Deficits in emotion recognition and processing in children with high callous-unemotional traits: the role of the MAOA gene.

Children with high Callous-Unemotional (CU) traits show deficits in recognizing and processing facial expressions. Alterations in emotion recognition have been linked to a higher synaptic concentration of monoaminergic neurotransmitters. The current study investigated the relationship between the MAOA-Low-activity alleles and the ability to recognize and process facial expressions in 97 male children (8-12 years old) diagnosed with disruptive behavior disorder. Participants completed a computerized emotion-recognition task while an eye-tracking system recorded the number (Fixation Count, FC) and length (Fixation Duration, FD) of fixations to the eye region of the emotional stimuli. Children with high CU traits exhibited lower scores in recognition of sadness and anger, and lower FC and FD for sadness and fear than children with low CU traits. Children carrying the MAOA-Low-activity alleles displayed lower FD for sadness, and FD and FC for fear than those carrying the MAOA-High-activity alleles. These genetic effects appeared even stronger in children with CU traits. Moderation analysis revealed that CU traits were associated with lower FC and FD for fear, and lower FD for sadness, probably due to the MAOA-Low-activity alleles. Our findings, although to be replicated, suggest MAOA-Low-activity alleles as potential genetic biomarkers to identify CU children in need of training focused on emotion processing.

Sleep disturbances in specific learning disorders: a qualitative and quantitative investigation.

BACKGROUND: The literature reports a significant association between sleep disorders and learning disabilities. Nevertheless, not all children with learning disorders have sleep alterations, and which sleep characteristics are associated with which learning difficulty is still unknown. The study aimed at acquiring new information on the relation between sleep disturbances or habits and the learning profiles of children with a specific learning disorder (SLD). METHODS: The Sleep Disturbance Scale for Children (SDSC) and an actigraph (the FitBit-Flex, FB-F) were used in 26 and 16 SLD children respectively; all children were also assessed for learning skills. RESULTS: Although parents' reports at the SDSC did not differentiate SLD from typical readers, the awakening, respiratory and arousal disturbances at the SDSC correlated with sleep duration at the FB-F. Sleep alterations at the FB-F actigraph characterize SLD with literacy difficulties: children with reading decoding difficulties showed shorter minimum amount of sleep than typical children, and severe SLDs showed shorter maximum sleep duration and a higher number of awakenings in comparison to SLDs with mild learning deficits. CONCLUSIONS: Mild alterations in the amount, duration and quality of sleep may characterize children with learning disorders and actigraphy proves to be a useful tool in starting the individual monitoring of sleep in these populations.

Internet Gaming Disorder in Children and Adolescents with Attention Deficit Hyperactivity Disorder.

Although Attention Deficit Hyperactivity Disorder (ADHD) has been related to an increased risk for behavioral addictions, the relationship between ADHD and Internet Gaming Disorder (IGD) is still debated. The aim of this study is to address this topic by exploring the prevalence of IGD in a consecutive sample of ADHD youth, compared to a normal control group, and by assessing selected psychopathological and cognitive features in ADHD patients with and without IGD. One hundred and eight patients with ADHD (mean age 11.7 ± 2.6 years, 96 males) and 147 normal controls (NC) (mean age 13.9 ± 3.0 years, 114 males) were included in the study and received structured measures for IGD. In the ADHD group, 44% of the sample were above the IGD cut-off, compared to 9.5% in the NC group. ADHD patients with IGD presented with greater severity and impairment, more severe ADHD symptomatology, more internalizing symptoms, particularly withdrawal/depression and socialization problems, and more prominence of addiction and evasion dimensions. A binary logistic regression showed that the degree of inattention presented a greater weight in determining IGD. These findings may be helpful for identifying, among ADHD patients, those at higher risk for developing a superimposed IGD.

Parenting practices moderate the link between attention to the eyes and callous unemotional traits in children with Disruptive Behavior Disorder: An eye-tracking study.

Callous-unemotional (CU) traits are associated with gaze pattern deficits in youths, though it has not yet been explored if environmental factors could influence this relationship. Since parenting can influence both CU traits and children's emotion processing, the current study sought to test whether parenting moderated the relation between gaze pattern deficits and CU traits in a sample of children with Disruptive Behavior Disorder. The sample included 92 boys (aged 7-12 years) with Conduct Disorder (N = 12) and Oppositional Defiant Disorder (N = 80). All children completed a task, during which they were presented with 24 images depicting happy, sad, fearful, disgusted, angry, and neutral facial expressions. Gaze pattern has been recorded throughout the task with an eye-tracker. Positive parenting moderated the association between CU traits and first fixation duration to the eyes of facial expressions depicting negative emotions. Negative parenting moderated the association between CU traits and fixation count and fixation duration to the eyes of negative emotions. Negative parenting along with reduced attention to emotional cues (i.e., eyes) may identify a group of youths with Disruptive Behavior Disorder diagnosis at risk for severe outcomes.

