IndraLab

Statements



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"Our first aim is to assess the feasibility of CALM-IT as a mobile-paradigm."

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"CALM-IT adoption and completion."

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"CALM-IT therapists received comprehensive CALM training at the Ferrara coordinating center."

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"The development of CALM-IT would allow clinicians and researchers to screen for and track inhibitory control deficits in the community."

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"Finally, we assessed clinical relevance through associations of CALM-IT performance and parent- and child-reported symptoms of anxiety, irritability, and ADHD."

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"We anticipated deficits in CALM-IT inhibitory control performance would be associated with increased levels of psychopathology."

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"CALM-IT feasibility and engagement."

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"Only five participants (2.5%) aborted CALM-IT prior to completion."

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"Four participants (2%) completed CALM-IT, but their data was not collected due to technical issues."

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"Of the remaining participants, eight participants were excluded from analyses of CALM-IT levels 1–5 and 12 participants were excluded from analyses of levels 6–10, due to technical difficulties impacting the number of targets and stars presented."

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"Demonstrating feasibility and acceptability, 94.79% of participants who were contacted to assess interest in completing CALM-IT agreed to do so."

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"In what sense is the new application CALM-IT less repetitive?"

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"The goal of the current study is to develop a developmentally appropriate, engaging, novel mobile application called CALM-IT that probes a narrow biologically informed process, inhibitory control."

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"The development of CALM-IT has significant implications for the ability to screen for inhibitory control deficits in the community by both clinicians and researchers."

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"Additionally, in the clinical setting, CALM-IT represents a novel clinical screening measure that could be used to determine personalized courses of treatment based on the presence of inhibitory control deficits."

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"The current study introduces a mobile application, “CALM-IT,” an engaging, patient and clinician user-friendly, accessible and disseminatable cognitive measure that probes inhibitory control, a well-validated behavioral construct that has been posited as one critical mechanism underlying childhood psychopathology broadly [ xref , xref , xref ]."

sparser
"Ultimately, CALM-IT could lead to novel clinical screening measures for inhibitory control deficits that could be used to inform a personalized course of treatment."

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"Aim 1 : Assessment of feasibility and consistency of CALM-IT."

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"In developing CALM-IT, we aim to flexibly deploy the rigorous and robust methods traditionally used in laboratory settings to validate a mechanism-driven but easily disseminatable tool that can be used by clinicians to probe inhibitory control in the community."

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"The goal of the present work is to leverage the strong psychometric properties of a canonical inhibitory control task in the creation of CALM-IT."

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"By targeting a precise pathophysiologically-informed mechanism, and using a platform that is highly engaging and easily disseminated in pediatric samples, the mobile application CALM-IT was designed to bridge the gap between precise mechanisms-driven basic science research and community-based assessment of childhood psychopathology."

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"CALM-IT is designed to leverage the strong methodological design of well-established laboratory based inhibitory control tasks while increasing participant engagement through gamification of the tasks."

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"By using a mobile platform, participant interaction with CALM-IT mirrors those with other mobile-based games with the goal of increasing participant engagement via dynamic stimuli and in-game incentives."

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"Finally, a follow-up interview will be conducted to collect a qualitative assessment of CALM-IT engagement from each participant."

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"We will conduct a multiple regression analysis with CALM-IT d’ as a predictor of inhibitory control latent factor scores, with age, sex, order of task completion (e.g., CALM-IT or laboratory testing administered first), and IQ entered as covariates."

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"First, raw bivariate correlations between raw total scores on the five symptom measurements and CALM-IT d’ will be examined."

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"All four latent factor scores from the bifactor model will be entered as concurrent predictors of CALM-IT d’."

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"For all models, any demographic variable that varies as a function of either symptoms and/or CALM-IT d’ will be included as a covariate (i.e., age, sex, and IQ)."

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"Furthermore, an adaptive version of CALM-IT that increases difficulty based on participants’ individual performance could function as an intervention aimed at improving inhibitory control."

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"CALM-IT is poised to provide an accessible tool for clinicians in the community to make clinical and treatment decisions based on neuroscience-based mechanisms."

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"Rationale and validation of a novel mobile application probing motor inhibition: Proof of concept of CALM-IT"

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"The abstract could be more specific and include the importance of this research and the possibility of future application of the CALM-IT in clinical practice."

