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"Autistic Disorder"
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Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study
Rationale
Standard therapeutic approaches to reduce social anxiety in autistic adults have limited effectiveness. Since 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy shows promise as a treatment for other anxiety disorders, a blinded, placebo-controlled pilot study was conducted.
Objectives
To explore feasibility and safety of MDMA-assisted psychotherapy for reduction of social fear and avoidance that are common in the autistic population.
Methods
Autistic adults with marked to very severe social anxiety were randomized to receive MDMA (75 to 125 mg,
n
= 8) or inactive placebo (0 mg,
n
= 4) during two 8-h psychotherapy sessions (experimental sessions) in a controlled clinical setting. Double-blinded experimental sessions were spaced approximately 1 month apart with 3 non-drug psychotherapy sessions following each. The primary outcome was change in Leibowitz Social Anxiety Scale (LSAS) Total scores from Baseline to one month after the second experimental session. Outcomes were measured again six months after the last experimental session.
Results
Improvement in LSAS scores from baseline to the primary endpoint was significantly greater for MDMA group compared to the placebo group (
P
= 0.037), and placebo-subtracted Cohen’s
d
effect size was very large (
d
= 1.4, CI − 0.074, 2.874). Change in LSAS scores from baseline to 6-month follow-up showed similar positive results (
P
= 0.036), with a Cohen’s
d
effect size of 1.1 (CI − 0.307, 2.527). Social anxiety remained the same or continued to improve slightly for most participants in the MDMA group after completing the active treatment phase.
Conclusions
This pilot trial demonstrated rapid and durable improvement in social anxiety symptoms in autistic adults following MDMA-assisted psychotherapy. Initial safety and efficacy outcomes support expansion of research into larger samples to further investigate this novel treatment for social anxiety.
Trial registration
clinicaltrials.gov
identifier, NCT02008396
Journal Article
Parent-mediated communication-focused treatment in children with autism (PACT): a randomised controlled trial
Results of small trials suggest that early interventions for social communication are effective for the treatment of autism in children. We therefore investigated the efficacy of such an intervention in a larger trial.
Children with core autism (aged 2 years to 4 years and 11 months) were randomly assigned in a one-to-one ratio to a parent-mediated communication-focused (Preschool Autism Communication Trial [PACT]) intervention or treatment as usual at three specialist centres in the UK. Those assigned to PACT were also given treatment as usual. Randomisation was by use of minimisation of probability in the marginal distribution of treatment centre, age (≤42 months or >42 months), and autism severity (Autism Diagnostic Observation Schedule-Generic [ADOS-G] algorithm score 12–17 or 18–24). Primary outcome was severity of autism symptoms (a total score of social communication algorithm items from ADOS-G, higher score indicating greater severity) at 13 months. Complementary secondary outcomes were measures of parent-child interaction, child language, and adaptive functioning in school. Analysis was by intention to treat. This study is registered as an
International Standard Randomised Controlled Trial, number
ISRCTN58133827.
152 children were recruited. 77 were assigned to PACT (London [n=26], Manchester [n=26], and Newcastle [n=25]); and 75 to treatment as usual (London [n=26], Manchester [n=26], and Newcastle [n=23]). At the 13-month endpoint, the severity of symptoms was reduced by 3·9 points (SD 4·7) on the ADOS-G algorithm in the group assigned to PACT, and 2·9 (3·9) in the group assigned to treatment as usual, representing a between-group effect size of −0·24 (95% CI −0·59 to 0·11), after adjustment for centre, sex, socioeconomic status, age, and verbal and non-verbal abilities. Treatment effect was positive for parental synchronous response to child (1·22, 0·85 to 1·59), child initiations with parent (0·41, 0·08 to 0·74), and for parent-child shared attention (0·33, −0·02 to 0·68). Effects on directly assessed language and adaptive functioning in school were small.
On the basis of our findings, we cannot recommend the addition of the PACT intervention to treatment as usual for the reduction of autism symptoms; however, a clear benefit was noted for parent-child dyadic social communication.
UK Medical Research Council, and UK Department for Children, Schools and Families.
