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Early Development of Academic Skills in the Classroom (JAPI)

10 febbraio 2022 aggiornato da: Cristián A. Rojas-Barahona, University of Talca

Early Development of Academic Skills in the Classroom: Short- and Mid-term Effects of a Tablet-based Game That Stimulates Cognitive, Emotional, and Social Skills for Pre-kindergarten Children

This is a two-arm cluster randomized controlled trial. The two arms will be: 1) Intervention group, where the stimulation program will be implemented; and 2) Comparison group (active).

The aim of this study is: To evaluate the effectiveness of a program aimed at stimulating cognitive (working memory and inhibitory control), emotional (emotion recognition), and social competence skills (choice of prosocial behaviors) for the development of initial literacy learning and pre-calculation in socioeconomically disadvantaged preschoolers immediately after the intervention and at 6, 12, 18, and 24 months post intervention, controlling for gender, mental health, and baseline state of the skills stimulated.

The intervention program, which targets cognitive, emotional, and social competence skills, was designed for socioeconomically disadvantaged preschoolers in order to stimulate their working memory, inhibitory control, emotion recognition, and choice of prosocial behaviors during the development of the academic skills of initial literacy learning and pre-calculation. Immediately after the completion of the intervention program, participants are expected to show improvements in these skills and the academic skills of initial literacy learning and pre-calculation.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

General background information:

The literature suggests that children born to low-income families can begin the preschool stage with less developed academic skills (such as pre-calculation and initial literacy learning) and non-academic skills (such as emotional and social competence) compared to children from higher-income families. These differences appear to increase socioemotional, educational, and health-related disparities in the long term. Furthermore, the available evidence indicates that several landmarks of human development take place between 3 and 7 years of age, including the emergence of emotion recognition, control over one's behavior, and executive functions. Therefore, it is essential to work with children who are more economically vulnerable, stimulating these skills at an early age.

Working memory and inhibitory control (executive functions) have been identified as key components in the development of academic skills such as early literacy learning and pre-calculation, with evidence that participants can be stimulated at an early age. Furthermore, a meta-analysis conducted by Blewitt et al. (2018), which examined programs for children aged 2 - 6 years, found that children exposed to social and emotional stimulation programs exhibited significant improvements in social and emotional competences, learning outcomes, and behavioral regulation, while their emotional and behavioral problems were reduced. Several skill-building initiatives aimed at children which involve the use of tactile devices have been reported. For example, Herodotou (2017) conducted a systematic review in order to examine how using tactile screen devices impacted on the learning of children aged 2 to 5 years, finding that most studies evaluated cognitive aspects and largely overlooked socioemotional aspects. However, to the best of our knowledge, no effectiveness evaluations of a program combining cognitive and socioemotional stimulation have been conducted, let alone of a tablet-based program for preschoolers that involves mid-term follow-up.

Specific background information:

Several successful experiences of early cognitive skill stimulation exist, including COGMED for children with ADHD aged 7-17 years (Klingberg et al., 2005) and Memory Booster for children aged 5-8 years (St Clair-Thompson et al., 2010). Examples of socioemotional skill stimulation include PATHS, which involves verbalizing feelings and the usage of self-control strategies. However, our search yielded no effectiveness evaluations of a program combining cognitive and socioemotional stimulation, let alone of a tablet-based program for preschoolers featuring mid-term follow-up. The experience of our research team stems which found results favoring the intervention group in children aged 4-5 years (with a delta greater than 10%), both when stimulating working memory (Rojas-Barahona et al., 2015) and inhibitory control and planning (Rojas-Barahona et al., 2021). The intervention was conducted using a tablet computer in establishments with a high index of school vulnerability (ISV; Spanish: índice de vulnerabilidad escolar, IVE). Therefore, there is evidence in Chile, with socioeconomically disadvantaged preschool-age children, showing that the stimulation of cognitive skills (such as executive functions: working memory and inhibitory control) improves cognitive development and academic skills such as initial literacy learning and pre-calculation. In this context, the aim of this study is to determine the effectiveness of a program that jointly stimulates the cognitive and socioemotional skills of preschoolers in order to boost the development of their academic skills, controlling for gender, mental health, and baseline skills.

