| Title {1} | The Best Services Trial (BeST?): a cluster randomised controlled trial comparing the clinical and cost-effectiveness of New Orleans Intervention Model with Services as Usual (SAU) for infants and young children entering care |
| Trial registration {2a and 2b}. |
Registered in ClinicalTrials.gov: NCT02653716 Effectiveness and Cost-effectiveness of the New Orleans Intervention Model for Infant Mental Health - Full Text View - ClinicalTrials.gov |
| Protocol version {3} | Version 7.0 12.05.2020 |
| Funding {4} |
NIHR Chief Scientist’s Office NSPCC |
| Author details {5a} |
SPIRIT guidance: Affiliations of protocol contributors. Karen Crawford, Helen Minnis - Mental Health and Wellbeing, Institute of Health and Wellbeing, University of Glasgow Alex McConnachie and Martina Messow - Robertson Centre for Biostatistics, University of Glasgow Emma McIntosh and Kathleen Boyd, Health Economics and Health Technology Assessment, University of Glasgow Marion Henderson - School of Social Work and Social Policy, University of Strathclyde Phil Wilson – Centre for Rural Health, University of Aberdeen Matt Forde - NSPCC Susanne Millar - Glasgow Health and Social Care Partnership Bridie Fitzpatrick, Centre for General Practice and Primary Care, University of Glasgow Lynn McMahon, Stratified Medicine Scotland Innovation Centre, University of Glasgow Dennis Ougrin, Institute of Psychiatry, Psychology and Neurodevelopment, Kings College London |
| Name and contact information for the trial sponsor {5b} |
SPIRIT guidance: Name and contact information for the trial sponsor. Emma McDonough, Sponsor’s Representative, NHS Greater Glasgow and Clyde Research and Innovation Ward 11 Dykebar Hospital Grahamston Road Paisley PA2 7DE Email: Emma.McDonough@ggc.scot.nhs.uk Tel: 0141 314 4011 |
| Role of sponsor {5b} | Sponsor has delegated responsibility for the conduct of the trial. The sponsor’s responsibility is to confirm there are proper arrangements in place to initiate, manage, monitor and finance the study and to ensure proper indemnity is in place. |