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"To summarise the existing evidence of this problem may give a better understanding of the importance of this study and the CALM-IT application."

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"CALM-IT is a mobile behavioral task and not specifically a software or software package."

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"Second, we now more explicitly discuss the aspects of CALM-IT that allow it to be both more easily accessible and engaging while still leveraging the methodological designs from well-established paradigms (p."

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"Administration of CALM-IT will occur outside of the laboratory setting."

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"Families will be sent instructions on how to download CALM-IT onto their mobile device."

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"As such, CALM-IT testing sessions will be completed within a community setting (e.g. at home) at whatever time is most convenient for the family."

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"Parents will be instructed that CALM-IT should be played only by the child with no assistance."

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"Families will receive monetary compensation for completion of CALM-IT."

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"We believe that the first critical step is to first establish validity of CALM-IT as a measure of baseline inhibitory control and thus have limited versions of the game to two, one modeled after go-no-go and one modeled after stop signal delay paradigms."

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"While this is out of the scope of the current proposed project, we now include additional discussion of potential future versions of CALM-IT should the proposed study confirm valid measurement of inhibitory control using the current proposed version of CALM-IT (p."

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"“To investigate the feasibility of CALM-IT (Aim 1a), we will recruit 200 youth."

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"For investigation of the stability of CALM-IT (Aim 1b), we will invite 75 youth out of the overall sample of 200 to play CALM-IT twice."

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"Qualitative data from this study indicated that CALM-IT provides the experience of a secure relationship and reflective space in which illness-related issues and the end of life can be addressed."

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"For the feasibility of CALM-IT (Aim 1a), our proposed sample size is sufficient to detect effects of r≥0.20."

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"For the stability of CALM-IT (Aim 1b), our proposed sample size is sufficient to detect effects of r≥0.32."

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"One of central aims of CALM-IT is to create a more engaging measurement of inhibitory control that could limit confounding issues of loss of attention or limited motivation."

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"Thus, we agree with the reviewer that it is critical that we evaluate the degree to which CALM-IT was in fact engaging."

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"“Finally, a follow-up interview will be conducted to collect a qualitative assessment of CALM-IT engagement from each.”"

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"Here, we developed CALM-IT, a novel mobile-application to experimentally assess inhibitory control in vivo"

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"Recently, JZP541 has been undergoing phase 2 trials to evaluate the safety and therapeutic efficacy for managing agitation in patients with AD (CALM-IT, NCT06014424)."

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"The intervention, called Managing Cancer and Living Meaningfully (CALM), was originally developed in Canada and we are now testing its Italian adaptation (CALM-IT)."

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"The study is a single-blinded phase III RCT with assessment at baseline, 3 and 6 months with two conditions: CALM-IT versus a nonspecific supportive intervention (SPI)."

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"CALM-IT includes up to 12 sessions, delivered over 6 months and covers 4 domains: i) Symptom Management and Communication with Health Care Providers; ii) Changes in Self and Relations with Close Others; iii) Sense of Meaning and Purpose; and iv) the Future and Mortality."

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"If shown to be effective, CALM-IT can be implemented nationally to relieve distress and to promote psychological well-being in patients with advanced cancer."

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"By using a game-based interface that can be completed using mobile-devices, CALM-IT was designed to extend traditional laboratory-based cognitive control tasks into an engaging, accessible mobile assessment of inhibitory control."

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"Using the development of “CALM-IT” as a proof of concept, we present a roadmap for the development of novel mobile-based behavioral assessments to further better understanding of mechanisms of psychopathology."

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"Our pilot work with “CALM-IT” has a focus on addressing anxiety, irritability, and ADHD symptoms, as these are common, impairing, and tend to co-occur across a spectrum of childhood psychopathology [ xref – xref ]."

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"In this paper, we used the development of CALM-IT as a proof of concept for this roadmap, providing a concrete example of implementing each of the roadmap’s steps."

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"First, we applied knowledge from two canonical inhibitory control tasks, Go/No-Go [ xref ] and Stop Signal [ xref ] Delay Paradigms, to inform the methodological design of CALM-IT."

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"In a transdiagnostic sample of 200 youth aged 8–20, we (i) apply knowledge from canonical inhibitory control tasks in the methodological design of the mobile application, (ii) establish feasibility and engagement with CALM-IT, (iii) assess test-retest reliability of CALM-IT, (iv) investigate the convergent validity of CALM-IT with behavioral and neural responses to laboratory-based tasks, and (v) probe clinical relevance via associations with clinical symptoms."

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"First, we provide evidence that our novel inhibitory control mobile application, CALM-IT, was accessible, feasible, and engaging."

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"Third, we found CALM-IT performance was associated with established measures of inhibitory control and activation in the bilateral inferior frontal gyrus."

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"Finally, we found evidence linking impaired CALM-IT performance to increased levels of co-occurring anxiety, irritability, and attention deficit hyperactivity disorder (ADHD) symptoms."

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"Specifically, we describe the novel mobile application to measure inhibitory control, “CALM-IT.” We designed CALM-IT to build off the strengths of traditional laboratory-based cognitive control tasks while addressing issues with engagement, accessibility, and cost-effectiveness of these often laborious and time-intensive experimental tasks particularly within developmental samples [ xref ]."

sparser
"We hypothesized that CALM-IT performance would be associated with both behavioral and neural lab-based metrics of inhibitory control."

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"Second, we assessed feasibility and engagement with CALM-IT and hypothesized that we would observe high rates of task completion and performance accuracy."

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"Third, we assessed test-retest reliability of CALM-IT across two sessions spaced approximately 1-week apart and hypothesized that inhibitory control performance as measured by CALM-IT would be reliable over time."

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"Fourth, we assessed convergent validity of CALM-IT against a latent variable of inhibitory control behavior estimated from participants’ task performance across four laboratory tasks and neural response to cognitive conflict using the Eriksen Flanker Task."

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"Bivariate correlations between CALM-IT d-prime and inhibitory control latent factor scores indicated that, as predicted, higher CALM-IT d-prime scores were associated with better inhibitory control performance on canonical in-laboratory tasks for both levels 1–5, r  = ."

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"We repeated analyses controlling for age following examination of correlations with CALM-IT d-prime ( p s < ."

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"After controlling for age, no associations between CALM-IT d-prime and inhibitory control latent factor scores survived (Levels 1–5 b  = 0.14 p  = 0.128, Levels 6–10 b  = 0.14, p  = ."

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"05), such that increased activation in the bilateral IFG in response to conflict was associated with better CALM-IT performance."

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"Consistent with prior work [ xref ], examination of associations of CALM-IT d-prime with factor scores derived from our bifactor model revealed associations with higher general psychopathology factor scores, but not any of the symptom-specific factors ( xref )."

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"Associations between general psychopathology factor scores remained significantly associated with both CALM-IT levels 1–5 d-prime, b  = -0.16 p  = 0.047, and levels 6–10 d-prime, b  = -0.22 p  = 0.006, even after controlling for age."

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"When examining associations with self- and parent-report symptom assessments total scores, associations emerged between CALM-IT d-prime and higher levels of irritability (parent-report with levels 1–5 d-prime: r (165)=-0.21 p =  ."

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"Last, exploratory analyses examining associations with subtypes of ADHD and depression found associations with higher hyperactive impulsive ADHD scores CALM-IT performance across levels 1–5 ( r (163)=-0.27 p <  ."

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"001) and associations with higher inattentive ADHD scores for CALM-IT performance on levels 6–10 ( r (161)=-0.22 p  = ."

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"After controlling for age, all associations between self- and parent-report symptoms with CALM-IT performance were no longer significant."

sparser
"In the current study we leveraged mobile technology to develop a novel, gamified, and easily disseminable tool, “CALM-IT”, to experimentally assess inhibitory control behaviors in vivo."

sparser
"Second, CALM-IT performance was moderately reliable over time."

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"Finally, CALM-IT performance was related to increased levels of co-occurring anxiety, irritability, and ADHD symptoms."

sparser
"We applied knowledge from two canonical inhibitory control laboratory-based tasks, Go/No-Go and Stop Signal Delay task, to inform CALM-IT’s methodological design."

sparser
"Next, we demonstrated feasibility and engagement with CALM-IT."

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"Next, we demonstrated moderate test-retest reliability of inhibitory control behavior as measured by CALM-IT, across two time points, approximately 1 week apart."

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"These findings provide confidence in the stability of inhibitory control behavior as measured by CALM-IT."

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"Importantly, moderate levels of test-retest reliability suggest that CALM-IT may be leveraged to gain repeated measures of inhibitory control behavior across time to capture intra-individual variation."

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"As such, CALM-IT could be integrated into ecological momentary assessment protocols to provide repeated experimental measures of inhibitory control across time and thus allowing for the investigation of temporal relationships between mood, clinical symptoms, and other clinically relevant behaviors (i.e., sleep) through within-subject repeated measures of these behaviors (e.g., EMA paired with CALM-IT)."

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"To assess convergent validity of behaviors measured by CALM-IT, we examined associations with a latent factor of inhibitory control estimated across four canonical in-laboratory tasks."

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"Average performance metrics indicated strong engagement with CALM-IT, such that, on average, participants successfully hit 91.28% of targets (SD = 7.59) for Levels 1–5 and 78.03% of targets (SD = 8.73) for Levels 6–10, and successfully avoided hitting 79.80% of stars (SD = 17.71) for Levels 1–5 and 87.54% of stars (SD = 14.56) for Levels 6–10."

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"CALM-IT test-retest reliability."

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"To assess temporal stability, we assessed test-retest reliability in the subset of participants who completed CALM-IT twice, approximately one week apart."

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"Results indicated moderate reliability for levels 1–5 percentage of targets hit, ICC(3,1)=0.60 CI [0.47–0.70], percentage of stars hit, ICC(3,1)=0.50 CI [0.36–0.63], and CALM-IT d-prime, ICC(3,1)=0.50 CI [0.35–0.62], and for levels 6–10 percentage of targets hit, ICC(3,1)=0.61 CI [0.49–0.71], percentage of stars hit, ICC(3,1)=0.62 CI [0.49–0.72], and CALM-IT d-prime, ICC(3,1)=0.48 CI [0.33–0.61]."

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"CALM-IT convergent validity."

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"While associations emerged between CALM-IT inhibitory control behavior and inhibitory control latent factor scores, this association did not remain after controlling for age."

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"Given that our current sample encompasses a developmental period characterized by rapid development of inhibitory control, [ xref ] it is unsurprising that a strong association between age and inhibitory control emerged as measured both by in-laboratory tasks and CALM-IT."

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"Region of interest analyses identified associations between activation in the bilateral IFG and CALM-IT performance for the last five levels thus linking biological correlates of inhibitory control to CALM-IT performance."

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"Of note, the observed association was with levels 6–10, but not levels 1–5 of CALM-IT."

sparser
"Finally, we identified clinical relevance through associations with measures of anxiety, irritability, and ADHD symptoms and found that impaired inhibitory control, as measured by CALM-IT, was associated with higher levels of the general latent factor for our bifactor model of clinical symptoms (i.e., shared or comorbid psychopathology), even after controlling for age."

sparser
"As such, easily accessible and disseminatable tools for experimentally assessing inhibitory control in vivo, such as CALM-IT, have significant clinical implications for childhood psychopathology broadly."

sparser
"The current application of our proposed framework to the development of CALM-IT has several limitations."

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"First, while overall engagement with CALM-IT was strong, we faced technical issues that resulted in loss of data."

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"Next, there was variability across participants in the time elapsed between CALM-IT gameplay and measures of in-laboratory inhibitory control behavior and neural response to cognitive conflict."

sparser
"This work represents an important first step, and future work is needed examine the potential for targeted mobile applications such as CALM-IT to predict symptom time courses and treatment outcomes."

sparser
"After controlling for age, all associations between self- and parent-report symptoms with CALM-IT performance were no longer significant." but the discussion and abstract treats this findings as remaining significant after accounting for age."

sparser
"The revision is now clarifies the intent of the diagnostic tool CALM-IT."

sparser
"Nevertheless, I also believe that authors should rope in a computer scientist cum app developer to further validate and upload the CALM-IT tool on Google Playstore/Apple store for furthering their assessment platform's accessibility from a utilitarian perspective."

sparser
"Considering the conclusion, I wish that authors should go a step ahead to develop, test, and validate the CALM-IT platform and make it more inclusive for all sort of samples in near future."

sparser
"Adding more snapshots of the CALM-IT would make more sense."