Neuropsychological Stimulation Program for Children from Low Socioeconomic Backgrounds: Study Protocol for a Randomized Controlled Trial

Ci a ion: Rod íguez-P ie o, P.; Simpson, I.C.; Gomez-Baya, D.; Ga cía de la Cadena, C.; Ruiz-A anda, D.; Ibáñez-Al onso, J.A. Neu opsychological S imula ion P og am o Child en om Low Socioeconomic Backg ounds: S udy P o ocol o a Randomized Con olled T ial. Heal hca e 2024,12, 596. h ps:// doi.o g/10.3390/heal hca e12050596 Academic Edi o s: Xiang-Yu Hou, Lijun Fan and Chiung-Jung (Jo) Wu Recei ed: 2 Feb ua y 2024 Re ised: 2 Ma ch 2024 Accep ed: 4 Ma ch 2024 Published: 6 Ma ch 2024 Copy igh : © 2024 by he au ho s. Licensee MDPI, Basel, Swi ze land. This a icle is an open access a icle dis ibu ed unde he e ms and condi ions o he C ea i e Commons A ibu ion (CC BY) license (h ps:// c ea i ecommons.o g/licenses/by/ 4.0/). heal hca e S udy P o ocol Neu opsychological S imula ion P og am o Child en om Low Socioeconomic Backg ounds: S udy P o ocol o a Randomized Con olled T ial Pablo Rod íguez-P ie o 1,2 , Ian C aig Simpson 3, Diego Gomez-Baya 4, Claudia Ga cía de la Cadena 5, Desi ée Ruiz-A anda 1and Joaquín A. Ibáñez-Al onso 1,2,* 1Human Neu oscience Lab, Depa men o Psychology, Uni e sidad Loyola Andalucía, A da. de las Uni e sidades s/n, 41704 Dos He manas, Spain; [email p o ec ed] (P.R.-P.); [email p o ec ed] (D.R.-A.) 2ETEA Founda ion, De elopmen Ins i u e o Uni e sidad Loyola Andalucía, Calle Esc i o Cas illa Aguayo n◦4, 14004 Có doba, Spain 3Depa men o Expe imen al Psychology, Campus Uni e si a io de Ca uja, Uni e si y o G anada, 18071 G anada, Spain; isimpson@ug .es 4Depa men o Social, De elopmen al and Educa ional Psychology, Campus de El Ca men, Uni e si y o Huel a, 21071 Huel a, Spain; [email p o ec ed] 5Depa men o Neu opsychology, Uni e sidad del Valle de Gua emala, Calle 11, Zona 15, Pos n◦82, Gua emala Ci y 01901, Gua emala; [email p o ec ed] *Co espondence: [email p o ec ed]; Tel.: +34-955-641-600 (ex . 2483) Abs ac : Backg ound: Gua emala emains one o he poo es coun ies in Cen al Ame ica and su e s om high a es o social inequali y and iolence. In addi ion o he nega i e impac ha wo yea s wi hou a ending school has had on Gua emalan child en due o he consequences o he COVID-19 pandemic, his un a ou able socioeconomic con ex poses a isk o child en’s emo ional and cogni i e de elopmen . This wo k p esen s a p o ocol o implemen ing a cogni i e and emo ional s imula ion p og am aimed a inc easing he academic pe o mance o hese child en and consequen ly imp o ing hei quali y o li e. Me hods: The p o ocol p oposes he implemen a ion o a andomized con olled ial o assess he e icacy o a 24-session-long s imula ion p og am. I a ge s he cogni i e unc ions o a en ion, language, execu i e unc ions, and social cogni ion, using he digi al neu o ehabili a ion pla o m Neu onUP. The pa icipan s (n= 480) will be andomly assigned o an Expe imen al o Con ol g oup. P e- and pos -in e en ion assessmen s will be ca ied ou , oge he wi h a ollow-up in he nex academic yea , in which bo h g oups will change oles. Resul s will be compa ed o he i s and second yea s, looking o di e ences in academic and cogni i e pe o mance be ween g oups. Discussion: Mid- and long- e m ou comes a e s ill unknown, bu e ec i e in e en ions based on his p o ocol a e expec ed o acili a e he ollowing bene i s o pa icipan s: (1) imp o ed cogni i e and emo ional de elopmen ; (2) imp o ed academic pe o mance; (3) imp o ed well-being. We expec o c ea e a alida ed neu opsychological s imula ion p og am ha could be applied in simila socioeconomically disad an aged con ex s a ound he wo ld o help hese child en imp o e hei li e chances. Keywo ds: neu opsychology; childhood de elopmen ; ulne abili y; cogni i e s imula ion; emo ional ; andomized con olled ials 1. In oduc ion The pandemic (COVID-19) ep esen ed an ex eme h ea o he ad ancemen o educa ion in Gua emala because o he signi ican impac i has had a a ious le els. A a local le el, educa ional cen es we e closed o almos wo yea s, and mo e b oadly, he e has been an economic ecession a he na ional and wo ldwide le els. The closu es wi hin he school sys em caused a s agna ion o lea ning, along wi h an inc ease in school d opou s and a educ ion in school a achmen [ 1 ]. The coun y’s economic c isis impac ed he mos Heal hca e 2024,12, 596. h ps://doi.o g/10.3390/heal hca e12050596 h ps://www.mdpi.com/jou nal/heal hca e Heal hca e 2024,12, 596 2 o 13 ulne able indi iduals, di ec ly a ec ing hei quali y o li e and inc easing he inequali ies ha al eady exis wi hin he coun y [ 2 ]. Some o he impac s on s uden s and hei amilies, who ha e been in a o ced dis ance-lea ning model o he pas wo yea s, include wo sening nu i ional si ua ions (due o he s uden s no being ed a schools), de e io a ing men al heal h (pa icula ly inc eased anxie y, s ess, and bu nou symp oms [ 3 – 6 ]), and a wo sening ulne abli y [ 1 ]. I is impo an o men ion ha child labou , abuse, and unwan ed p egnancies a e p oblems ha also mani es when schooling becomes home- based [ 7 , 8 ]. Consequen ly, i is necessa y o implemen conc e e s a egies o coun e ac o lessen he impac o his si ua ion as much as possible, and