Strategies, processes, outcomes, and costs of implementing experience sampling-based monitoring in routine mental health care in four European countries: study protocol for the IMMERSE effectiveness-implementation study.

BACKGROUND: Recent years have seen a growing interest in the use of digital tools for delivering person-centred mental health care. Experience Sampling Methodology (ESM), a structured diary technique for capturing moment-to-moment variation in experience and behaviour in service users' daily life, reflects a particularly promising avenue for implementing a person-centred approach. While there is evidence on the effectiveness of ESM-based monitoring, uptake in routine mental health care remains limited. The overarching aim of this hybrid effectiveness-implementation study is to investigate, in detail, reach, effectiveness, adoption, implementation, and maintenance as well as contextual factors, processes, and costs of implementing ESM-based monitoring, reporting, and feedback into routine mental health care in four European countries (i.e., Belgium, Germany, Scotland, Slovakia). METHODS: In this hybrid effectiveness-implementation study, a parallel-group, assessor-blind, multi-centre cluster randomized controlled trial (cRCT) will be conducted, combined with a process and economic evaluation. In the cRCT, 24 clinical units (as the cluster and unit of randomization) at eight sites in four European countries will be randomly allocated using an unbalanced 2:1 ratio to one of two conditions: (a) the experimental condition, in which participants receive a Digital Mobile Mental Health intervention (DMMH) and other implementation strategies in addition to treatment as usual (TAU) or (b) the control condition, in which service users are provided with TAU. Outcome data in service users and clinicians will be collected at four time points: at baseline (t0), 2-month post-baseline (t1), 6-month post-baseline (t2), and 12-month post-baseline (t3). The primary outcome will be patient-reported service engagement assessed with the service attachment questionnaire at 2-month post-baseline. The process and economic evaluation will provide in-depth insights into in-vivo context-mechanism-outcome configurations and economic costs of the DMMH and other implementation strategies in routine care, respectively. DISCUSSION: If this trial provides evidence on reach, effectiveness, adoption, implementation and maintenance of implementing ESM-based monitoring, reporting, and feedback, it will form the basis for establishing its public health impact and has significant potential to bridge the research-to-practice gap and contribute to swifter ecological translation of digital innovations to real-world delivery in routine mental health care. TRIAL REGISTRATION: ISRCTN15109760 (ISRCTN registry, date: 03/08/2022).

Open dataset of theory of mind reasoning in early to middle childhood.

Theory of mind (ToM) reasoning refers to the process by which we reason about the mental states (beliefs, desires, emotions) of others. Here, we describe an open dataset of responses from children who completed a story booklet task for assessing ToM reasoning (n = 321 3-12-year-old children, including 64 (neurotypical) children assessed longitudinally and 68 autistic children). Children completed one of two versions of the story booklet task (Booklet 1 or 2). Both versions include two-alternative forced choice and free response questions that tap ToM concepts ranging in difficulty from reasoning about desires and beliefs to reasoning about moral blameworthiness and mistaken referents. Booklet 2 additionally includes items that assess understanding of sarcasm, lies, and second-order belief-desire reasoning. Compared to other ToM tasks, the booklet task provides relatively dense sampling of ToM reasoning within each child (Booklet 1: 41 items; Booklet 2: 65 items). Experimental sessions were video recorded and data were coded offline; the open dataset consists of children's accuracy (binary) on each item and, for many children (n = 171), transcriptions of free responses. The dataset also includes children's scores on standardized tests of receptive language and non-verbal IQ, as well as other demographic information. As such, this dataset is a valuable resource for investigating the development of ToM reasoning in early and middle childhood.