Doing research in non-specialist mental health services for children and young people: Lessons learnt from a process evaluation of the ICALM (Interpersonal Counselling for Adolescent Low Mood) feasibility Randomised Controlled Trial

Abstract

Abstract Background The rising prevalence of adolescent mild depression in the UK and the paucity of evidence-based interventions in non-specialist sectors where most cases present, creates an urgent need for suitable early psychological interventions. Randomised controlled trials (RCTs) are considered the gold standard method for obtaining unbiased estimates of interventions effectiveness. However, the complexity of mental health settings poses great challenges for evaluating interventions using RCTs. Here we report learnings from an embedded process evaluation of the ICALM (Interpersonal Counselling for Adolescent Low Mood) study which sought to feasibility test the delivery of an RCT of Interpersonal Counselling for Adolescents (IPC-A) in non-specialist sectors. Methods A mixed methods process evaluation using ethnographic methodology which provides an organising structure for investigating context, structured across macro (e.g., wider policy discourse), meso (e.g., service characteristics) and micro (e.g., on-site trial processes) contextual levels. Methods included questionnaires, semi-structured interviews, focus groups, observations, and documentary analysis. Analysis focused on how mapped contextual features shaped trial implementation. Results At a macro-level, delivery of the ICALM study was impacted by the COVID-19 pandemic, structural challenges at referral points and policy implementation challenges. An interaction between enormous demand, a lack of capacity, unclear service specifications and a lack of service coordination at a meso-service level led to low research prioritisation at a micro level thus severely limiting the feasibility of implementing the IPC-A intervention. Conclusions Effective implementation of evaluations in non-specialist sectors must consider the integral role of context. Recommendations for researchers include early stakeholder involvement in considerations of appropriate trial designs, effective recruitment strategies and site engagement. The development of a framework for identifying and delivering evidence-based interventions in this setting may facilitate the building of such a research culture and increase success of recruitment to and implementation of RCTs in this setting. Trial registration ISRCTN registry, ISRCTN82180413, Registered 31 December 2019