his is he mo i a ion o de eloping he ollowing in e en ion p o ocol. Gua emala emains one o he poo es coun ies in he Ame ican con inen wi h high a es o social inequali y and iolence, in which s uc u al p oblems such as acial disc imina ion, gende inequali y, ex eme po e y and exclusion, an uns able poli ical si ua ion, and an abe an lack o access o jus ice cons i u e obs acles o he ull enjoymen o human igh s [ 2 ]. Addi ionally, acism and disc imina ion agains indigenous peoples a e deeply oo ed. The indigenous popula ion aces mo e un a ou able condi ions han he non-indigenous popula ion in e ms o access o employmen , heal h, educa ion, as well as a e age income and a es o ex eme po e y [ 2 ]. Gua emala is a di e se, mul ilingual, and mul icul u al coun y wi h 22 language communi ies. Acco ding o da a om he las Census [ 9 ], he es ima ed Gua emalan popula ion in 2020 was 16,858,333 inhabi an s. The coun y’s g oss domes ic p oduc pe capi a is a ound 39,043 que zals, which would co espond o app oxima ely 5 US dolla s. I is he coun y in La in Ame ica wi h he mos ch onic child malnu i ion and he ou h wo ldwide, acco ding o da a om he Wo ld Bank [ 2 ]. O ele ance, in e ms o he dis ibu ion o he coun y’s inhabi an s, hal o he popula ion esides in u al a eas, whe e h ee ou o ou inhabi an s li e in po e y [ 2 ]. The schools whe e he in e en ion will be ca ied ou a e in so-called high- isk a eas loca ed wi hin he depa men o Gua emala. These a e a eas whe e ex eme iolence, assaul s, mu de s, and ex o ion a e si ua ions ha happen daily, and he isk o d opping ou o school is e y high due o easons including lack o money, child labou , o s uden demo i a ion [10]. Li ing condi ions du ing childhood and adolescence a ec he cogni i e and emo ional de elopmen o mino s, esul ing in impo an long- e m e ec s in hei adul li e [11–14]. Exis ing li e a u e on g owing up in disad an aged en i onmen s epo s ha language de- elopmen , a en ion, and execu i e unc ions can all be a ec ed. Addi ionally, expe iencing hese ypes o ad e se con ex s can also ha e a conside able nega i e impac on child en’s social skills and emo ional egula ion [ 15 – 18 ]. The de elopmen o his s udy p o ocol a ises om he need o espond o some o he p oblems disco e ed a e he conclusion o a p e ious p ojec [ 19 ]. I s goal was o imp o e exis ing neu opsychological assessmen ask sco es o child en and adolescen s in Gua emala and s udy how di e en ac o s wi hin hei en i onmen could a ec hei cogni i e de elopmen . The esul s ob ained in his p e ious s udy e ealed ha Gua emalan child en and adolescen s pa icipa ing in he p ojec needed e ec i e suppo on mul iple le els due o hei si ua ions o ulne abili y. In his s udy, ulne abili y was de ined as belonging o an especially disad an aged socioe- conomic con ex , bo h in e ms o po e y and di ec exposu e o ex eme iolence; his was he de ini ion used in he p e ious s udy [ 20 ]. This showed ha he hypo heses ega ding he nega i e impac o g owing up in disad an aged socioeconomic en i onmen s (e.g., low educa ional le el o ca egi e s, li le in ellec ual s imula ion in hei en i onmen , ood insecu i y) on he cogni i e pe o mance o child en and adolescen s we e con i med in his popula ion [ 20 ]. Addi ionally, i was possible o de ec a se ies o men al heal h di icul ies in some o he pa icipan s ha could no be le una ended. This included high le els o anxie y and dep ession, especially among child en om u ban a eas wi h high a es o iolence [ 21 ]. In summa y, e idence indica es ha li ing condi ions du ing childhood and adolescence a ec he cogni i e and emo ional de elopmen o child en, ha ing signi ican e ec s on hei academic pe o mance, which in u n ends o condi ion hei long- e m Heal hca e 2024,12, 596 3 o 13 adul li e [ 12 – 14 ]. Likewise, he s ess associa ed wi h po e y causes a se ious impac on he emo ional and social de elopmen o hese child en, highligh ing he u gen need o wo k in hese a eas [22,23]. Neu opsychological s imula ion p og ams ocused on bo h cogni i e and emo ional unc ions ha e a long adi ion in he clinical ield, being he ea men o i s choice in a ious neu ode elopmen al diso de s [ 24 ]. These p og ams a e designed o ain speci ic cogni i e skills (such as a en ion, memo y, language, e c.), wi h a wide ange o ac i i- ies, games, and o he media, so pa ien s can imp o e cogni i e skills ha a e no ully acqui ed/de eloped (due o neu ode elopmen al diso de s) o ha e declined (due o ac- qui ed b ain damage o degene a i e illnesses). In addi ion, esea ch exis s demons a ing he e icacy o neu opsychological in e en ions ocused on speci ic cogni i e domains in non-clinical child popula ions belonging o socioeconomically ulne able con ex s [ 25 – 27 ]. The esul s sugges ha p o ocols employing di e en agen s and ma e ials in cogni i e in e en ion, wi h ea ly in e en ion and a la ge numbe o sessions, a e he mos e ec i e. I has also been shown ha child en li ing in socioeconomically ulne able con ex s can also bene i om lea ning emo ional egula ion ools o cons uc i ely ace he a ious isk si ua ions hey a e equen ly exposed o in hei daily li es [ 28 ]. Ne e heless, we no ed ha scien i ic e idence on he e icacy o neu opsychological