The effectiveness of video feedback intervention on mother-infant interactional quality for women with perinatal mental health illnesses: protocol for a pilot randomised control trial
{"title":"The effectiveness of video feedback intervention on mother-infant interactional quality for women with perinatal mental health illnesses: protocol for a pilot randomised control trial","authors":"Rachel Buhagiar, Kristina Bettenzana, Jane Barlow","doi":"10.18203/2349-3259.ijct20242002","DOIUrl":null,"url":null,"abstract":"Background: The literature strongly suggests that early parent-child relational interventions for at-risk dyads can support healthy infant development and attachment security. Video Feedback (VF) is a widely used attachment-based intervention, but evidence for its effectiveness with mother-baby dyads where there is maternal psychopathology remains limited.\nMethods: This study constitutes a two-armed pilot randomised controlled trial aimed at evaluating the feasibility, acceptability, and preliminary benefits of Video Interaction Guidance (VIG), a type of VF, on mother-child dyadic interactional quality for postpartum women and their infants in Malta. Participants must be mothers with a baby aged 0-12 months who meet criteria for one or more mental health disorders on diagnostic interview. Exclusions are severe maternal mental illness, active drug dependence, being in receipt of in-patient care or therapy, or inability to speak English or Maltese. Consenting, eligible mothers are randomly allocated (minimised by infant age, relationship and employment status, and number of children at home), to either 3 cycles of one-to-one VIG intervention and treatment-as-usual (TAU), or to TAU only. Outcome assessors are blind to study arm allocation. The primary outcomes are parental sensitivity and dyadic synchrony coded using the CARE-index. Secondary outcomes are maternal depression and anxiety, bonding experience, capacity for reflective functioning, and well-being.\nConclusions: This is the first study on the preliminary effectiveness of VIG within perinatal services in Malta. Findings should guide future larger scale, definitive RCTs and subsequently inform health policy and management decisions in perinatal and infant mental health care. \nTrial registration: Registered 16th March 2023 in ISRCTN registry (Trial ID: ISRCTN26320951).","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"4 3","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Trials","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18203/2349-3259.ijct20242002","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Background: The literature strongly suggests that early parent-child relational interventions for at-risk dyads can support healthy infant development and attachment security. Video Feedback (VF) is a widely used attachment-based intervention, but evidence for its effectiveness with mother-baby dyads where there is maternal psychopathology remains limited.
Methods: This study constitutes a two-armed pilot randomised controlled trial aimed at evaluating the feasibility, acceptability, and preliminary benefits of Video Interaction Guidance (VIG), a type of VF, on mother-child dyadic interactional quality for postpartum women and their infants in Malta. Participants must be mothers with a baby aged 0-12 months who meet criteria for one or more mental health disorders on diagnostic interview. Exclusions are severe maternal mental illness, active drug dependence, being in receipt of in-patient care or therapy, or inability to speak English or Maltese. Consenting, eligible mothers are randomly allocated (minimised by infant age, relationship and employment status, and number of children at home), to either 3 cycles of one-to-one VIG intervention and treatment-as-usual (TAU), or to TAU only. Outcome assessors are blind to study arm allocation. The primary outcomes are parental sensitivity and dyadic synchrony coded using the CARE-index. Secondary outcomes are maternal depression and anxiety, bonding experience, capacity for reflective functioning, and well-being.
Conclusions: This is the first study on the preliminary effectiveness of VIG within perinatal services in Malta. Findings should guide future larger scale, definitive RCTs and subsequently inform health policy and management decisions in perinatal and infant mental health care.
Trial registration: Registered 16th March 2023 in ISRCTN registry (Trial ID: ISRCTN26320951).