Measures of empathy in children and adolescents: A systematic review of questionnaires.

BACKGROUND: Empathy has long been considered a multidimensional construct, encompassing cognitive, affective and behavioral domains. Deficits in empathic competences in early childhood contribute to psychopathology, and have been variably implicated in several clinical conditions, such as autism spectrum disorders (ASD) and conduct disorders. AIM: To identify and describe empirically validated questionnaires assessing empathy in children and adolescents and to provide a summary of related theoretical perspectives on empathy definitional issues. METHODS: A systematic review of the literature was conducted. Three bibliographic databases were searched. A total of 47 studies were selected for final analysis and 16 distinct measures were identified and described. RESULTS: Questionable to excellent levels of internal consistency were observed, while few studies assessed test-retest reliability. Although construct definitions only partially overlapped, affective and cognitive domains of empathy were the commonest internal factors that were often separately evaluated. New facets of the construct (i.e., somatic empathy and sympathy) and specific clinical populations (i.e., ASD) could be specifically addressed through more recent instruments. CONCLUSION: The combination of different assessment methods is recommended in order to foresee further improvements in this field and try to overcome the problem of limited convergence with more objective measures.

Parenting and Sibling Relationships in Family with Disruptive Behavior Disorders. Are Non-Clinical Siblings More Vulnerable for Emotional and Behavioral Problems?

Disruptive Behavior Disorders (DBD) are the most common mental health disorders in the school-aged child population. Although harsh parenting is a key risk factor in the shaping of DBD, studies neglect the presence of siblings and differential parenting. This study aims to compare: (1) parenting style and sibling relationship in sibling dyads of clinical families, composed of a DBD child and a non-clinical sibling, with control families composed of two non-clinical siblings; (2) parenting style, sibling relationship, and emotional and behavioral problems in DBD child, non-clinical sibling, and non-clinical child of control group. Sixty-one families (composed of mother and sibling dyads), divided into clinical (n = 27) and control (n = 34) groups, completed the APQ, SRI, and CBCL questionnaires. Results indicated differential parenting in clinical families, compared to control group families, with higher negative parenting toward the DBD child than the sibling; no difference emerged in sibling relationship within sibling dyads (clinical vs. control). Finally, externalizing and internalizing problems were higher in DBD children and their siblings, compared to control, indicating DBD sibling psychopathology vulnerability. Findings suggest inclusion of siblings in the clinical assessment and rehabilitative intervention of DBD children, given that the promotion of positive parenting could improve mental health in the offspring.

Autism Spectrum Disorder and Disruptive Behavior Disorders Comorbidities Delineate Clinical Phenotypes in Attention-Deficit Hyperactivity Disorder: Novel Insights from the Assessment of Psychopathological and Neuropsychological Profiles.

Although childhood-onset psychiatric disorders are often considered as distinct and separate from each other, they frequently co-occur, with partial overlapping symptomatology. Autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) commonly co-occur with each other and with other mental disorders, particularly disruptive behavior disorders, oppositional defiant disorder/conduct disorder (ODD/CD). Whether these associated comorbidities represent a spectrum of distinct clinical phenotypes is matter of research. The aim of our study was to describe the clinical phenotypes of youths with ADHD with and without ASD and/or ODD/CD, based on neuropsychological and psychopathological variables. One-hundred fifty-one participants with ADHD were prospectively recruited and assigned to four clinical groups, and assessed by means of parent-reported questionnaires, the child behavior checklist and the behavior rating inventory of executive functions. The ADHD alone group presented a greater impairment in metacognitive executive functions, ADHD+ASD patients presented higher internalizing problems and deficits in Shifting tasks, and ADHD+ODD/CD subjects presented emotional-behavioral dysregulation. Moreover, ADHD+ASD+ODD/CD individuals exhibited greater internalizing and externalizing problems, and specific neuropsychological impairments in the domains of emotional regulation. Our study supports the need to implement the evaluation of the psychopathological and neuropsychological functioning profiles, and to characterize specific endophenotypes for a finely customized establishment of treatment strategies.