s imula ion p og ams o child en a isk o social exclusion, and hei posi i e e ec s on cogni i e and emo ional skills, as well as hei expec ed impac on academic pe o mance and quali y o li e, is s ill somewha limi ed [27,29,30]. The p e ious s udies and ac o s men ioned abo e ha e been s ong mo i a ion o he de elopmen o he ollowing p o ocol o he neu opsychological s imula ion p og am. The implemen a ion o a neu opsychological in e en ion p og am ha s imula es bo h cog- ni i e de elopmen (especially hose men al unc ions in which a g ea e nega i e impac o he socioeconomic con ex was de ec ed), as well as emo ional skills ha ein o ce he socio- emo ional de elopmen o hese child en (an impo an p o ec i e ac o agains mood swings and o he men al heal h diso de s o which hey a e equen ly exposed) would be g ea ly bene icial o child en li ing in socioeconomically ulne able con ex s [31,32]. 2. Ma e ials and Me hods 2.1. Pa icipan s and S udy Se ing 2.1.1. Pa icipan s’ Cha ac e is ics S uden s om he 5 h g ade o p ima y school, om educa ional cen es loca ed in pa icula ly ulne able a eas om Gua emala Ci y’s subu bs, will be in i ed o pa icipa e in he in e en ion p og am. The eason o choosing his g ade is ha he app oxima e age o he child en in his school s age a e a he minimum ha ensu es hey ha e ac- qui ed ce ain skills necessa y o adequa e pa icipa ion in he in e en ion p og am (e.g., su icien abili y o sus ain hei a en ion, eading comp ehension, e c.), and he e o e, hey may bene i mo e om he p oposed in e en ion. I has been ound ha his is he op imal educa ional le el o s imula ion p og ams o succeed [ 33 , 34 ]. Mos child en will be be ween 10 and 12 yea s old. Howe e , gi en he challenging social backg ound and cou se dis up ion caused by he pandemic, i is likely ha he e will be child en 1–2 yea s olde in his g ade. The ollowing addi ional inclusion c i e ia will be conside ed: - Being a p o icien speake o he Spanish language. - Ha ing acqui ed su icien eading skills o unde s and he ac i i ies included in he in e en ion (pe cen ile sco e > 5 in he In e -Ame ican Reading Se ies L-3-DEs). - Ha ing a su icien le el o non- e bal in elligence o unde s and and in e ac wi h he ac i i ies included in he in e en ion (pe cen ile sco e > 5 in he Non-Ve bal In elligence Tes TONI-2). - No ha ing a diagnosis o se ious senso y o mo o di icul ies, o ha ing insu icien ly co ec ed ones, which would p e en adequa e pe o mance in in e en ion ac i i ies. Heal hca e 2024,12, 596 4 o 13 2.1.2. Rec ui men S a egy Fe y Aleg ía is an in e na ional Jesui NGO dedica ed o c ea ing schools and o e ing educa ion in socioeconomically disad an aged a eas h oughou many Spanish-speaking coun ies. In Gua emala, hey cu en ly ha e a coun y-wide ne wo k o educa ional cen es, consis ing o 46 schools in o al. Fi e cen es loca ed in he u ban a ea ha e been chosen as a sample o ep esen he o al popula ion o hei s uden s due o he la ge logis ical challenge o accessing mo e emo e schools and because hey ha e su icien echnical in as uc u e (such as adequa e Wi-Fi ne wo k s abili y) o ca y ou he p ojec . Th ee o he cen es a e in he subu bs o he Depa men o Gua emala, and wo a e in he Municipali y o Villa Nue a. All o hem a e in colonias (neighbou hoods) cha ac e ized by low socioeconomic le el, agg a a ed by e y high exposu e o iolence; assaul s, dea hs, and ex o ions a e daily si ua ions in hese communi ies, which makes hem especially ulne able a eas. Be ween hese i e cen es, he e a e app oxima ely 1400 5 h g ade child en en olled. E e y child ha e o p o ide o al consen o pa icipa e in his s udy, and hei legal gua dians mus sign an in o med consen documen allowing he use o collec ed da a o esea ch pu poses, a e being ex ensi ely b ie ed abou he goals, me hods, and po en ial bene i s o pa icipa ion ( his documen was p o ided by he esea ch eam and can be seen in he Supplemen a y Ma e ials). 2.1.3. Sample Size To ensu e ha he size o he imp o emen s ealized by he in e en ion a e o p ac ical signi icance, we p opose a minimum e ec size o Cohen’s d= 0.3, which is a small- o- medium e ec . A powe calcula ion using his e ec size and he p oposed analysis plan (see below) was ca ied ou using he p og am G*Powe [ 35 ] and indica ed ha he minimum sample size we equi e o he s udy is n = 352. Howe e , due o he di icul li ing condi ions in he p oposed ec ui men a eas (gang iolence, long dis ances om esidences o school cen es, e c.), we expec a high d opou a e. The e o e, we p opose o ec ui a o al o 480 child en as his would allow o sligh ly mo e han 25% o he sample o s op pa icipa ion in he s udy ye s ill allow us o main ain su icien s a is ical powe o de ec he a ge e ec size. Fu he mo e, he igu e o 480 ep esen s app oxima ely one- hi d o 5 h g ade s uden s a ending Fe y Aleg ía Gua emala ac oss hei 46 cen es. Thus, we would only need consen om one in e e y h ee child en o achie e he necessa y sample size. This sample size could be educed i esea ch eams we e p epa ed o look o la ge e ec sizes. Fu he mo e, once his p o ocol is implemen ed, esea ch g oups should conside c ea ing a con ingency plan based on he speci ic condi ions hey encoun e o add ess po en ial di icul ies in ec ui men . 