Journal Article
The Coping Cat Program for Children with Anxiety and Autism Spectrum Disorder: A Pilot Randomized Controlled Trial
The purpose of this pilot study was to evaluate whether a modified version of the Coping Cat program could be effective in reducing anxiety in children with autism spectrum disorder (ASD). Twenty-two children (ages 8–14; IQ ≥ 70) with ASD and clinically significant anxiety were randomly assigned to 16 sessions of the Coping Cat program (cognitive-behavioral therapy; CBT) or a 16-week waitlist. Children in the CBT condition evidenced significantly larger reductions in anxiety than those in the waitlist. Treatment gains were largely maintained at two-month follow-up. Results provide preliminary evidence that a modified version of the Coping Cat program may be a feasible and effective program for reducing clinically significant levels of anxiety in children with high-functioning ASD.
Journal Article
Pilot study of probiotic/colostrum supplementation on gut function in children with autism and gastrointestinal symptoms
Over half of all children with autism spectrum disorders (ASD) have gastrointestinal (GI) co-morbidities including chronic constipation, diarrhea, and irritable bowel syndrome. The severity of these symptoms has been correlated with the degree of GI microbial dysbiosis. The study objective was to assess tolerability of a probiotic (Bifidobacterium infantis) in combination with a bovine colostrum product (BCP) as a source of prebiotic oligosaccharides and to evaluate GI, microbiome and immune factors in children with ASD and GI co-morbidities. This pilot study is a randomized, double blind, controlled trial of combination treatment (BCP + B. infantis) vs. BCP alone in a cross-over study in children ages 2-11 with ASD and GI co-morbidities (n = 8). This 12-week study included 5 weeks of probiotic-prebiotic supplementation, followed by a two-week washout period, and 5 weeks of prebiotic only supplementation. The primary outcome of tolerability was assessed using validated questionnaires of GI function and atypical behaviors, along with side effects. Results suggest that the combination treatment is well-tolerated in this cohort. The most common side effect was mild gassiness. Some participants on both treatments saw a reduction in the frequency of certain GI symptoms, as well as reduced occurrence of particular aberrant behaviors. Improvement may be explained by a reduction in IL-13 and TNF-α production in some participants. Although limited conclusions can be drawn from this small pilot study, the results support the need for further research into the efficacy of these treatments.
Journal Article
Defining autism : a guide to brain, biology, and behavior
\"Drawing on the most up-to-date research on autism, this incisive book argues that while there are different causes and variations of autism, there is in fact one biological autism. By examining developmental and genetic factors and investigating lesser known autism-related syndromes, it clears away misconceptions surrounding this complex condition\"-- Back cover.
BOOK
The effects of an integrated sports and arts intervention on response joint attention (RJA) eye-movement characteristics in children with mild autism
This study examines whether integrating sports and arts interventions enhances response joint attention (RJA) in children with mild autism and provides insights for diversifying intervention strategies for autism. 2024.6–2024.12,Twenty-four children with autism, aged 6–12 years, were recruited from an autism association in Anhui Province, China. Participants were randomized using a computer-generated sequence (allocation concealed from assessors) assigned to an experimental group (n = 12) or a control group (n = 12). Over 12 weeks, the experimental group participated in basketball and drawing lessons four times a week for 60 min per session, while the control group engaged only in routine activities and structured teaching provided by their school and the association. RJA performance was assessed pre- and post-intervention using eye-tracking technology, analyzing key metrics: time to first fixation (TFF), fixation count (FC), total fixation duration (TFD), total visit duration (TVD), visit count (VC), and the ratio of correct to incorrect for first responses. Post-intervention, the experimental group showed significantly greater improvements in RJA performance than the control group. Key metrics for the experimental group included TFF (0.52 ± 0.79), FC (36.35 ± 6.34), TFD (11.05 ± 1.33), TVD (17.05 ± 2.33), VC (24.25 ± 2.49), and correct-to-incorrect ratio (1.1 ± 0.1), all of which outperformed the control group: TFF (0.59 ± 0.11), FC (30.83 ± 2.14), TFD (9.47 ± 1.38), TVD (15.42 ± 1.51), VC (20.33 ± 1.87), and correct-to-incorrect ratio (0.97 ± 0.08),partialη
2
ranged from 0.25 to 0.78, with
P
< 0.05. Integrating sports and arts interventions significantly improves RJA in children with autism, highlighting the potential of these methods in enhancing attention-related behaviors.
Journal Article