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Background Clinicians and researchers should consider the expected benefits and potential harms of an intervention. Parenting programmes are a widely used evidence-based intervention for child behaviour problems. However, few data are available on potential negative effects. The aims of this paper were to increase systematic knowledge of adverse event (AE) assessment in parenting programmes and to provide an AE assessment tool. Methods As part of the RISE project (prevention of child mental health problems in South-eastern Europe—adapt, optimise, test and extend parenting for lifelong health), we developed and tested an AE assessment procedure in three sequential studies for parents of children with child behaviour problems aged 2 to 9 years in North Macedonia, Republic of Moldova, and Romania. This paper reports on the development of the assessment tool in phase 1 ( N  = 140), phase 2 ( N  = 835), and the final experiences with using the optimised procedures in phase 3 (multisite randomised controlled trial, N  = 823) in which AEs were assessed before, three times during intervention delivery, and at 1 year follow-up. At each time point, the participants completed a 12-item AE checklist. If moderate-to-severe problems of parent or child were reported, a structured follow-up interview was conducted. Results The response rate on the AE assessment tool increased from 6% (phase 1) to 100% (phase 3) indicating improvement in collecting these data based on the experiences of each phase. Results of the RCT (phase 3) showed generally low (S)AE frequencies with the finally optimised procedure: During the intervention, no serious adverse events (SAE) were registered; at least one AE was reported by 10% (after the first session), 7% (after the third session), and 4% (after the last fifth session) of participants. None of the identified (S)AEs was causally related to the study or intervention. Cost–benefit considerations are needed to determine the best way to ensure participant safety in parenting programmes. Conclusion The applied active AE assessment procedure provides a comprehensive AE assessment tool that can be used by others—with adaptations for the specific context, if needed. Based on our experiences, we outline recommendations for future studies. Trial registration ClinicalTrials.gov, registration number phase 1: NCT03552250; phase 2: NCT03865485, phase 3: NCT04721730 . Registered on 13 January 2021.

Background: Childhood adversities, such as poor parental practices, exposure to violence, and risk behaviours strongly impact children's future mental and behavioural problems. Adversities affect families living in disadvantaged environments and low- and middle-income countries (LMICs) to a greater extent than in high-income countries. Parenting programmes are an effective way to alleviate them, although their outreach and scalability is still limited in LMICs. Methods/design: A multi-site randomised controlled trial will be conducted in North Macedonia, Republic of Moldova and Romania to test the efficacy and cost-effectiveness of an optimised version of the promising Parenting for Lifelong Health Programme for Young Children (PLH-YC, 5 sessions), against a standard lecture on parenting issues (control group, 1 session). At least 864 participants who report having children between 2 and 9 years old who display elevated levels of behavioural difficulties will be randomised on a 1:1 basis to the intervention and control groups. The primary outcome will consist of parent report of child oppositional aggressive behaviour. Post-test (four months) and follow-up (12 months) assessments will provide information on short- and longer-term effects of PLH-YC compared to the parenting lecture in the control group. Discussion: This randomised trial will test the efficacy of PLH-YC in alleviating child behavioural problems and assess the cost-effectiveness, transportability across three different cultural contexts, and potential for scalability of the programme. (ZPID).

Abstract High variety in treatment responses is expectable in heterogenous patient groups, such as in individuals with psychosis receiving cognitive behavioral therapy (CBTp). However, knowledge about the diverse trajectories to improvement is limited. This study therefore aimed to detect subgroups of individuals with psychosis with different patterns of change and to identify the covariates associated with these different trajectories. We analyzed data from a sample of individuals with a psychotic disorder (N = 108) who had received CBTp in two German outpatient clinics. Session-by-session measures included general psychopathology to assess symptomatic response and a short version of a patient-reported outcome measure of psychological recovery assessing coping with distressing symptoms, emotions and situations. Growth mixture models were used to identify subgroups of individuals that differed in their trajectories of treatment responses within the first 25 sessions of treatment. For general psychopathology, three distinct trajectories (Symptomatic Response, 50.6%; Symptomatic Non-response, 39.6%; Symptomatic Rebound, 9.9%) and for psychological recovery, two distinct trajectories (Recovery Response, 67.6%; Recovery Non-response, 32.4%) were identified. Post hoc analyses revealed that 90% of those with a symptomatic response also belonged to the recovery response trajectory group. Higher psychotic symptom scores, lower functioning and longer duration of disorder were associated with the symptomatic rebound trajectory. The results underline the encouraging potential of identifying response patterns. The knowledge gained by this type of research can provide a basis for empirically-derived decision rules for clinicians working with this heterogeneous patient group.