2.2. Objec i es and Hypo hesis The main objec i e o his s udy p o ocol is o imp o e he cogni i e pe o mance and emo ional compe ence o s uden s a isk o social exclusion in ulne able a eas o Gua emala (due o hei high exposu e o iolence and low socioeconomic le el) and consequen ly imp o e hei academic pe o mance, psychological adjus men , and quali y o li e. The speci ic objec i e is he de elopmen o a comp ehensi e neu opsychological s imula ion p og am in which he ollowing cogni i e and emo ional unc ions a e a ge ed: a en ion, language, execu i e unc ions, social cogni ion, and emo ional compe ence. This comp ehensi e in e en ion esponds o he needs iden i ied in ou p e ious s udies, and we hypo hesize ha s eng hening cogni i e abili ies and emo ional compe ence will imp o e o e all heal h and well-being, as p e ious s udies ha e shown [25–27]. 2.3. Ins umen s 2.3.1. Comp ehensi e Assessmen Ba e y To ob ain he baseline da a o he pa icipan s and e alua e hei subsequen cogni i e and emo ional pe o mance a e he in e en ion, we will use a ba e y o neu opsycho- logical es s o assess he cogni i e domains o language [ 36 – 38 ]: a en ion [ 39 ], execu i e Heal hca e 2024,12, 596 5 o 13 unc ions [ 40 – 44 ], and social cogni ion [ 45 ]. We will also assess hei men al heal h [ 46 , 47 ], emo ional managemen [ 48 ], and quali y o li e [ 49 ]. Las ly, we will ake measu emen s o hei amily’s socioeconomic le el, clinical his o y, ood consump ion [ 50 ], exposu e o iolence [ 51 ], and academic pe o mance ( o de ailed explana ions o he assessmen ins umen s, see Supplemen a y Ma e ials). In o al, he e will be ou assessmen sessions, each las ing be ween 45 and 60 min. The session plan has been designed in a modula way ha allows o lexible adminis a ion in o de o accommoda e pa icipan s who canno a end he educa ional cen e on a daily basis. Each module can be assessed in any o de , and hey can be applied one a e he o he wi hin he same session (p o iding b eaks in be ween), al hough assessing each module on di e en days would be ideal. Gi en he la ge numbe o es s ha will be equi ed o a comp ehensi e assessmen , i will become di icul o compa e esul s ac oss es s. Fo his eason, con e ing esul s o pe cen iles o z-sco es will need o be pe o med in o de o make meaning ul compa isons be ween ins umen s. 2.3.2. Cogni i e and Emo ional In e en ion P og am The in e en ion p og am will be ca ied ou using able s wi h access o he digi al neu o ehabili a ion pla o m Neu onUP [ 52 ], a ool o neu opsychological ehabili a ion, s imula ion, and session managemen ool [ 53 – 55 ]. Compu e ized neu opsychological in e en ions a e an al e na i e o he classic pencil and pape asks ha o e pa ien s a no el and en e aining way o ain hei cogni i e skills. These in e en ions ha e been in e na ionally alida ed [ 56 – 61 ]. The sessions hemsel es will be di ided in o 30 min o s imula ion ime and 15 min o dis ibu ing he able s a he beginning, logging in o he s uden s’ accoun s, and collec ing hem a he end. Since he s imula ion p og am will be ca ied ou h ough he use o his app, he e a e no associa ed heal h isks o he pa icipan s; i is a non-in asi e me hod o cogni i e s imula ion p epa ed o p omo e pa icipan engagemen and educe us a ion by p esen ing exe cises as mini-games. The sessions will be p og ammed by specialis s in neu opsychology om he esea ch eam using he Neu onUP2GO unc ionali y, an online applica ion ha allows o managing he s imula ion sessions o use s loca ed anywhe e a ound he wo ld. Remo e moni o ing p o ides con inuous con ol, hanks o he ac ha all ac i i ies and esul s a e s o ed on he pla o m i sel . In addi ion, using Neu onUP2GO, p o essionals can adap sessions based on he p og ess o each use , hus achie ing a con olled and pe sonalized in e en ion. The s imula ion p og am will aim o ain he pa icipan s in ac i i ies a ge ing a en ion, language, execu i e unc ions, and social cogni ion in a cyclical manne , dedica ing each day o a speci ic domain. Ac i i ies will be di e en in e e y session o a oid bo edom. Howe e , hey will be aining he same cogni i e domains, so pa icipan s a e able o wo k on imp o ing hem a a simila pace. The p og am will also ha e h ee le els o di icul y (easy, medium, and ha d) ha will inc ease in di icul e e y wo cycles, so he s uden s ha e ime o adap o hei cu en di icul y le el wi hou being ushed. The e will be wo ac i i ies o each cogni i e skill a e e y di icul y le el (see Figu e 1). This also makes i possible o apply he p og am in a lexible way o en i e class g oups in which he e a e usually small di e ences in age as well as di e en a es o de elopmen and special needs. Addi ionally, i allows child en who ake longe o adap he ime hey need o de elop he in ended capabili ies g adually, while p o iding e e y child he same le el o s imula ion, so he whole class can keep s eady p og ess. The adminis a ion o able s o pa icipan s in each session will be ca ied ou by pe sonnel, duly ained and appoin ed by he managemen eam o he educa ional cen es (no mally academic u o s o hose esponsible o he compu e a ea), wi h pe iodic supe ision by neu opsychology and educa ional psychology specialis s om he p ojec in case