Efficacy, optimal targeting and mechanisms of a video feedback parent-infant intervention for mothers and birthing persons with severe or complex non-psychotic perinatal mental illness.

BACKGROUND: The NHS Long-Term plan and NICE mandate provision of parent-infant relationship interventions for mothers and birthing people (MABP) with severe perinatal mental illness, and recommend that definitive trials are needed to establish efficacy for improving mother-infant relationships and reducing future child mental health risk. There are currently none establishing efficacy in this population. We have demonstrated proof of concept for the video feedback intervention for positive parenting adapted for perinatal mental health (VIPP-PMH). AIM: To test the efficacy, optimal targeting and mediators of VIPP-PMH for MABP with moderate to severe non-psychotic perinatal mental illness who are experiencing mother-infant relationship problems. Specifically: 1. Is VIPP-PMH more efficacious than specialist perinatal mental health care as usual alone, for improving mother-infant relationships and maternal and child mental health? 2. Is the benefit of VIPP-PMH over perinatal mental health care alone greatest for MABP experiencing more severe mental illness, higher levels of socioeconomic risk, and/ or lower clinician-observed sensitivity during mother-infant interaction? 3. Do improvements in MABPs’ bond with their child and confidence mediate effects of VIPP-PMH on maternal sensitivity and maternal and child mental health? METHODS: Multi-centre, researcher-masked randomised controlled efficacy trial with an internal pilot, with randomisation stratified by key potential moderators, alongside evaluation of intervention mediators and moderators. We will recruit 258 MABP who have a child aged 3 to 12 months, have a moderate to severe non-psychotic mental illness, and are experiencing mother-infant relationship problems, from specialist community perinatal mental health services in 10 NHS Trusts across the UK. MABP in the intervention arm will receive 6 individual sessions of VIPP-PMH, involving watching videos of themselves interacting with their child and receiving positive and strengths-focussed feedback on their child’s communication and the interaction. MABP in the control arm will receive specialist perinatal mental health care as usual alone. The primary outcome is observer-rated maternal sensitivity measured over a 10-month period, using ratings of mother-infant interaction videos with the Ainsworth Sensitivity Scale. Recruitment of 258 MABP will enable 90% power at alpha = 0.05 to detect a minimum clinically important difference of 0.5 in the primary outcome, allowing for 20% attrition. Secondary outcomes are maternal non-intrusiveness, mental illness symptoms, well-being, bonding and parenting confidence over 10 months; child emotional and behavioural problems over 27 months. ANALYSIS: Intention to treat analysis using a general linear mixed model adjusted for baseline score, allocation group and study centre. Analysis of moderators (baseline mental illness severity, socioeconomic risk, type and severity of parent-infant relationship problems) via interaction terms, and mediators (improvements in MABP bonding problems and parenting confidence) via modelling of indirect effects. TIMELINES: M1-9: Set-up; M10-15: Pilot. M16-43: Full trial. M44- 48: Analysis. M45-65: Extended follow-up. IMPACT: Reduction in child mental health problems via increased provision of evidence-based and efficiently targeted parent-infant interventions for MABP experiencing perinatal mental illness. Targeted dissemination to users, providers and policy makers.