Donatella Valente

Controlled‐release melatonin, singly and combined with cognitive behavioural therapy, for persistent insomnia in children with autism spectrum disorders: a randomized placebo‐controlled trial

Although melatonin and cognitive–behavioural therapy have shown efficacy in treating sleep disorders in children with autism spectrum disorders, little is known about their relative or combined efficacy. One hundred and sixty children with autism spectrum disorders, aged 4–10 years, suffering from sleep onset insomnia and impaired sleep maintenance, were assigned randomly to either (1) combination of controlled‐release melatonin and cognitive–behavioural therapy; (2) controlled‐release melatonin; (3) four sessions of cognitive–behavioural therapy; or (4) placebo drug treatment condition for 12 weeks in a 1 : 1 : 1 : 1 ratio. Children were studied at baseline and after 12 weeks of treatment. Treatment response was assessed with 1‐week actigraphic monitoring, sleep diary and sleep questionnaire. Main outcome measures, derived actigraphically, were sleep latency, total sleep time, wake after sleep onset and number of awakenings. The active treatment groups all resulted in improvements across all outcome measures, with moderate‐to‐large effect sizes from baseline to a 12‐week assessment. Melatonin treatment was mainly effective in reducing insomnia symptoms, while cognitive–behavioural therapy had a light positive impact mainly on sleep latency, suggesting that some behavioural aspects might play a role in determining initial insomnia. The combination treatment group showed a trend to outperform other active treatment groups, with fewer dropouts and a greater proportion of treatment responders achieving clinically significant changes (63.38% normative sleep efficiency criterion of >85% and 84.62%, sleep onset latency <30 min). This study demonstrates that adding behavioural intervention to melatonin treatment seems to result in a better treatment response, at least in the short term.

Vineland Adaptive Behavior Profiles in Children with Autism and Moderate to Severe Developmental Delay

The purpose of this study was to examine adaptive behaviour profiles in children with autism and moderate to severe developmental delay. Previous research has found that children with autism present a characteristic pattern of adaptive behaviour, as measured by the Vineland Adaptive Behavior Scales (VABS) (deficit in the domain of socialization, relative deficit in the domain of communication and relative strength in the domain of daily living). In this study VABS were administered (as part of a comprehensive evaluation of abilities) to a sample of 50 children with moderate to severe developmental delay (23 children with autism and 27 chronological and developmental age matched non-autistic children). Contrary to initial predictions, the sample presented fairly homogeneous adaptive behaviour profiles. Results are discussed with respect to the effectiveness of adaptive behaviour profiles in the detection of autism and the importance of employing limited chronological and developmental age ranges in the study of autism in infancy.

Sleep in children with autism with and without autistic regression

The purpose of the present investigation was to characterize and compare traditional sleep architecture and non‐rapid eye movement (NREM) sleep microstructure in a well‐defined cohort of children with regressive and non‐regressive autism, and in typically developing children (TD). We hypothesized that children with regressive autism would demonstrate a greater degree of sleep disruption either at a macrostructural or microstructural level and a more problematic sleep as reported by parents. Twenty‐two children with non‐regressive autism, 18 with regressive autism without comorbid pathologies and 12 with TD, aged 5–10 years, underwent standard overnight multi‐channel polysomnographic evaluation. Parents completed a structured questionnaire (Childrens’ Sleep Habits Questionnaire—CSHQ). The initial hypothesis, that regressed children have more disrupted sleep, was supported by our findings that they scored significantly higher on CSHQ, particularly on bedtime resistance, sleep onset delay, sleep duration and night wakings CSHQ subdomains than non‐regressed peers, and both scored more than typically developing controls. Regressive subjects had significantly less efficient sleep, less total sleep time, prolonged sleep latency, prolonged REM latency and more time awake after sleep onset than non‐regressive children and the TD group. Regressive children showed lower cyclic alternating pattern (CAP) rates and A1 index in light sleep than non‐regressive and TD children. Our findings suggest that, even though no particular differences in sleep architecture were found between the two groups of children with autism, those who experienced regression showed more sleep disorders and a disruption of sleep either from a macro‐ or from a microstructural viewpoint.

Slow EEG Amplitude Oscillations During NREM Sleep and Reading Disabilities in Children With Dyslexia

Study Objectives: To analyze non-rapid eye movement (NREM) sleep microstructure of children with dyslexia, by means of cyclic alternating pattern (CAP) analysis and to correlate CAP parameters with neuropsychological measures. Design: Cross-sectional study using polysomnographic recordings and neuropsychological assessments. Setting: Sleep laboratory in academic center. Participants: Sixteen subjects with developmental dyslexia (mean age 10.8 years) and 11 normally reading children (mean age 10.1 years) underwent overnight polysomnographic recording. Intervention: N/A. Measurements and Results: Sleep architecture parameters only showed some statistically significant differences: number of sleep stage shifts per hour of sleep, percentage of N3, and number of R periods were significantly lower in dyslexic children versus controls. CAP analysis revealed a higher total CAP rate and A1 index in stage N3. A2% and A2 index in stage N2 and N3 were lower in dyslexic children while no differences were found for A3 CAP subtypes. The correlation analysis between CAP parameters and cognitive-behavioral measures showed a significant positive correlation between A1 index in N3 with Verbal IQ, full-scale IQ, and Memory and Learning Transfer reading test; while CAP rate in N3 was positively correlated with verbal IQ. Conclusions: To overcome reading difficulties, dyslexic subjects overactivate thalamocortical and hippocampal circuitry to transfer information between cortical posterior and anterior areas. The overactivation of the ancillary frontal areas could account for the CAP rate modifications and mainly for the increase of CAP rate and of A1 index in N3 that seem to be correlated with IQ and reading abilities.

Cross-cultural adaptation and validation of the “Spinal Cord Injury-Falls Concern Scale” in the Italian population

Study designPsychometrics study.ObjectiveThe objective of this study was to develop an Italian version of the Spinal Cord Injury-Falls Concern Scale (SCI-FCS) and examine its reliability and validity.SettingMulticenter study in spinal units in Northern and Southern Italy. The scale also was administered to non-hospitalized outpatient clinic patients.MethodsThe original scale was translated from English to Italian using the “Translation and Cultural Adaptation of Patient-Reported Outcomes Measures” guidelines. The reliability and validity of the culturally adapted scale were assessed following the “Consensus-Based Standards for the Selection of Health Status Measurement Instruments” checklist. The SCI-FCS-I internal consistency, inter-rater, and intra-rater reliability were examined using Cronbach’s alpha coefficient and the intraclass correlation coefficient, respectively. Concurrent validity was evaluated using Pearson’s correlation coefficient with the Italian version of the short form of the Wheelchair Use Confidence Scale for Manual Wheelchair Users (WheelCon-M-I-short form).ResultsThe Italian version of the SCI-FCS-I was administered to 124 participants from 1 June to 30 September 2017. The mean ± SD of the SCI-FCS-I score was 16.73 ± 5.88. All SCI-FCS items were either identical or similar in meaning to the original version’s items. Cronbach’s α was 0.827 (p < 0.01), the inter-rater reliability was 0.972 (p < 0.01), and the intra-rater reliability was 0.973 (p < 0.01). Pearson’s correlation coefficient of the SCI-FCS-I scores with the WheelCon-M-I-short form was 0.56 (p < 0.01).ConclusionsThe SCI-FCS-I was found to be reliable and a valid outcome measure for assessing manual wheelchair concerns about falling in the Italian population.

A Psychometric Properties Evaluation of the Italian Version of the Geriatric Depression Scale

Objective The Geriatric Depression Scale (GDS) is an evaluation tool to diagnose older adults depression. This questionnaire was defined by Yesavage and Brink in 1982; it was designed expressly for the older person and defines his/her degree of satisfaction, quality of life, and feelings. The objective of this study is to evaluate the psychometric properties of the Italian translation of the Geriatric Depression Scale (GDS-IT). Methods The Italian version of the Geriatric Depression Scale was administered to 119 people (79 people with a depression diagnosis and 40 healthy ones). We examined the following psychometric characteristics: internal consistency reliability, test-retest reliability, concurrent validity, and construct validity (factor structure). Results Cronbachs Alpha for the GDS-IT administered to the depressed sample was 0.84. Test-retest reliability was 0.91 and the concurrent validity was 0.83. The factorial analysis showed a structure of 5 factors, and the scale cut-off is between 10 and 11. Conclusion The GDS-IT proved to be a reliable and valid questionnaire for the evaluation of depression in an Italian population. In the present study, the GDS-IT showed good psychometric properties. Health professionals now have an assessment tool for the evaluation of depression symptoms in the Italian population.

Reliability and Validity of the Geriatric Depression Scale in Italian Subjects with Parkinson’s Disease

Introduction The Geriatric Depression Scale (GDS) is commonly used to assess depressive symptoms, but its psychometric properties have never been examined in Italian people with Parkinsons disease (PD). The aim of this study was to study the reliability and validity of the Italian version of the GDS in a sample of PD patients. Methods The GDS was administered to 74 patients with PD in order to study its internal consistency, test-retest reliability, construct, and discriminant validity. Results The internal consistency of GDS was excellent (α = 0.903), as well as the test-retest reliability (ICC = 0.941 [95% CI: 0.886–0.970]). GDS showed a strong correlation with instruments related to the depression (ρ = 0.880) in PD (ρ = 0.712) and a weak correlation with generic measurement instruments (−0.320 < ρ <−0.217). An area under the curve of 0.892 (95% CI 0.809–0.975) indicated a moderate capability to discriminate depressed patients to nondepressed patient, with a cutoff value between 15 and 16 points that predicts depression (sensitivity = 87%; specificity = 82%). Conclusion The GDS is a reliable and valid tool in a sample of Italian PD subjects; this scale can be used in clinical and research contexts.

Evaluation of pelvis postural systems in spinal cord injury patients: Outcome research

Objectives Compare three commercially available postural systems to determine the best for treatment of patients suffering from spinal cord injury lesion below the cervical spine. Design Outcome Research. Setting Ambulatory. Participants Thirteen patients were recruited for this study between March 2016 and July 2016 from the Occupational Therapy clinic of “Policlinico Umberto I” hospital in Rome and Occupational Therapy of “CPO” hospital in Ostia. The patient samples consisted of eleven men (84.6%) and two women (15.4%). All the patient are suffering by SCI with a lesion below the cervical spine. Intervention We evaluate postural systems customized by three different companies. Patients tried each pelvis device for a duration of one week, after which they have been asked to fill in questionnaire concerning static stability, temperature, movement adaptability, transfers and dynamical stability during the activities of every-day life. The impact on the health status has been evaluated by means of a further questionnaire (Health Status Scale SF-12) submitted to the patients. Outcome Measures Quality of life and daily life activities. Results The analysis of the data from the questionnaire, along with those of objective nature associated with the mapping of the pressure due to weight distribution, has allowed the selection of the most appropriate clinical solution. Conclusion This study has allowed two significant conclusions: the central role of the interplay between the patient and occupational therapist in the decision role and the clear evidence that patients with spinal cord injury felt definite differences between cushion stability and were able to indicate a specific typology providing the best satisfaction.