any p oblems o ques ions a ise. The i s session will include an ini ial p esen a ion in which p o essionals ins uc pa icipan s on how o ope a e he able s and he app, making i sligh ly longe han o he sessions. A pilo ial has al eady been ca ied ou wi h Gua emalan child en om hese schools o adap he ac i i ies cul u ally and linguis ically. A eam o Gua emalan Heal hca e 2024,12, 596 6 o 13 and Spanish neu opsychology expe s and na i e eache s e iewed child en’s eedback om his pilo and, wi h he help o Neu onUP s a , made necessa y adjus men s o he ac i i ies selec ed o he p og am o ensu e cul u al and linguis ic adap a ion o Gua emalan child en. Heal hca e 2024, 12, x FOR PEER REVIEW 6 o 13 Figu e 1. S imula ion p og am, session by session. No e. The names o e e y ac i i y in Neu onUp can be seen du ing each session. In some sessions, pa icipan s will engage in mo e han one ac i - i y, depending on he leng h o each ac i i y. The abb e ia ions lis ed alongside he session num- be e e o: A .: A en ion (o ange), L.: Language (blue), EF.: Execu i e Func ioning (g een), SC.: Social Cogni ion (pink). This also makes i possible o apply he p og am in a lexible way o en i e class g oups in which he e a e usually small diffe ences in age as well as diffe en a es o de elopmen and special needs. Addi ionally, i allows child en who ake longe o adap he ime hey need o de elop he in ended capabili ies g adually, while p o iding e e y child he same le el o s imula ion, so he whole class can keep s eady p og ess. The ad- minis a ion o able s o pa icipan s in each session will be ca ied ou by pe sonnel, duly ained and appoin ed by he managemen eam o he educa ional cen es (no mally ac- ademic u o s o hose esponsible o he compu e a ea), wi h pe iodic supe ision by neu opsychology and educa ional psychology specialis s om he p ojec in case any p oblems o ques ions a ise. The i s session will include an ini ial p esen a ion in which p o essionals ins uc pa icipan s on how o ope a e he able s and he app, making i sligh ly longe han o he sessions. A pilo ial has al eady been ca ied ou wi h Gua e- malan child en om hese schools o adap he ac i i ies cul u ally and linguis ically. A eam o Gua emalan and Spanish neu opsychology expe s and na i e eache s e iewed child en’s eedback om his pilo and, wi h he help o Neu onUP s aff, made necessa y adjus men s o he ac i i ies selec ed o he p og am o ensu e cul u al and linguis ic ad- ap a ion o Gua emalan child en. The e a e se e al bene i s ha he in e en ion may b ing o pa icipan s. They will engage in a ound one hou pe week o digi al exe cises c ea ed o s imula e and s eng hen cogni i e unc ions and emo ional managemen . These unc ions a e essen ial o p ope child de elopmen and ha e a signi ican impac on hei social and academic pe o mance. I is impo an o ou line he ac ha his s udy will no ha e a passi e con- ol g oup, as i is pa o a bigge in e na ional coope a ion p ojec conduc ed by he ounding o ganiza ion ocused on p o iding heal h and educa ional se ices o ulne a- ble popula ions, equi ing all child en o ecei e some kind o in e en ion. The con ol g oup will use he ime dedica ed o in e en ion sessions o ca y ou a eading mo i a- ion p og am ha is egula ly used in hese schools (a “ he apy as usual” con ol g oup). This p og am has been p oposed by Fe y Aleg ía o ain eading p o iciency while ex- plo ing a a ie y o opics, such as gende equali y, sexuali y, and many o he social op- ics. They will also pe o m egula academic ac i i ies ha he esponsible eaching s aff conside pe inen . This s udy will con ibu e o imp o ing he li ing condi ions o Gua emalan child en h ough inno a i e ac ions designed o espond o he speci ic needs o child en in ul- ne able con ex s. Ini ially, he p e ious s udy on socioeconomic s a us and cogni i e Figu e 1. S imula ion p og am, session by session. No e. The names o e e y ac i i y in Neu onUp can be seen du ing each session. In some sessions, pa icipan s will engage in mo e han one ac i i y, depending on he leng h o each ac i i y. The abb e ia ions lis ed alongside he session numbe e e o: A .: A en ion (o ange), L.: Language (blue), EF.: Execu i e Func ioning (g een), SC.: Social Cogni ion (pink). The e a e se e al bene i s ha he in e en ion may b ing o pa icipan s. They will engage in a ound one hou pe week o digi al exe cises c ea ed o s imula e and s eng hen cogni i e unc ions and emo ional managemen . These unc ions a e essen ial o p ope child de elopmen and ha e a signi ican impac on hei social and academic pe o mance. I is impo an o ou line he ac ha his s udy will no ha e a passi e con ol g oup, as i is pa o a bigge in e na ional coope a ion p ojec conduc ed by he ounding o ganiza ion ocused on p o iding heal h and educa ional se ices o ulne able popula ions, equi ing all child en o ecei e some kind o in e en ion. The con ol g oup will use he ime dedica ed o in e en ion sessions o ca y ou a eading mo i a ion p og am ha is egula ly used in hese schools (a “ he apy as usual” con ol g oup). This p og am has been p oposed by Fe y Aleg ía o ain eading p o iciency while explo ing a a ie y o opics, such as gende equali y, sexuali y, and many o he social opics. They will also pe o m egula academic ac i i ies ha he esponsible eaching s a conside pe inen . This s udy will con ibu e o imp o ing he li ing condi ions o Gua emalan chil- d en h ough inno a i e ac ions designed o espond o he speci ic needs o child en in ulne able con ex s. Ini ially, he p e ious s udy on socioeconomic s a us and cogni i e de elopmen has allowed us o iden i y he a eas ha need g ea e ein o cemen [ 21 ]. The e o e, he exe cises de eloped using able s, which ha e al eady p o en o be suc- cess ul in o he con ex s, will be adap ed o he needs o he g oup wi h which we will wo k. In addi ion, he p e ious s udy has ound anxie y and dep ession symp oms ha a e highe han expec ed and highe han he a e age, especially in u ban–ma ginal sec o s. Fo his eason, ac ions o s eng hen emo ional in elligence a e included. E idence shows ha , in addi ion o imp o ing concen a ion and academic pe o mance, his ype o in e - en ion p omo es he p e en ion o he appea ance o iolen , addic i e beha iou s, and o he beha iou s associa ed wi h impulsi eness and di icul y in long- e m planning, hus con ibu ing o pe sonal and collec i e empowe men o hese child en [27,29,30]. 2.4. P ocedu e The design o his s udy p o ocol ollows he guidelines o he CONSORT- e ised ecommenda ions o imp o ing he quali y o epo s o pa allel g oup andomized Heal hca e 2024,12, 596 7 o 13 ials [ 62 ]. The s udy has been p e- egis e ed wi h he Open Science Founda ion. Ideally, child en should be andomly alloca ed o ei he he con ol o he expe imen al g oup. Howe e , implemen a ion o his p o ocol equi es he use o a leas wo ooms a he same ime, along wi h a high le el o logis ical o ganiza ion in e ms o mo ing he child en o hei co ec ooms o each session. Gi en he na u e o he schools in ol ed, we do no belie e i is ealis ic o expec ha hese esou ces will always be a ailable. Hence, we p opose ha he s udy will be ca ied ou h ough a mul icen e andomized con olled ial in which en i e classes o child en will be assigned o ei he he con ol o expe imen al condi ions. We no e, howe e , ha he membe s o each class a e alloca ed a andom by he school as hey en oll, so in his sense, andom alloca ion a he pa icipan le el is s ill somewha achie ed. To minimize po en ial bias ela ed o school-speci ic ac o s, each school will p o ide [a leas ] wo classes, hus ensu ing ha each school is ep esen ed in bo h condi ions. E o s should be made o ensu e as close o a 1:1 a io o s uden s be ween g oups as possible. The class designa ed as he expe imen al g oup will ecei e he in e en ion. The second g oup will be made up o he s uden s who will o m he con ol g oup. A c osso e design will be used in which he ole o each g oup is e e sed du ing he ollowing academic yea , hus ensu ing ha each child has he oppo uni y o bene i om he in e en ion p og am. The s udy will he e o e be di ided in o wo blocks (see Figu e 2). The i s block will occu in yea 1 and will consis o a p io and pos e io assessmen (T1 and T2) o he child en’s cogni i e and emo ional abili ies and he implemen a ion o he in e en ion p og am in be ween. The second block will occu in yea 2 and will consis o a second in e en ion, ollowed by a inal assessmen (T3), which will occu when he child en a e in he 6 h g ade. In his block, he con ol and expe imen al g oups will change oles. Apa om ensu ing ha all child en may bene i om he in e en ion p og am, i will p o ide an oppo uni y o de e mine i he e is main enance o he bene i s ob ained by he expe imen al g oup du ing he i s block. All assessmen s will be ca ied ou by p o essional neu opsychologis s and educa ional psychologis s, duly ained o adminis e he assessmen asks by he expe s om he esea ch eam. Heal hca e 2024, 12, x FOR PEER REVIEW 8 o 13 Figu e 2. C osso e design o he s udy. No e. Highligh ed in g ey boxes a e he expe imen al g oups (Exp.) o each ound on in e en ion. Whi e in e en ion boxes ep esen he con ol g oups (C l.). The p og am will ake place du ing he second hal o he academic yea , a a a e o wo sessions pe week, wi h an es ima ed du a ion o abou 45 min pe session. Pa ici- pan s will comple e he wo weekly sessions on diffe en days o he week, depending on he school hey a end, bu always wi h a leas one es day in be ween. I , o some ea- son, he e a e pa icipan s who miss one o he sessions, hey would ha e o eco e i du ing he same week o a oid he isk o alling behind hei classma es. I pa icipan s miss a session and canno eco e i wi hin he same week, hey will skip ha session and con inue wi h he no mal session planned o he ollowing week, bu he missed session will be egis e ed as los . The jus i ica ion o his decision is ha some imes access o schools o a s able in e ne connec ion will no be gua an eed in he con ex o he s udy. Hence, his p o ocol will p e en pa icipan s om lagging behind hei classma es and a oids ha ing pa icipan s comple ing diffe en sessions in he same class oom. An addi- ional eason o making his decision is ha a he end o he p og am, we will be able o analyze he pe cen age o comple ion o each pa icipan and de e mine he minimum comple ion pe cen age o ensu e he p og am’s effec i eness. One ad an age o he g oup sessions is ha many child en can bene i om p o es- sional in e en ion wi hou he need o ha e one he apis o each child. Ne e heless, child en wi h a p e iously diagnosed condi ion a e a isk o g ea e disad an age com- pa ed o hei coun e pa s and may need specialized, one-on-one a en ion. We do no p opose ha hese child en be excluded om he in e en ion. Howe e , wi h he help Fe y Aleg ía, an al e na i e in e en ion will be offe ed o amilies ha wish o ecei e addi- ional suppo by e e ing hem o specialized se ices offe ed o people wi h limi ed economical possibili ies. Fu he mo e, eache s will be p o ided wi h aining o effec- i ely aid and suppo hese s uden s wi hin he school. 