Objective of the project:

- To evaluate the effectiveness of a program aimed at stimulating cognitive (working memory and inhibitory control), emotional (emotion recognition), and social competence skills (choice of prosocial behaviors) for the development of initial literacy learning and pre-calculation in socioeconomically disadvantaged preschoolers immediately after the intervention and at 6, 12, 18, and 24 months post intervention, controlling for gender, mental health, and baseline state of the skills stimulated.

Specific objectives Objective 1. To determine the acceptability and ease of use of a program for stimulating cognitive (working memory and inhibitory control), emotional (emotion recognition), and social competence skills (choice of prosocial behaviors) in socioeconomically disadvantaged preschoolers.

Objective 2. To evaluate the changes observed in the variables working memory, inhibitory control, emotion recognition, and choice of prosocial behaviors in both the intervention and the comparison group immediately after the intervention and at 6, 12, 18, and 24 months post intervention.

Objective 3. To determine the effectiveness of a program aimed at stimulating cognitive (working memory and inhibitory control), emotional (emotion recognition), and social competence skills (choice of prosocial behaviors) for the development of initial literacy learning in socioeconomically disadvantaged preschoolers immediately after the intervention and at 6, 12, 18, and 24 months post intervention, controlling for gender, mental health, and baseline state of the skills stimulated.

Objective 4. To determine the effectiveness of a program aimed at stimulating cognitive (working memory and inhibitory control), emotional (emotion recognition), and social competence skills (choice of prosocial behaviors) for the development of pre-calculation in socioeconomically disadvantaged preschoolers immediately after the intervention and at 6, 12, 18, and 24 months post intervention, controlling for gender, mental health, and baseline state of the skills stimulated.

Objective 5. To explore the influence of potential mediators (working memory, inhibitory control, emotion recognition, and choice of prosocial skills) on the observed effects of a program for stimulating cognitive (working memory and inhibitory control), emotional (emotion recognition), and social competence skills (choice of prosocial behaviors), controlling for gender, mental health, and baseline status of the skills stimulated.

Methodology:

Design: A quantitative methodology will be employed, with a two-arm cluster randomized controlled trial design. The two arms will be: 1) Intervention group, where the stimulation program will be implemented; and 2) Comparison group (active). Investigators will establish the explanatory capacity of the independent variables -belonging to the intervention or comparison group- on the dependent variables -development of academic skills (initial literacy learning and pre-calculation)- (main outcome). The team will also consider the following as variables that mediate the effect of the intervention: working memory, inhibitory control, emotion recognition, and ability to select prosocial behaviors. Investigators will perform 1 measurement before the stimulation (pre) and 5 post measurements: immediately after the stimulation and at 6, 12, 18, and 24 months.

Participants: Our sample will comprise co-educational schools that serve preschool-age children located in two cities of the region (Talca and Linares), which have at least two classes per level, and which have an ISV ≥70%. Investigators will randomly select 20 schools in Talca and Linares proportionally to the size of each city's population. Then, schools' principals will be invited to participate. The first 18 institutions that agree will enter the study. The remaining schools that agree to participate will be placed on a waiting list in case any others withdraw from the study or encounter any difficulties (for details, see "Sample size"). Once the schools have been recruited, children will be randomly distributed at a 1:1 ratio through a computerized procedure. A statistician unaffiliated to the research team will conduct the randomization procedure. Afterwards, investigators will invite pre-kindergarten educators and assistants to join the study (together with kindergarten and 1st grade educators, as part of the longitudinal study). Then, during a parent-teacher conference, investigators will invite all the parents and guardians in these classes to allow their children to participate in the study. All three groups of participants (principals, educators and assistants, and parents) will need to sign an informed consent form. All the children authorized to do so will participate in the study; however, the analyses will not consider the data provided by children with cognitive disabilities (with a prior diagnosis). Also, children will need to give their informed assent to participate in the study. Even if their parents have given their consent, any child who does not wish to participate will not be compelled to do so.