Parental engagement in parenting programs is essential for good outcomes but can be challenging for many families. In low- and middle-income countries, where resources are limited and there are fewer support services, there is little research examining the factors that influence engagement. This mixed-methods study explored factors associated with parent engagement, as well as barriers and supports, in a pilot evaluation of a parenting program with 140 parents in North Macedonia, Republic of Moldova, and Romania. The relationship between various quantitative types of engagement (e.g., premature drop-out, participation) and a range of demographic, personal, and implementation factors were examined. Qualitative parent interviews explored barriers and supports to program engagement. Implementation variables (e.g., phone calls with parents, program fidelity and text messages sent to parents) were consistently positively associated with different types of engagement after controlling for other factors. Parents of boys, being a victim of intimate partner violence, more children in the household and better parental well-being were positively associated with premature drop-out whilst having a child enrolled in school was positively associated with participation. Barriers included logistical factors such as timing and lack of childcare facilities. Factors that increased engagement included facilitator skills/support, weekly text messages and phone calls and engagement strategies such as transport and childcare. The results emphasise the importance of implementation factors in increasing parent engagement in parenting programs and will help to inform the next phase of the project as well as other family-support initiatives in the three countries. The trial is registered on ClinicalTrials.gov (ID: NCT03552250).HighlightsA mixed-methods approach was used to examine parent engagement in a parenting program in Southeastern Europe.The most consistent associated factors across the types of engagement were implementation factors.Results will inform later phases of the project and support implementation of parenting programs in Southeastern Europe.

The primary aim of family-based prevention programs is to promote children’s health. Unfortunately, it is difficult to reach families with such evidence-based prevention programs (EBP). Therefore, implementing EBP on a population level could be a promising approach to reach more families, including those faced with socioeconomic challenges who are usually less likely to participate in randomized controlled trials (RCT). Is a population rollout appropriate to reach more and different families than those participating in RCT, especially those representative of the target population? We implemented three EBP in a city in an uncontrolled trial. The effects of this population rollout were tracked on the level of the participating families and on the level of all families living in the city. More than 3480 families (30 % of the population) with children up to 12 years of age participated based on practitioner report. Analyses indicate that a greater percentage of low socioeconomic-status families attended a program compared with a randomly surveyed sample from the city’s general population. The sizes of the within-subject effect for parental strategies, child behavior problems, and children’s quality of life for a subsample of n  = 411 families were similar to those of other uncontrolled EBP studies. The study contributes to highly needed type 2 translation research. The population-based dissemination of EBP could be a promising approach to reach families at risk. However, there are considerable barriers to the implementation process, which currently limit the effectiveness of this rollout in a community.

IntroductionFamilies in low-income and middle-income countries (LMICs) face multiple challenges (eg, poverty and adverse childhood experiences) that increase the risk for child mental health problems, while the context may provide them with few resources. Existing prevention-oriented parenting programmes have been shown to be effective in reducing child behaviour problems and associated risk factors. This project has the overall goal of adapting, implementing and testing a parenting intervention in three Southeastern European LMIC and uses the Multiphase Optimisation Strategy and dimensions of the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. It is implemented over three phases: (1) preparation, (2) optimisation and (3) evaluation. The preparation phase, the subject of this paper, involves the adaptation and feasibility piloting of the parenting programme.Methods and analysisThis protocol describes the assessment of an evidence-informed indicated prevention programme for families with children aged 2–9 years (Parenting for Lifelong Health for Young Children) for implementation in FYR of Macedonia, Republic of Moldova and Romania. In this phase, officials, experts, parents and practitioners are interviewed to explore their views of suitability and needs for further adaptation. In addition, a small pre–post pilot study will test the feasibility of the programme and its implementation as well as the evaluation measures in the three countries with 40 families per country site (n=120). Quantitative data analysis will comprise a psychometric analysis of measures, testing pre–post differences using ANCOVA, χ2 tests and regression analysis. For qualitative data analysis, a thematic approach within an experiential framework will be applied.Ethics and disseminationThe ethics review board of the Alpen-Adria University Klagenfurt and ethical review boards in the three LMIC sites have approved the study.Trial registration number NCT03552250.