2.5. Da a Managemen and Analysis Plan All physical ma e ials, such as answe shee s, hand-w i en esponses o he es s, and in o med consen o iginals, will be s o ed and sa egua ded a Fe y Aleg ía headqua - e s in Gua emala. The da a ga he ed om he assessmen s will be ansc ibed in o com- pu e iles, which will be s o ed in secu e online se e s a Loyola Andalucía Uni e si y and will only be accessed by au ho ized pe sonnel om he esea ch p ojec . This da a will be compiled and analyzed by he echnicians and esea ch assis an s collec ing he in o ma ion, supe ised by he senio membe s o he esea ch eam unc ioning as a s ee ing g oup. E e y pa icipan will be assigned an iden i ica ion numbe so hei da a can be compiled and analyzed anonymously, ollowing he O ganic Law on Pe sonal Da a Figu e 2. C osso e design o he s udy. No e. Highligh ed in g ey boxes a e he expe imen al g oups (Exp.) o each ound on in e en ion. Whi e in e en ion boxes ep esen he con ol g oups (C l.). The p og am will ake place du ing he second hal o he academic yea , a a a e o wo sessions pe week, wi h an es ima ed du a ion o abou 45 min pe session. Pa icipan s will comple e he wo weekly sessions on di e en days o he week, depending on he school hey a end, bu always wi h a leas one es day in be ween. I , o some eason, he e a e pa icipan s who miss one o he sessions, hey would ha e o eco e i du ing he same week o a oid he isk o alling behind hei classma es. I pa icipan s miss a session and canno eco e i wi hin he same week, hey will skip ha session and con inue wi h he no mal session planned o he ollowing week, bu he missed session will be Heal hca e 2024,12, 596 8 o 13 egis e ed as los . The jus i ica ion o his decision is ha some imes access o schools o a s able in e ne connec ion will no be gua an eed in he con ex o he s udy. Hence, his p o ocol will p e en pa icipan s om lagging behind hei classma es and a oids ha ing pa icipan s comple ing di e en sessions in he same class oom. An addi ional eason o making his decision is ha a he end o he p og am, we will be able o analyze he pe cen age o comple ion o each pa icipan and de e mine he minimum comple ion pe cen age o ensu e he p og am’s e ec i eness. One ad an age o he g oup sessions is ha many child en can bene i om p o es- sional in e en ion wi hou he need o ha e one he apis o each child. Ne e heless, child en wi h a p e iously diagnosed condi ion a e a isk o g ea e disad an age com- pa ed o hei coun e pa s and may need specialized, one-on-one a en ion. We do no p opose ha hese child en be excluded om he in e en ion. Howe e , wi h he help Fe y Aleg ía, an al e na i e in e en ion will be o e ed o amilies ha wish o ecei e addi ional suppo by e e ing hem o specialized se ices o e ed o people wi h limi ed economical possibili ies. Fu he mo e, eache s will be p o ided wi h aining o e ec i ely aid and suppo hese s uden s wi hin he school. 2.5. Da a Managemen and Analysis Plan All physical ma e ials, such as answe shee s, hand-w i en esponses o he es s, and in o med consen o iginals, will be s o ed and sa egua ded a Fe y Aleg ía headqua e s in Gua emala. The da a ga he ed om he assessmen s will be ansc ibed in o compu e iles, which will be s o ed in secu e online se e s a Loyola Andalucía Uni e si y and will only be accessed by au ho ized pe sonnel om he esea ch p ojec . This da a will be compiled and analyzed by he echnicians and esea ch assis an s collec ing he in o ma ion, supe ised by he senio membe s o he esea ch eam unc ioning as a s ee ing g oup. E e y pa icipan will be assigned an iden i ica ion numbe so hei da a can be compiled and analyzed anonymously, ollowing he O ganic Law on Pe sonal Da a P o ec ion and Gua an ee o Digi al Righ s 3/2018. I , a he ime o da a analysis, any po en ial isks o he pa icipan s’ men al heal h a e ound by he esea che s, an unblinding p ocedu e will ake place o iden i y he pa icipan s and no i y hei school cen e so hey can ake any ac ions deemed necessa y wi h said child en and hei amilies. The unding body will unde go an audi ing p ocess in he middle and a he end o he s udy o ensu e ha he planned in e en ions a e p ope ly ca ied ou . P e/pos -e alua ion da a a e bes analyzed using an ANCOVA design in which pos -sco es a e he dependen a iable, and p e-sco es se e as he co a ia e [ 63 ]. This will be conduc ed sepa a ely o each in e en ion, wi h he da a collec ed a T2 se ing as pos -da a o in e en ion 1 and p e-in e en ion baseline da a o in e en ion 2. I desi ed, he e ec s o he wo in e en ions can be di ec ly compa ed by implemen ing a epea ed measu es