissemination and scale-up taking into account barriers and equity in three Southeastern European countries, b) systematically evaluate key barriers and facilitators at the local, national and international levels that impact prevention of child behavioral disorders, c) identify and address socioeconomic and contextual factors in regions of Republic of Moldova, North Macedonia, and Romania that influence adaptation and implementation of PLH 2-9, and d) develop strategies to embed the intervention into practice and policy to sustain the intervention after the end of the project by working with various stakeholders from each country throughout the project and taking into consideration contextual factors and barriers to scaling up (e.g. stigma, accessibility).
During the first 36 months of the project, management procedures were successfully implemented, project finances managed, and Executive Board Meetings as well as Steering Committee Meetings completed on a regular basis. In total, 16 deliverables were submitted and 4 milestones successfully achieved. Adherence to ethical guidelines and EU regulations was closely monitored and ensured. An ethical application and subsequent amendments for the overall study were submitted and approved by the responsible ethics committees.

In Phase 1 of the study, a qualitative study was conducted in each country with officials, experts and practitioners in the public health and welfare fields in order to identify implementation factors and program adaptation requirements necessary to deliver an evidence informed parenting intervention to reduce risk for behavioral disorders in children and improve parenting practice. After gathering input from Parenting Experts Working Groups in each country, the PLH 2-9 program content, process, and structure were adapted so that they are appropriate to the cultural context and the capacity for service delivery in North Macedonia, Republic of Moldova, and Romania. The adapted PLH 2-9 program was tested in a feasibility pilot to examine implementation fidelity, program acceptability, measurement applicability, and preliminary effectiveness. Measure selection and qualitative and quantitative data collection was successfully completed for Study Phase 1. Data analyses for Phase 1 were also conducted.

In Phase 2 of the study (Optimization study), participants were successfully recruited and randomized to 8 experimental conditions in each country. Based on results from the feasibility study, the following intervention components were identified for testing during the factorial experiment based on our conceptual model: length (5 vs. 10 sessions), engagement (basic vs. enhanced package), and fidelity (on-demand vs. structured supervision). The Intervention was successfully implemented across sites. All data assessments for Phase 2 and Health Economic Analyses of Phase 2 were successfully completed. A Data management plan was developed and is followed ever since.

Due to COVID-19 restrictions, implementation strategies for Phase 3 were carefully adapted to ensure safety of staff and participants while still fulfilling the tasks outlined in the Grant Agreement. A stepwise safety plan with COVID-19 related precautions was developed. Recruitment of Phase 3 is currently ongoing.

Results of Phase 1 and preliminary results of Phase 2 were presented at internal and external scientific meetings. Three peer-revied manuscripts were published. Further manuscripts on findings of Phase 1 and Phase 2 are currently in preparation. Several conference presentations of preliminary study results were given and abstracts for conferences were submitted. A project website (http://www.rise-plh.eu/) was developed and is delivering information about the intervention and translations of the program, information about all WPs and the project team. Contact has already been established within countries with policy makers within each country.
To date, we have successfully achieved the following impact: (1) adapted the program based on stakeholder feedback related to context of delivery and local cultural preferences and norms; 2) translated program materials and protocols available in two languages (to be downloaded and freely available for use on the project website); 3) moderate to strong pre-post differences in very disadvantaged populations during the feasibility pilot study (to be maintained when compared to a control group); successful development of program protocols for 8 different treatment conditions in the factorial experiment; 4) capacity building of 86 program facilitators and 12 coaches with onsite supervision of facilitators and offsite mentorship of coaches provided to treatment conditions allocated to enhanced supervision; 5) successful maintenance of integrity of factorial design during implementation with minimal to no contamination across treatment conditions; and 6) strong engagement with stakeholders on local, national, and international level; 7) successful completion of Phase 2 follow-up assessments despite the challenges due to COVID-19 pandemic; 8) selection of the optimized intervention based on the prespecified optimization criterion during the Consortium meeting. The decision-making process was made by the entire Consortium who was blind for the component levels; 9) Pre-post changes of the optimized intervention were promising; 10) We developed alternative plans for Phase 3 in case local restrictions due to COVID-19 might interfere with the implementation. At this time, it is yet not possible to give any more statements about the results or potential impacts of the study phase (as Phase 3 of this project has not been completed yet).
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