Sample size: To determine a significant difference (alpha =0.05) in the measurement of the main result (academic skills: early literacy learning/pre-calculation) between the Comparison and Intervention groups with a statistical power of 80%, the research needs to recruit 6 schools with a total of 264 students per group, with an average of 44 students per school (divided into two classes). Sample size was calculated using the Stata statistical package and the "clustersampsi" command, which makes it possible to identify differences between groups relative to an average score and considers the effect of correlation among subjects within a school by means of the intracluster correlation coefficient. The information used to feed this equation was taken from a prior study (Rojas-Barahona et al., 2015) where the control group, at post-intervention, scored 20.06 for the variable early literacy learning (SD = 8.32). The sample size for this study was calculated assuming a 0.4 SD difference in favour of the intervention group. Estimating that 10% of the eligible students may not want to participate and estimating a 20% loss during follow-up, each group should recruit 377 students initially. This means that the team needs to recruit 9 additional schools per group, for a total of 18 schools.

Description of the groups

-Intervention Group: the intervention will be delivered through a tablet computer game that stimulates cognitive (working memory and inhibitory control), emotional (emotion recognition), and social competence skills (selection of prosocial behaviors). The intervention will be conducted individually in classroom settings; that is, each child will play on a tablet with headphones during 20 sessions lasting 30 minutes each, 2 times per week (2 and a half months in total) (Rojas-Barahona et al., 2015). At the end of the activity, each child will receive a sticker for their participation. The program has been gradually constructed using scientific evidence and is designed for one classroom period (15 minutes of instructions and closing, and 30 of direct play). All the activities are games with the following structure: an introduction with instructions and protagonist selection (an avatar who talks directly to the child and whose hair color, skin color, and clothes can be modified), followed by a practice exercise to ensure that the children understand what participants have to do (the exercise is repeated until the child performs it correctly), and, finally, the activity itself (4 different activities with 5 tries each). The first 10 sessions jointly stimulate working memory and emotion knowledge (4 activities focused on each skill per session), while the 10 remaining sessions stimulate inhibitory control and the selection of prosocial behaviors. The activities were constructed in previous projects by experts belonging to the research team. For example, in the working memory activities, the children receive phonological and visuo-spatial information and must recall this information in the same order that it was provided; in the inhibitory control activities, children must suppress automatic stimuli and processes; in the emotion recognition activities, kids must identify basic emotions; and in the selection of prosocial behaviors, and must choose an option to deal with a social problem. The intervention program covers some key ideas that any educational intervention aimed at preschoolers must consider a) Development and difficulty level: the activities will be structured from least to most difficult (a gradual approach to guarantee that all children will have a development-appropriate goal throughout the program; b) Variety of activities: each session features different activities; c) Short duration: the activities are short and dynamic; d) Achievable success: the program is constructed so that all children can succeed in their first attempts; e) Accessible and comprehensible instructions, with pertinent feedback (simple explanations with age-appropriate vocabulary and concepts); f) combination of play, practice, and learning (must have a ludic component, enabling children to practice until participants understand what must do before consolidating learning).

In this group, the educators will take part in 2 training sessions lasting 2 hours each in order to become familiar with the cognitive (working memory and inhibitory control), emotional (emotion recognition), and social skills (selection of prosocial behaviors) stimulated by the game, the functioning of the game, and its implementation in the classroom. Also, a meeting with all the educators will be held every 15 days to solve any doubts and evaluate the progression of the programs.

-Comparison group (active): The children will not work with the program for stimulating cognitive and socioemotional skills; however, over 20 sessions lasting 30 minutes each, 2 times per week, participants will play a tablet-based painting game that involves no cognitive, emotional, or social competence stimulation. At the end of the activity, each child will receive a sticker for their participation. In this group, the educators will receive the same training in cognitive, emotional, and social competence skills delivered to the intervention group. Children will also be trained in the use of the painting game, with meetings being held every 15 days to solve any doubts that might emerge. The similar treatment received by both groups is aimed at preventing teacher-dependent effects of the program. This knowledge will remain in place in each school for future studies in this field. All groups will be guided by the preschool educator in charge of the class and all the students will work at the same time (each child will have an individual tablet with headphones). All the children who wish to play will be able to participate (to avoid discrimination), however, only those who have their parents' consent and have given their assent will be able to do so. A member of the research team will be present in each session to ensure that it progresses adequately.