ANCOVA. Gi en ha i is likely ha aw sco es will be con e ed o and analyzed as pe cen ile sco es, no mal dis ibu ions o he dependen a iables may no be p esen . Acco dingly, Boo s apping o non-no mal dis ibu ions in he Gene alized Linea F amewo k should be conside ed o accommoda e hese da a. O he co a ia es, such as sex, age, mean educa ional le el o pa en s, e c., can be included in he analyses. I will also be possible o pe o m analyses o di e en subg oups o pa icipan s, ei he using mul ile el, s a i ied models, o by sepa a ing ou he subg oups, depending on he speci ic na u e o he subg oups. In pa icula , we will explo e he di e ences be ween he “no ma i e” g oup (pa icipan s be ween he ages o 10 and 12, wi hou any clinical diagnosis and wi h sco es o e he inclusion limi in he sc eening assessmen asks), and he “non-no ma i e” g oup (pa icipan s 13 yea s old and abo e, ha ing any clinical diagnosis, o wi h sco es unde he sc eening asks limi ). This las sepa a ion will be pe o med o explo e he impac he p og am may ha e on child en wi h addi ional di icul ies. We will pe o m ano he ANCOVA analysis o explo e he long- e m changes in he pa icipan s a he end o he p og am (second block), conside ing he changes hey migh ha e expe ienced on he i s block. Whe e mul iple compa isons a e unde aken due o he p esence o Heal hca e 2024,12, 596 9 o 13 many schools, age anges, o o he ac o s, app op ia e co ec ions will be applied o he s a is ical es s. Since all child en will ecei e he in e en ion, we wan o explo e he e ec s his p og am may ha e on he child en who do no mee he inclusion c i e ia bu usually ha e special educa ional needs. Due o he na u e o he in e en ion, i is impossible o implemen i in a manne ha allows bo h pa icipan s and he pe sonnel adminis e ing he in e en ion o pa icipa e blindly. Howe e , he pe sonnel om he esea ch eam assessing he da a will be blinded o g oup assignmen o ensu e as much o an unbiased ou come as possible. The in e p e a ion o he da a will also ha e o conside he g oup assignmen o conclude he e icacy o he p og am. 3. Discussion This s udy p o ocol ocuses on imp o ing he cogni i e and emo ional compe ence o s uden s om especially ulne able a eas o Gua emala Ci y and consequen ly aims o imp o e hei academic pe o mance and quali y o li e. In addi ion, as he pa icipan s a e mino s li ing in e y ad e se socioeconomic condi ions, hey will ha e he oppo uni y o lea n how o use elec onic de ices ha hey would no no mally ha e access o, such as able s o i ual eali y headse s. Gi en he ecen si ua ion wi h he COVID-19 pan- demic, his knowledge can be bene icial o e ec i ely acing he educa ional challenges ha schools cu en ly ace a e wo yea s o non- egula ized schooling. The p og am is ambi ious in e ms o he numbe o es s i p oposes o include. Ne e heless, when eplica ing his s udy, each esea ch g oup can choose o a y he numbe o es s based on hei pa icula esea ch goals and he speci ic condi ions encoun e ed wi hin hei sample, and as he in e en ion p og esses. The e is a g ea educa ional gap among s uden s caused by he wildly a ied si ua ions in hei homes. The closu e o schools due o he COVID-19 eme gency has widened his gap, as mos o hese ulne able s uden s do no ha e access o compu e s o he in e ne in hei amily homes. In addi ion, he low le el o educa ion o hei ela i es and he ac ha hey end o li e in small and o e c owded houses ha e a signi ican impac on hei academic pe o mance. The in oduc ion o able s has he seconda y bene i o making i possible o educe he digi al gap be ween households while s eng hening he capaci y o eaching eams o design dis ance and ace- o- ace mixed educa ion me hod- ologies ha inc ease he skill le els o s uden s, hus educing he educa ional gap. An equi able educa ion is undamen al o exe cising igh s and inc easing oppo uni ies in he long- e m. I he esul s o his p oposed p og am success ully achie es he expec ed impac , i could make a big di e ence in he u u e o hese child en, p o iding hem wi h a chance o de elop hei cogni i e and social abili ies o p e iously unachie able le els, balancing he playing ield wi h o he child en o hei age. This p og am has been c ea ed o be applied in simila low-le el socioeconomic con ex s, which means ha i could become a eliable ool o help child en in simila condi ions a ound he wo ld, as he li e a u e sugges s [ 27 , 29 , 30 ]. I he p og am is e ec i e, he e a e plans o ans e he knowledge de i ed om he applica ion o he comp ehensi e neu opsychological s imula ion p o- g am in ulne able a eas o Gua emala o pa icula ly disad an aged con ex s in Andalucía (Sou he n Spain), whe e 15 o i s neighbou hoods a e among he poo es in Spain, based on he mos ecen epo o U ban Indica o s (U ban Audi ) published by he Na ional Ins i u e o S a is ics [64]. 4. Conclusions The long- e m goal o his p ojec is o c ea e a es ed and alida ed cogni i e s imu- la ion p og am, so ha i can be in eg a ed in o he academic cu iculum o educa ional cen es ha wo k wi h people belonging o his ype o popula ion. I is in ended o be implemen ed by he eaching s a o hese cen es and supe ised in pa allel by neu- opsychology p o essionals h oughou he p ocess. I aims o o e child en who li e in