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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - RISE (Prevention of child mental health problems in Southeastern Europe - Adapt, Optimize, Test, and Extend Parenting for Lifelong Health)

Teaser

Summary

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 Healthâ€™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).

Work performed

During the first 18 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. According to the Grant Agreement, 12 deliverables were submitted and 4 milestones successfully achieved. Adherence to ethical guidelines and EU regulations was closely monitored and ensured. An ethical application for the overall study was 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 with 140 families 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). Primary outcomes are child aggressive behavior, dysfunctional parenting, and positive parenting. Pre assessments for Phase 2 were completed. A Data management plan was developed and is followed ever since. We further conducted a literature review and analyzed the cost information collected from the feasibility study. Based on that, the framework of cost analysis for the optimization study was designed. A cost diary for the optimization study was developed and implemented. The Intervention was successfully implemented across sites.

Results of the feasibility study were presented at internal and external scientific meetings. Manuscripts on findings from the feasibility study are currently in preparation. The study protocol for Phase 1 was published (Frantz et al., 2019; doi: 10.1136/bmjopen-2018-026684) and the study protocol for Phase 2 was submitted. Several conference presentations of preliminary study results were given and abstracts for future 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. The preliminary results of RISE will be circulated to major international organizations and governmental agencies in Eastern Europe as well as world-wide.

Final results

At this time, it is yet not possible to give any statements about the potential impacts of the project. No concrete results are available yet, but may be provided after the end of Phase 2 (February 2020). Our expected impacts include a) advance prevention strategies and implementation of PLH (2-9), alleviating global burden of mental disorders b) develop an affordable intervention approach for prevention of child behavioral disorders and expand access to care c) inform health service providers, policy and decision makers on effective scaling up of the PLH (2-9) at local, national and regional levels, including affordability aspects for users and health providers d) reduce health inequalities and inequities in the prevention of child behavioral disorders e) maximize the use of existing relevant programs and platforms, f) contribute to the United Nations\' Sustainable Development Goals 3 and the WHO Mental Health Action Plan 2013-2020, g) establish the contextual effectiveness of PLH (2-9), and f) address barriers and obstacles to the expected impacts being achieved.