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Ramchandani P, O'Farrelly C, Babelis D, Bakermans-Kranenburg M, Byford S, Grimas E, Iles J, van IJzendoorn M, McGinley J, Phillips C, Stein A, Warwick J, Watt H, Scott Set al., 2017, Preventing enduring behavioural problems in young children through early psychological intervention (Healthy Start, Happy Start): study protocol for a randomized controlled trial, Trials, Vol: 18, ISSN: 1745-6215

Background: Behavioural problems are common in early childhood, and can result in enduring costs to the individualand society, including an increased risk of mental and physical illness, criminality, educational failure and drug andalcohol misuse. Most previous research has examined the impact of interventions targeting older children whendifficulties are more established and harder to change, and have rarely included fathers. We are conducting a trial of apsychological intervention delivered to families with very young children, engaging both parents where possible.Methods: This study is a two-arm, parallel group, researcher-blind, randomized controlled trial, to test the clinicaleffectiveness and cost-effectiveness of a parenting intervention, Video Feedback Intervention to Promote PositiveParenting and Sensitive Discipline (VIPP-SD) for parents of young children (12–36 months) at risk of behaviouraldifficulties. VIPP-SD is an evidence-based parenting intervention developed at Leiden University in the Netherlandswhich uses a video-feedback approach to support parents, particularly by enhancing parental sensitivity and sensitivediscipline in caring for children.The trial will involve 300 families, who will be randomly allocated into either an intervention group, who will receivethe video-feedback intervention (n = 150), or a control group, who will receive treatment as usual (n = 150). The trialwill evaluate whether VIPP-SD, compared to treatment as usual, leads to lower levels of behavioural problems in youngchildren who are at high risk of developing these difficulties. Assessments will be conducted at baseline, and 5 and24 months post-randomization. The primary outcome measure is a modified version of the Preschool Parental Accountof Child Symptoms (Pre-PACS), a structured clinical interview of behavioural symptoms. Secondary outcomes includecaregiver-reported behavioural difficulties, parenting behaviours, parental sensitivity, parental mood and anxiety a

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