A Naturalistic Study of Youth Referred to a Tertiary Care Facility for Acute Hypomanic or Manic Episode.

BACKGROUND: Bipolar Disorders (BD) in youth are a heterogeneous condition with different phenomenology, patterns of comorbidity and outcomes. Our aim was to explore the effects of gender; age at onset (prepubertal- vs. adolescent-onset) of BD; and elements associated with attention deficit hyperactivity disorder (ADHD) and Substance Use Disorder (SUD) comorbidities, severe suicidal ideation or attempts, and poorer response to pharmacological treatments. METHOD: 117 youth (69 males and 57 females, age range 7 to 18 years, mean age 14.5 ± 2.6 years) consecutively referred for (hypo)manic episodes according to the Diagnostic and Statistical Manual of Mental Disorders, 54th ed (DSM 5) were included. RESULTS: Gender differences were not evident for any of the selected features. Prepubertal-onset BD was associated with higher rates of ADHD and externalizing disorders. SUD was higher in adolescent-onset BD and was associated with externalizing comorbidities and lower response to treatments. None of the selected measures differentiated patients with or without suicidality. At a 6-month follow up, 51.3% of the patients were responders to treatments, without difference between those receiving and not receiving a psychotherapy. Clinical severity at baseline and comorbidity with Conduct Disorder (CD) and SUD were associated with poorer response. Logistic regression indicated that baseline severity and number of externalizing disorders were associated with a poorer outcome. CONCLUSIONS: Disentangling broader clinical conditions in more specific phenotypes can help timely and focused preventative and therapeutic interventions.

The Role of Executive Functions in the Development of Empathy and Its Association with Externalizing Behaviors in Children with Neurodevelopmental Disorders and Other Psychiatric Comorbidities.

Executive functions have been previously shown to correlate with empathic attitudes and prosocial behaviors. People with higher levels of executive functions, as a whole, may better regulate their emotions and reduce perceived distress during the empathetic processes. Our goal was to explore the relationship between empathy and executive functioning in a sample of children and adolescents diagnosed with Attention Deficit and Hyperactivity Disorder alone or associated with comorbid Disruptive Behavior Disorders and/or Autism Spectrum Disorder. We also aimed to examine the role of empathic dimensions and executive skills in regulating externalizing behaviors. The 151 participants with ADHD were assigned to four groups according to their psychiatric comorbidity (either "pure" or with ASD and/or ODD/CD) and assessed by means of either parent- or self-reported questionnaires, namely the BRIEF-2, the BES, and the IRI. No questionnaire was found to discriminate between the four groups. Affective Empathy was found to positively correlate with Emotional and Behavioral Regulation competences. Furthermore, Aggressiveness and Oppositional Defiant Problems were positively associated with Executive Emotional and Behavioral Regulation competences. On the other hand, Rule-Breaking Behaviors and Conduct Problems were negatively associated with Affective Empathy and with Behavioral skills. Our study provides an additional contribution for a better understanding of the complex relationship between empathic competence and executive functions, showing that executive functioning and empathic attitudes interact with each other to regulate aggressive behaviors. This study further corroborates developmental models of empathy and their clinical implications, for which externalizing behaviors could be attenuated by enhancing executive functioning skills.

EYES Are The Window to the Mind: Eye-Tracking Technology as a Novel Approach to Study Clinical Characteristics of ADHD.

In recent years, the study of eye movements has increasingly become a window into neurological function and processes. This paper reports data about applications of eye-tracking technology in the field of neurodevelopmental disorders, especially in studying the clinical characteristics of ADHD. These studies indicated that eye-tracking approach represents a non-invasive methodology to test specific domains, such as attention networks and inhibition control, in an objectively and reliable way in youths. Although the studies results are still not conclusive, eye-tracking represents a potential valid support for clinicians in identifying specific biomarkers to orient ADHD diagnosis and the best intervention strategies.

[Origins and evaluation of youth narcissism]. / Eziopatogenesi e valutazione dei tratti narcisistici in età evolutiva.

Recently, studies have focused on narcissism as a personality trait, which can be detected during childhood, and can lead to negative outcomes, such as emotional and behavioral problems. After illustrating the main hypotheses on the development of narcissistic traits in children, this paper aims to outline the relation between narcissism, self-esteem and emotional, and behavioral problems in children. Finally, are presented measures for the assessment of narcissistic traits in children and adolescents.

Empathy in Youths with Conduct Disorder and Callous-Unemotional Traits.

Previous studies indicated that a lack of empathy could be considered the core feature of callous-unemotional (CU) traits in children and adolescents. The present study is aimed at exploring relationships among CU traits, cognitive and emotional dimensions of empathy, emotion recognition (basic, social, and complex emotions), and history of maltreatment in a sample of youths with conduct disorder diagnosis. The sample consisted of 60 Italian male patients (age range 11-17 years, mean age 13.27 ± 1.90 years) referred to the Department of Child and Adolescent Psychiatry (Pisa, Italy). In the whole sample, the levels of CU traits were significantly negatively associated with both cognitive and emotional dimensions of empathy; in addition, the CD patients with high levels of CU traits show significantly lower levels of empathic concern compared to those with low levels of CU traits. Clinical implications of the findings are discussed.

Effects of melatonin in children with attention-deficit/hyperactivity disorder with sleep disorders after methylphenidate treatment.

PURPOSE: Methylphenidate (MPH), the first-line medication in children with attention-deficit/hyperactivity disorder (ADHD), is associated with increased risk of sleep disorders. Melatonin has both hypnotic and chronobiotic properties that influence circadian rhythm sleep disorders. This study explores the effectiveness of melatonin in children with ADHD who developed sleep problems after starting MPH. PATIENTS AND METHODS: This study, based on a clinical database, included 74 children (69 males, mean age 11.6±2.2 years) naturalistically treated with MPH (mean dosage 33.5±13.5 mg/d). The severity of sleep disorder (sleep onset delay) was recorded at baseline and after a follow-up of at least 4 weeks using a seven-point Likert scale according to the Clinical Global Impression Severity score. Effectiveness of melatonin on sleep (mean dosage 1.85±0.84 mg/d) after 4 weeks was assessed using a seven-point Likert scale according to the Clinical Global Impression Improvement (CGI-I) score, and patients who scored 1 (very much improved) or 2 (much improved) were considered responders. RESULTS: Clinical severity of sleep disorders was 3.41±0.70 at the baseline and 2.13±1.05 after the follow-up (P<0.001). According to the CGI-I score, 45 patients (60.8%) responded to the treatment with melatonin. Gender and age (children younger and older than 12 years) did not affect the response to melatonin on sleep. Patients with or without comorbidities did not differ according to sleep response. Specific comorbidities with disruptive behavior disorders (oppositional defiant disorder or conduct disorder), affective (mood and anxiety) disorders and learning disabilities did not affect the efficacy of melatonin on sleep. Treatment was well tolerated, and no side effects related to melatonin were reported. CONCLUSION: In children with ADHD with sleep problems after receiving MPH treatment, melatonin may be an effective and safe treatment, irrespective of gender, age and comorbidities.

Transcranial Direct Current Stimulation (tDCS) in Unilateral Cerebral Palsy: A Pilot Study of Motor Effect.

Transcranial Direct Current Stimulation (tDCS) is an emerging tool to improve upper limb motor functions after stroke acquired in adulthood; however, there is a paucity of reports on its efficacy for upper limb motor rehabilitation in congenital or early-acquired stroke. In this pilot study we have explored, for the first time, the immediate effects, and their short-term persistence, of a single application of anodal tDCS on chronic upper limb motor disorders in children and young individuals with Unilateral Cerebral Palsy (UCP). To this aim, in a crossover sham-controlled study, eight subjects aged 10-28 years with UCP underwent two sessions of active and sham tDCS. Anodal tDCS (1.5 mA, 20 min) was delivered over the primary motor cortex (M1) of the ipsilesional hemisphere. Results showed, only following the active stimulation, an immediate improvement in unimanual gross motor dexterity of hemiplegic, but not of nonhemiplegic, hand in Box and Block test (BBT). Such improvement remained stable for at least 90 minutes. Performance of both hands in Hand Grip Strength test was not modified by anodal tDCS. Improvement in BBT was unrelated to participants' age or lesion size, as revealed by MRI data analysis. No serious adverse effects occurred after tDCS; some mild and transient side effects (e.g., headache, tingling, and itchiness) were reported in a limited number of cases. This study provides an innovative contribution to scientific literature on the efficacy and safety of anodal tDCS in UCP. This trial is registered with NCT03137940.

Effects on Parental Stress of Early Home-Based CareToy Intervention in Low-Risk Preterm Infants.

Parenting a preterm infant is more challenging than a full-term one. Parent involvement in early intervention programs seems to have positive psychosocial effects on both the child and parent. CareToy is an innovative smart system that provides an intensive individualized home-based family-centred EI in preterm infants between 3 and 9 age-corrected months. A RCT study, preceded by a pilot study, has been recently carried out to evaluate the effects of CareToy intervention on neurodevelopmental outcomes with respect to Standard Care. This study aims at evaluating the effects of CareToy early intervention on parenting stress in preterm infants. Parents (mother and father) of a subgroup of infants enrolled in the RCT filled out a self-report questionnaire on parenting stress (Parenting Stress Index-Short Form (PSI-SF)) before (T0) and after (T1) the CareToy or Standard Care period (4 weeks), according to the allocation of their preterm infant. For twins, an individual questionnaire for each one was filled out. Results obtained from mothers and fathers were separately analysed with nonparametric tests. 44 mothers and 44 fathers of 44 infants (24 CareToy/20 Standard Care) filled out the PSI-SF at T0 and at T1. CareToy intervention was mainly managed by mothers. A significant (p < 0.05) reduction in Parental Distress subscale in the CareToy group versus Standard Care was found in the mothers. No differences were found among the fathers. CareToy training seems to be effective in reducing parental distress in mothers, who spent more time on CareToy intervention. These findings confirm the importance of parental involvement in early intervention programs. This trial is registered with Clinical Trial.gov NCT01990183.

Improving Executive Functions at School in Children With Special Needs by Educational Robotics.

Children with Special Needs represent a highly heterogeneous group in terms of neurofunctional, behavioral, and socio-cognitive characteristics, but they have in common a frequent impairment of Executive Functions. Educational Robotics is generally dedicated to study the effects of constructing and programming robots based on children's learning and academic achievement. Recently, we found that being engaged in progressively more challenging robot planning and monitoring (ER-Lab) promotes visual-spatial working memory and response inhibition in early childhood during typical development, and that an ER-Lab can be a feasible rehabilitative tool for children with Special Needs. The present study aimed to verify the efficacy of the ER-Lab on Executive Functions in children with Special Needs for the first time by using an RCT within their school environment. To pursue these aims, this study reports the results obtained in 42 first-grade children with Special Needs engaged in school Educational Robotics Laboratories (ER-Lab) to promote Executive Functions by means of enjoyable, intensive, and incrementally more challenging activities requiring them to program a bee-shaped robot called Bee-bot® (Campus Store). Several adaptations were done to meet different motor, cognitive, and social needs. All children were evaluated by means of standardized tests performed by each child before and at the end of the ER-Lab activities. Children with Special Needs had significantly improved inhibition skills, and children with attentional impairment had more benefits in their inhibition of motor responses tasks with respect to children with a language deficit. Results of the study and future perspectives on how ER-Lab programs could become a powerful tool in classrooms with children with special needs are discussed.

Empowering Executive Functions in 5- and 6-Year-Old Typically Developing Children Through Educational Robotics: An RCT Study.

Educational Robotics (ER) is a new learning approach that is known mainly for its effects on scientific academic subjects such as science, technology, engineering, and mathematics. Recent studies indicate that ER can also affect cognitive development by improving critical reasoning and planning skills. This study aimed to quantify the ability of ER to empower Executive Functions (EF), including the ability to control, update, and program information, in 5- and 6-year-old children attending first grade, a crucial evolutionary window for the development of such abilities. A total of 187 typically developing children were enrolled and randomly allocated into two experimental conditions: A, for immediate ER training, and B, for waitlist. ER-Laboratories (ER-Lab) for small groups were organized at schools, using a child-friendly, bee-shaped robot called Bee-Bot® (Campus Store). Activities were intensive, enjoyable, and progressively more challenging over the 20 twice-weekly sessions. Outcome measures, based on standardized tests, were used to quantify the effects of ER on EF. Compared to the control group, the ER-Lab group showed significantly better ability to actively manipulate information in short-term memory and suppress automatic responses in favor of goal-appropriate actions. This RCT study provides the first quantitative evidence of the positive effects of ER activities for improving working memory and inhibition in the early school years.

Assessment of upper limb use in children with typical development and neurodevelopmental disorders by inertial sensors: a systematic review.