Instruments:

Each participant will be individually evaluated 6 times, 1 time before the intervention and 5 times after the intervention, using tasks focused on working memory, inhibitory control, emotion recognition, selection of prosocial behaviors, and pre-calculation and early literacy learning skills in 2 sessions lasting approximately 40 minutes each (with breaks throughout). The tasks will be administered at each school, in a quiet and controlled area. For their part, in the first months of each year, the parents will complete a questionnaire on the child's mental health (three times in total). The instruments used in the measurements were selected because: 1) tests have already been validated in Chile for small children (4 and 5 years of age) or are in the process of being validated by the team behind the present project, and 2) are in Spanish, are easy to use for small children, and are employed in research around the world.

Primary outcomes:

1- Tests of academic skills: 1.1- Initial literacy learning: Two tests will be used: Texas Lee, designed by the Texas Education Agency (2009) in collaboration with the University of Houston to evaluate reading in Spanish-speaking children. To evaluate vocabulary, the Spanish adaptation of the Kaufman Assessment Battery for Children (K-ABC) (Kaufman & Kaufman, 1997) will be used. Both were validated in Chile by Medina et al. (2011).

1.2- Pre-calculation skills: Woodcock-Muñoz (Battery III, Muñoz-Sandoval et al., 2005).

Control variable:

2. Mental health problems: Goodman's "Strengths and Difficulties Questionnaire" (SDQ) (1997) will be utilized. The version for children and young people in Chile was validated by some members of the present project (Gaete et al., 2018).

Potential mediators:

3. Tests of cognitive skills: 3.1. Working memory: For the visuo-spatial area, the "Corsi Cube test" (Corsi, 1972) will be administered. For the phonological area, the auditive memory subtest of Woodcock-Muñoz (Battery III, Muñoz-Sandoval et al., 2005) (internal consistency .80, Cizek, 2003) will be employed.

3.2 Inhibitory control: the "Hearts & Flowers" task (Diamond et al., 2007) will be used.

4. Tests of socio-emotional skills: 4.1. Emotion recognition: the "Assessment of Children's Emotional Skills" (ACES) by Shultz et al. (2004) will be administered. The test comprises 3 subscales: facial expressions, social situations, and social behavior. In the present project, the subscale of facial expressions (a =.68, Shultz et al., 2004) will be administered.

4.2 Selection of prosocial behaviors: the "Challenging Situations Task" (CST) by Denham et al. (1994) will be employed.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

754

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Cristian A. Rojas-Barahona, PhD
  • Numero di telefono: +56712201747
  • Email: c.rojas@utalca.cl

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 3 anni a 5 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Establishments with an index of school vulnerability (ISV) ≥70%. (Based on information provided by participating families).
  • Establishment that offers preschool and elementary education.
  • Establishment located in the region of Maule, Chile.
  • Co-educational School.
  • Classes with a minimum of 15 students each.

Exclusion Criteria:

  • School is implementing a similar program.
  • Special education school.
  • Children with a reported cognitive disability

