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We explored patterns of concomitant psychiatric disorders in a large sample of treatment-seeking children and adolescents with autism spectrum disorder (ASD). Participants were 658 children with ASD (age 3–17 years; mean = 7.2 years) in one of six federally-funded multisite randomized clinical trials (RCT) between 1999 and 2014. All children were referred for hyperactivity or irritability. Study designs varied, but all used the Child and Adolescent Symptom Inventory or Early Childhood Inventory to assess Attention Deficit Hyperactivity Disorder (ADHD), Oppositional-Defiant Disorder (ODD), Conduct Disorder (CD), Anxiety Disorders, and Mood Disorders. In addition, several measures in common were used to assess demographic and clinical characteristics. Of the 658 children, 73% were Caucasian and 59% had an IQ >70. The rates of concomitant disorders across studies were: ADHD 81%, ODD 46%, CD 12%, any anxiety disorder 42%, and any mood disorder 8%. Two or more psychiatric disorders were identified in 66% of the sample. Of those who met criteria for ADHD, 50% also met criteria for ODD and 46% for any anxiety disorder. Associations between types of concomitant disorders and a number of demographic and clinical characteristics are presented. In this well-characterized sample of treatment-seeking children with ASD, rates of concomitant psychiatric disorders were high and the presence of two or more co-occurring disorders was common. Findings highlight the importance of improving diagnostic practice in ASD and understanding possible mechanisms of comorbidity. •We observed a high frequency of multiple concomitant DSM-defined disorders.•50% of children who met criteria for ADHD also met criteria for ODD.•46% of children who met criteria for ADHD also met criteria for an anxiety disorder.•Findings highlight the importance of improving diagnostic practices in ASD.

Intranasal oxytocin therapy has been used to improve various aspects of autism spectrum disorder on the basis of tenuous results from small studies. In a randomized trial involving 290 participants 3 to 17 years of age with autism spectrum disorder, daily use of oxytocin did not improve measures of social interaction as compared with placebo over a period of 24 weeks.

Although small-scale studies have described the effects of oxytocin on social deficits in autism spectrum disorder (ASD), no large-scale study has been conducted. In this randomized, parallel-group, multicenter, placebo-controlled, double-blind trial in Japan, 106 ASD individuals (18–48 y.o.) were enrolled between Jan 2015 and March 2016. Participants were randomly assigned to a 6-week intranasal oxytocin (48IU/day, n = 53) or placebo (n = 53) group. One-hundred-three participants were analyzed. Since oxytocin reduced the primary endpoint, Autism Diagnostic Observation Schedule (ADOS) reciprocity, (from 8.5 to 7.7; P < .001) but placebo also reduced the score (8.3 to 7.2; P < .001), no between-group difference was found (effect size −0.08; 95% CI, −0.46 to 0.31; P = .69); however, plasma oxytocin was only elevated from baseline to endpoint in the oxytocin-group compared with the placebo-group (effect size −1.12; −1.53 to −0.70; P < .0001). Among the secondary endpoints, oxytocin reduced ADOS repetitive behavior (2.0 to 1.5; P < .0001) compared with placebo (2.0 to 1.8; P = .43) (effect size 0.44; 0.05 to 0.83; P = .026). In addition, the duration of gaze fixation on socially relevant regions, another secondary endpoint, was increased by oxytocin (41.2 to 52.3; P = .03) compared with placebo (45.7 to 40.4; P = .25) (effect size 0.55; 0.10 to 1.0; P = .018). No significant effects were observed for the other secondary endpoints. No significant difference in the prevalence of adverse events was observed between groups, although one participant experienced temporary gynecomastia during oxytocin administration. Based on the present findings, we cannot recommend continuous intranasal oxytocin treatment alone at the current dose and duration for treatment of the core social symptoms of high-functioning ASD in adult men, although this large-scale trial suggests oxytocin’s possibility to treat ASD repetitive behavior.

This pilot RCT compared the effect of a self-directed and therapist-assisted telehealth-based parent-mediated intervention for young children with ASD. Families were randomly assigned to a self-directed or therapist-assisted program. Parents in both groups improved their intervention fidelity, self-efficacy, stress, and positive perceptions of their child; however, the therapist-assisted group had greater gains in parent fidelity and positive perceptions of child. Children in both groups improved on language measures, with a trend towards greater gains during a parent–child interaction for the therapist-assisted group. Only the children in the therapist-assisted group improved in social skills. Both models show promise for delivering parent-mediated intervention; however, therapist assistance provided an added benefit for some outcomes. A full-scale comparative efficacy trial is warranted.

Research suggests that impaired social skills are often the most significant challenge for those with autism spectrum disorder (ASD), yet few evidence-based social skills interventions exist for adults on the spectrum. This replication trial tested the effectiveness of PEERS, a caregiver-assisted social skills program for high-functioning young adults with ASD. Using a randomized controlled design, 22 young adults 18–24 years of age were randomly assigned to a treatment ( n  = 12) or delayed treatment control ( n  = 10) group. Results revealed that the treatment group improved significantly in overall social skills, frequency of social engagement, and social skills knowledge, and significantly reduced ASD symptoms related to social responsiveness following PEERS. Most treatment gains were maintained at a 16-week follow-up assessment with new improvements observed.

Autism spectrum disorder (ASD) is a rapidly growing neurodevelopmental disorder. Both probiotics and oxytocin were reported to have therapeutic potential; however, the combination therapy has not yet been studied. We conducted a randomized, double-blinded, placebo-controlled, 2-stage pilot trial in 35 individuals with ASD aged 3–20 years (median = 10.30 years). Subjects were randomly assigned to receive daily Lactobacillus plantarum PS128 probiotic (6 × 1010 CFUs) or a placebo for 28 weeks; starting on week 16, both groups received oxytocin. The primary outcomes measure socio-behavioral severity using the Social Responsiveness Scale (SRS) and Aberrant Behavior Checklist (ABC). The secondary outcomes include measures of the Clinical Global Impression (CGI) scale, fecal microbiome, blood serum inflammatory markers, and oxytocin. All outcomes were compared between the two groups at baseline, 16 weeks, and 28 weeks into treatment. We observed improvements in ABC and SRS scores and significant improvements in CGI-improvement between those receiving probiotics and oxytocin combination therapy compared to those receiving placebo (p < 0.05). A significant number of favorable gut microbiome network hubs were also identified after combination therapy (p < 0.05). The favorable social cognition response of the combination regimen is highly correlated with the abundance of the Eubacterium hallii group. Our findings suggest synergic effects between probiotics PS128 and oxytocin in ASD patients, although further investigation is warranted.

Children with Autism Spectrum Disorder (ASD) often experience deficits in motor coordination, sensory processing, and social interaction, which hinder their participation in physical activities. While sensory integration-based interventions have shown promise, the specific impact of structured sports training incorporating sensory principles remains underexplored. This study evaluated the effects of a 12-week sensory integration-based sports training program on motor and social outcomes in children with ASD. Forty participants, aged 6–12, were randomly assigned to either an experimental group receiving sensory integration-based sports training or a control group engaged in standard physical activity. Motor coordination was assessed using the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), and social responsiveness was measured using the Social Responsiveness Scale (SRS-2). Weekly behavioral engagement was also recorded. Data were analyzed using paired t-tests and Cohen’s d for effect size. Participants in the intervention group demonstrated a significant 17.2-point increase in BOT-2 scores, reflecting improved motor coordination. SRS-2 scores decreased by 13.2 points, indicating enhanced social responsiveness. Participation rates in structured activities increased from 45 to 85% over the 12 weeks. Statistical analysis revealed a large effect size (Cohen’s d > 0.8) for both outcomes. Sensory integration-based sports training significantly improves motor and social functioning in children with ASD and offers a promising approach for therapeutic and educational rehabilitation programs.

Evidence-based robotic intervention programmes for children with autism spectrum disorder (ASD) have been limited. As yet, there is insufficient evidence to inform therapists, teachers, and service providers on effectiveness of robotic intervention to enhance social development and participation of children with ASD in a real context. This study used a randomised controlled trial to test the efficacy of robotic intervention programmes in enhancing the social development and participation of children with ASD. 60 children with ASD were included. The participants were randomly assigned to the following groups: (1) robotic intervention programme ( n  = 20), (2) human-instructed programme ( n  = 20), and (3) control group ( n  = 20). Both the performance-based behavioural change in social communication and parent-reported change in social responsiveness were evaluated. The participants in the robotic intervention group demonstrated statistically significant changes in both the performance-based assessment and parent-reported change in social participation. Significant differences were found in the communication and reciprocal social interactions scores between the experimental group and the control and comparison groups in the performance-based assessment ( p  < 0.01). The effectiveness of robotic intervention programme to enhance the social communication and participation was confirmed. Future studies may also consider adding a maintenance phase to document how the effects of the intervention carry over to the participants over a longer period. (Clinical trial number: NCT04879303; Date of registration: 10 May 2021).

Several lines of emerging data point to an imbalance between neuronal excitation and inhibition in at least a subgroup of individuals with autism spectrum disorder (ASD), including in those with fragile X syndrome (FXS), one of the most common genetic syndromes within ASD. In animal models of FXS and of ASD, GABA-B agonists have improved both brain and behavioral phenotypes, including social behavior. A phase 2 randomized, placebo-controlled, crossover trial found that the GABA-B agonist arbaclofen improved social avoidance symptoms in FXS. A pilot open-label trial of arbaclofen suggested similar benefits in ASD. We therefore evaluated arbaclofen in a randomized, placebo-controlled, phase 2 study of 150 participants, aged 5-21 years, with ASD. No difference from placebo was detected on the primary outcome measure, the parent-rated Aberrant Behavior Checklist Social Withdrawal/Lethargy subscale. However, a specified secondary analysis found improvement on the clinician-rated Clinical Global Impression of Severity. An exploratory post hoc analysis of participants with a consistent rater across the trial revealed greater improvement in the Vineland Adaptive Behavior Scales II socialization domain in participants receiving arbaclofen. Affect lability (11%) and sedation (9%) were the most common adverse events. In this exploratory study, secondary analyses suggest that arbaclofen may have the potential to improve symptoms in some children with ASD, but further study will be needed to replicate and extend these initial findings.

Many children with autism spectrum disorder (ASD) have problem behaviors that interfere with learning and social interaction. This randomized controlled trial compared treatment with functional communication training (FCT) to “treatment as usual” for young children with ASD (n = 38, ages 21–84 months). FCT was conducted by parents with training and real-time coaching provided by behavioral consultants using telehealth. FCT treatment via telehealth achieved a mean reduction in problem behavior of 98% compared to limited behavioral improvement in children receiving “treatment as usual” during a 12-week period. Social communication and task completion also improved. For children with ASD and moderate to severe behavior problems, parent-implemented FCT using telehealth significantly reduced problem behavior while ongoing interventions typically did not.