Understanding development of bimanual upper limb (UL) activities in both typical and atypical conditions in children is important for: i) tailoring rehabilitation programs, ii) monitoring progress, iii) determining outcomes and iv) evaluating effectiveness of treatment/rehabilitation. Recent technological advances, such as wearable sensors, offer possibilities to perform standard medical monitoring. Body-worn motion sensors, mainly accelerometers, have shown very promising results but, so far, these studies have mainly focused on adults. The main aim of this review was to report the evidence of UL activity of both typically developing (TD) children and children with neurodevelopmental disorders (NDDs) that are reliably reported and comparable, using a combination of multiple wearable inertial sensors, both in laboratory and natural settings. Articles were selected from three research databases (PubMed, Web of Science and EBSCO). Included studies reported data on children aged 0-20 years old simultaneously wearing at least two inertial sensors on upper extremities. The collected and reported data were relevant in order to describe the amount of physical activity performed by the two ULs separately. A total of 21 articles were selected: 11 including TD, and 10 regarding NDDs. For each article, a review of both clinical and technical data was performed. We considered inertial sensors used for following aims: (i) to establish activity intensity cut-points; (ii) to investigate validity and reliability of specified markers, placement and/or number of inertial sensors; (iii) to evaluate duration and intensity of natural UL movements, defined motor tasks and tremor; and (iv) to assess efficacy of certain rehabilitation protocols. Our conclusions were that inertial sensors are able to detect differences in use between both hands and that all reviewed studies support use of accelerometers as an objective outcome measure, appropriate in assessing UL activity in young children with NDDs and determining intervention effectiveness. Further research on responsiveness to interventions and consistency with use in real-world settings is needed. This information could be useful in planning UL rehabilitation strategies.

Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy.

INTRODUCTION: A new rehabilitative approach, called UPper Limb Children Action Observation Training (UPCAT), based on the principles of action observation training (AOT), has provided promising results for upper limb rehabilitation in children with unilateral cerebral palsy (UCP). This study will investigate if a new information and communication technology platform, named Tele-UPCAT, is able to deliver AOT in a home setting and will test its efficacy on children and young people with UCP. METHODS AND ANALYSIS: A randomised, allocation concealed (waitlist control) and evaluator-blinded clinical trial with two investigative arms will be carried out. The experimental group will perform AOT at home for 3 weeks using a customised Tele-UPCAT system where they will watch video sequences of goal-directed actions and then complete the motor training of the same actions. The control group will receive usual care for 3 weeks, which may include upper limb training. They will be offered AOT at home after 3 weeks. Twenty-four children with UCP will be recruited for 12 participants per group. The primary outcome will be measured using Assisting Hand Assessment. The Melbourne Assessment 2, ABILHAND, Participation and Environment Measure-Children and Youth and Cerebral Palsy Quality of Life Questionnaire will be included as secondary measures. Quantitative measures from sensorised objects and participants worn Actigraphs GXT3+ will be analysed. The assessment points will be the week before (T0) and after (T1) the period of AOT/standard care. Further assessments will be at T1 plus, the week after the AOT period for the waitlist group and at 8 weeks (T2) and 24 weeks (T3) after AOT training. ETHICS AND DISSEMINATION: The trial has been approved by the Tuscany Paediatric Ethics Committee (169/2016). Publication of all outcomes will be in peer-reviewed journals and conference presentations. TRIAL REGISTRATION: NCT03094455.

A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'.

CareToy system is an innovative tele-rehabilitative tool, useful in providing intensive, individualized, home-based, family-centred Early Intervention (EI) in infants. Our aim was to evaluate, through a Randomized Clinical Trial (RCT) study, the effects of CareToy intervention on early motor and visual development in preterm infants. 41 preterm infants (range age: 3.0-5.9 months of corrected age) were enrolled and randomized into two groups, CareToy and Standard Care. 19 infants randomized in CareToy group performed a 4-week CareToy program, while 22 allocated to control group completed 4 weeks of Standard Care. Infant Motor Profile (IMP) was primary outcome measure, Alberta Infant Motor Scale (AIMS) and Teller Acuity Cards were secondary ones. Assessments were carried out at baseline (T0) and at the end of CareToy training or Standard Care period (T1). T1 was the primary endpoint. After RCT phase, 17 infants from control group carried out a 4-week CareToy program, while 18 infants from the CareToy group continued with Standard Care. At the end of this phase, infants were re-assessed at T2. In RCT phase, delta IMP total score and variation and performance sub-domains were significantly higher (P<0.050) in CareToy group if compared to Standard Care group. Similar results were found for Teller Acuity Cards, while no differences between groups were found for AIMS. No differences were found in any outcome measure results (T2-T0), between infants who started CareToy training before or after one month of standard care. This RCT study confirms the results of a previous pilot study, indicating that CareToy system can provide effective home-based EI. TRIAL REGISTRATION: This trial has been registered at www.clinicaltrials.gov (Identifier NCT01990183).