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention group
The evaluator in charge will monitor the autonomous work of the participants during all 20 sessions of the program for stimulating cognitive and socioemotional skills while also answering questions, training the educators, and solving their doubts about the program and its implementation.
Each child will play on a tablet with headphones during 20 sessions lasting 30 minutes each, 2 times per week. All the activities are games with the following structure: an introduction with instructions and protagonist selection, followed by a practice exercise to ensure that the children understand what they have to do (the exercise is repeated until the child performs it correctly), and, finally, the activity itself (4 different activities with 5 tries each). The first 10 sessions jointly stimulate working memory and emotion knowledge (4 activities focused on each skill per session), while the 10 remaining sessions stimulate inhibitory control and the selection of prosocial behaviours. In the inhibitory control activities, they must suppress automatic stimuli and processes; in the emotion recognition activities, they must identify basic emotions; and in the selection of prosocial behaviours, they must choose an option to deal with a social problem.
Comparatore fittizio: Painting group
Each child will play on a tablet with headphones during 20 sessions lasting 30 minutes each, 2 times per week. They will play a tablet-based painting game that involves no cognitive, emotional, or social competence stimulation
Each child will play on a tablet with headphones during 20 sessions lasting 30 minutes each, 2 times per week. They will play a tablet-based painting game that involves no cognitive, emotional, or social competence stimulation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Texas Lee Test (Initial literacy learning)
Lasso di tempo: 1 month
An instrument designed to evaluate Initial literacy learning in Spanish-speaking children, validated for Chile and which considers the following dimensions: Book and Print Awareness (10 items), Phonological Awareness (12 items), Graphophonemic and phonological Knowledge (44 items), and Listening Comprehension (6 items). This test was designed for K1 to 3rd grade students.
1 month
Kaufman Assessment Battery for Children (K-ABC) (Vocabulary)
Lasso di tempo: 1 month
A measure of cognitive skill and academic knowledge used to evaluate the knowledge acquired and the level of school learning attained. This test was designed to evaluate children from 2 and a half to 12 and a half years old, in 4 dimensions: mental, sequential and simultaneous processing, and knowledge. The last one is the one will be used to measure vocabulary by 17 items.
1 month
subtest Battery III of Woodcock-Muñoz (Pre-calculation)
Lasso di tempo: 1 month
Pre-calculation skills using Battery III of Woodcock-Muñoz, which includes the following subtests: number identification (17 items), quantification (7 items), verbal counting (1 item), and applied problems (34 items). This test can be used to measure people from 5 to 95 years old.
1 month

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Strengths and Difficulties Questionnaire (SDQ) (Mental health problems)
Lasso di tempo: 1 month
A questionnaire comprising a set of emotional and behavioral problems experienced by children aged 4-16 years. It has 4 scales of psychological difficulties (with 5 items each): emotional symptoms, behavioral problems, hyperactivity/attention problems, problems among peers, and prosocial behavior.
1 month
Corsi Cube test (Visuo-spatial working memory)
Lasso di tempo: 1 month
This test requires repeating a sequence of up to nine identical blocks spatially separated on a screen which must be memorized for a short time to be repeated in the same order they were presented before or in the inverse order. The sequence is initially simple, but becomes more complex until the subject's performance starts decreasing. The test finishes if 2 consecutive errors are made in the same stage.
1 month
subtest of Battery III of Woodcock-Muñoz (Phonological working memory)
Lasso di tempo: 1 month
This test has 21 audio messages which contain numbers and words increasing the quantity and difficulty from lower to higher. Students are asked to remember and repeat these messages, if they fail 3 consecutive times the test ends.
1 month
Hearts & Flowers (Inhibitory control)
Lasso di tempo: 1 month
The task is a hybrid, combining elements from Simon and spatial tasks by Stroop, and contains congruent and incongruent trials which are organized in 3 parts and has a mean of 7 minutes of total duration.
1 month
Assessment of Children's Emotional Skills (ACES) (Emotion recognition)
Lasso di tempo: 1 month
The test comprises 3 subscales: facial expressions, social situations, and social behavior. In the present project, we will administer the subscale of facial expressions with 34 items in total. Students must recognize different emotions in photographs of school-age children.
1 month
Challenging Situations Task (CST) (Ability to select prosocial behaviors)
Lasso di tempo: 1 month
The instrument evaluates children's problem-solving skills. The participants will be shown 6 problems among peers and then the question "how would you feel?" being able to answer "happy", "sad", "mad", or "just fine" and mention what they would do. Their responses will be classified in four choices: prosocial, aggressive, crying, or avoidant.
1 month

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 marzo 2022

Completamento primario (Anticipato)

30 luglio 2022

Completamento dello studio (Anticipato)

30 marzo 2025

Date di iscrizione allo studio

Primo inviato

25 gennaio 2022

Primo inviato che soddisfa i criteri di controllo qualità

25 gennaio 2022

Primo Inserito (Effettivo)

4 febbraio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 marzo 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 febbraio 2022

Ultimo verificato

1 febbraio 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • FR 1210989

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

No share of individual participant data is planned because of restrictions provided by the Ethical Committee.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .