Designs and analysis for the evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health

Abstract

This is a proposal for the development, evaluation and dissemination of statistical and econometric methods for the design of explanatory trials of psychological treatments and the explanatory analysis of the clinical and economic endpoints arising from these trials. We are concerned with making valid causal inferences about the mechanisms of treatment-induced change in clinical and economic outcomes.

The present project is focussed on the use of social and psychological markers to assess treatment-effect mediation. The proposed programme of work has three integrated components: (1) the extension of instrumental variable methods to latent growth curve models and growth mixture models for repeated measures data, (2) the development of designs and meta-analytic/meta-regression methods for parallel trials, and (3) the evaluation the sensitivity/robustness of findings to the assumptions necessary for model identifiability. A core feature of the programme will be the development of trial designs involving alternative randomizations to different interventions targeted on specified mediators.

Duration of the project

1st January 2010 - 31st December 2012

Funding body

Medical Research Council - Methodology Research Programme