title: A feasibility randomised controlled trial of the New Orleans intervention for infant mental health: a study protocol.
abstract: Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home) is internationally recognised. However, a recent Glasgow audit showed that many maltreated children "revolve" between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child's neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510).
authors.affiliation: Academic Unit of Mental Health & Wellbeing, University of Glasgow, Caledonia House, Royal Hospital for Sick Children, Glasgow G3 8SJ, UK.
authors.forename: Rachel
authors.initials: R
authors.lastname: Pritchett
authors.forename: Bridie
authors.initials: B
authors.lastname: Fitzpatrick
authors.forename: Nicholas
authors.initials: N
authors.lastname: Watson
authors.forename: Richard
authors.initials: R
authors.lastname: Cotmore
authors.forename: Philip
authors.initials: P
authors.lastname: Wilson
authors.forename: Graham
authors.initials: G
authors.lastname: Bryce
authors.forename: Julia
authors.initials: J
authors.lastname: Donaldson
authors.forename: Kathleen
authors.initials: K
authors.lastname: Boyd
authors.forename: Charles
authors.initials: C
authors.lastname: Zeanah
authors.forename: John
authors.initials: J
authors.lastname: Norrie
authors.forename: Julie
authors.initials: J
authors.lastname: Taylor
authors.forename: Julie
authors.initials: J
authors.lastname: Larrieu
authors.forename: Martina
authors.initials: M
authors.lastname: Messow
authors.forename: Matt
authors.initials: M
authors.lastname: Forde
authors.forename: Fiona
authors.initials: F
authors.lastname: Turner
authors.forename: Susan
authors.initials: S
authors.lastname: Irving
authors.forename: Helen
authors.initials: H
authors.lastname: Minnis
mesh_terms: D000328:Adult; D002649:Child Abuse / Q000523:psychology*; D002675:Child, Preschool; D003657:Decision Making; D005240:Feasibility Studies; D005581:Foster Home Care / Q000331:legislation & jurisprudence / Q000523:psychology; D006801:Humans; D007223:Infant; D008603:Mental Health; D016032:Randomized Controlled Trials as Topic; D012606:Scotland
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