Preventing child mental health problems through parenting interventions in Southeastern Europe (RISE): Protocol for a multi-country cluster randomized factorial study.

BACKGROUND: Child mental health problems continue to be a major global concern, especially in low- and middle-income countries (LMICs). Parenting interventions have been shown to be effective for reducing child behavior problems in high-income countries, with emerging evidence supporting similar effects in LMICs. However, there remain substantial barriers to scaling up evidence-based interventions due to limited human and financial resources in such countries. METHODS: This protocol is for a multi-center cluster randomized factorial trial of an evidence-based parenting intervention, Parenting for Lifelong Health for Young Children, for families with children ages 2-9 years with subclinical levels of behavior problems in three Southeastern European countries, Republic of Moldova, North Macedonia, and Romania (8 conditions, 48 clusters, 864 families, 108 per condition). The trial will test three intervention components: 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. Analyses will examine the main effect and cost-effectiveness of each component, as well as potential interaction effects between components, in order to identify the most optimal combination of program components. DISCUSSION: This study is the first factorial experiment of a parenting program in LMICs. Findings will inform the subsequent testing of the optimized program in a multisite randomized controlled trial in 2021. TRIAL REGISTRATION: NCT03865485 registered in ClinicalTrials.gov on March 5, 2019.

Equity effects of parenting interventions for child conduct problems: a pan-European individual participant data meta-analysis.

BACKGROUND: Childhood conduct problems are a costly public health problem and are five times more common in socially disadvantaged groups than they are in advantaged groups. Untreated, conduct problems have a poor prognosis, with increasing gaps between socioeconomic groups, and high rates of subsequent criminality. Incredible Years is a high quality parenting programme for reducing conduct problems and is widely disseminated in Europe. Many trials have shown Incredible Years to be effective but the potential effects of parenting interventions on social inequality are unknown. Some behavioural interventions (eg, smoking cessation programmes), although beneficial overall, can widen inequality gaps. Because single trials and aggregate-level meta-analyses are ill equipped for examining differential intervention (moderator) effects, we pooled individual-level trial data to assess the effects of Incredible Years on social equity. METHODS: We did a systematic review and individual participant data meta-analysis by searching CINAHL, Embase, Global Health, Medline, and PsycINFO, for studies published from inception to March 15, 2019. We also searched the Incredible Years website library and consulted with experts, including the European Incredible Years mentors' network. We included data from all completed randomised trials of the Incredible Years parenting intervention in Europe that included children aged 1-12 years, including unpublished trials, without restriction on publication year or outcome measures. We included prevention (selective or universal) and treatment or indicated prevention trials (for children diagnosed or above the clinical cutoff for conduct problems). We excluded trials or conditions within trials that were not randomised, included additional non-parenting material (eg, child-focused interventions), or were abbreviated, non-standard versions of the usual Incredible Years intervention of 12-14 weekly sessions. We requested individual participant data from the study authors. The primary outcome was child conduct problems, assessed using the Eyberg Child Behavior Inventory Intensity (ECBI-I) scale. Moderators were analysed using multilevel modelling with multiple imputation. FINDINGS: Of 15 European trials of Incredible Years parenting programmes (n=1696 children), individual participant data were unavailable for one trial and one trial did not assess the primary outcome. Children were aged 2-10 years (median 5·1), 492 (30%) of 1651 children were from an ethnic minority and 931 (58%) of 1614 were from low-income families. Families who received the Incredible Years intervention reported an overall reduction in child conduct problems (13·5 points on the ECBI-I scale, 95% CI 10·9-16·1). There were no differential effects by family disadvantage (indicated by poverty, lone parenthood, teenage parenthood, household joblessness, or low education), or ethnic minority status. INTERPRETATION: We found no evidence for differential effects by social disadvantage, suggesting that Incredible Years is unlikely to widen socioeconomic inequalities in conduct problems. Furthermore, the programme might be an important tool for reducing social disparities and improving poor long-term outcomes in disadvantaged families because follow-up studies indicate that benefits persist. Clinicians and commissioners can be reassured that the programme is similarly effective for families from different backgrounds. FUNDING: UK National Institute for Health Research.

Parenting for Autism, Language, And Communication Evaluation Study (PALACES): protocol for a pilot randomised controlled trial.

INTRODUCTION: Children with autistic spectrum disorder (ASD) often have associated behavioural difficulties that can present a challenge for parents and parenting. There are several effective social learning theory-based parenting programmes for dealing with behavioural difficulties, including the Incredible Years (IY) parent programmes. However, these programmes typically do not specifically target parents of children with ASD. Recently, a new addition to the IY suite of programmes known as the IY Autistic Spectrum and Language Delays (IY-ASLD) parent programme was developed. The main aims of the present study are to examine the feasibility of delivering this programme within child health services and to provide initial evidence for effectiveness and economic costs. METHODS AND ANALYSIS: The Parenting for Autism, Language, And Communication Evaluation Study (PALACES) trial is a pragmatic, multicentre, pilot randomised controlled trial comparing the IY-ASLD programme with a wait-list control condition. 72 parents of children with ASD (aged 3-8 years) will be randomly allocated to either the intervention or control condition. Data will be collected prior to randomisation and 6 months postrandomisation for all families. Families in the intervention condition only will also be followed up at 12 and 18 months postrandomisation. This study will provide initial evidence of effectiveness for the newly developed IY-ASLD parenting programme. It will also add to the limited economic evidence for an intervention targeting parents of children with ASD and provide longer term data, an important component for evaluations of parenting programmes. ETHICS AND DISSEMINATION: Approval for the study was granted by the Research Ethics Committee at the School of Psychology, Bangor University (reference number: 2016-15768) and the North Wales Research Ethics Committee, UK (reference number: 16/WA/0224). The findings will be disseminated through research conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN57070414; Pre-results.