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Randomized Controlled Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder.

ABSTRACT: This study expands previous equine-assisted intervention research by evaluating the effectiveness of therapeutic horseback riding (THR) on self-regulation, socialization, communication, adaptive, and motor behaviors in children with autism spectrum disorder (ASD).Participants with ASD (aged 6-16 years; N = 127) were stratified by nonverbal IQ standard scores (?85 or >85) and randomized to 1 of 2 groups for 10 weeks: THR intervention or a barn activity (BA) control group without horses that used similar methods. The fidelity of the THR intervention was monitored. Participants were evaluated within 1 month pre- and postintervention by raters blinded to intervention conditions and unblinded caregiver questionnaires. During the intervention, caregivers rated participants' behaviors weekly.Intent-to-treat analysis conducted on the 116 participants who completed a baseline assessment (THR n = 58; BA control n = 58) revealed significant improvements in the THR group compared to the control on measures of irritability (primary outcome) (p = .02; effect size [ES] = 0.50) and hyperactivity (p = .01; ES = 0.53), beginning by week 5 of the intervention. Significant improvements in the THR group were also observed on a measure of social cognition (p = .05; ES = 0.41) and social communication (p = .003; ES = 0.63), along with the total number of words (p = .01; ES = 0.54) and new words (p = .01; ES = 0.54) spoken during a standardized language sample. Sensitivity analyses adjusting for age, IQ, and per protocol analyses produced consistent results.This is the first large-scale, randomized, controlled trial demonstrating efficacy of THR for the ASD population, and findings are consistent with previous equine-assisted intervention studies.Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder; http://clinicaltrials.gov; NCT02301195.

SUBMITTER: Gabriels RL

PROVIDER: S-EPMC4475278 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Randomized Controlled Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder.

Gabriels Robin L RL Pan Zhaoxing Z Dechant Briar B Agnew John A JA Brim Natalie N Mesibov Gary G

Journal of the American Academy of Child and Adolescent Psychiatry 20150505 7

<h4>Objective</h4>This study expands previous equine-assisted intervention research by evaluating the effectiveness of therapeutic horseback riding (THR) on self-regulation, socialization, communication, adaptive, and motor behaviors in children with autism spectrum disorder (ASD).<h4>Method</h4>Participants with ASD (aged 6-16 years; N = 127) were stratified by nonverbal IQ standard scores (≤85 or >85) and randomized to 1 of 2 groups for 10 weeks: THR intervention or a barn activity (BA) contro ...[more]

PMID: 26088658

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Project description:This paper presents 6-month follow-up data of 44% (N = 64/116) of participants (ages 6-16 years) with a diagnosis of autism spectrum disorder, who participated in a previously-published randomized controlled trial of therapeutic horseback riding (THR) compared to a no-horse contact active control. The objective of this study was to examine whether significant improvements of irritability, hyperactivity, social, and communication behaviors observed in participants randomized to receive a 10-week manual-based THR intervention were sustained 6 months after the intervention conclusion. Participants' caregivers from both the THR (n = 36) and active control (n = 28) groups completed a measure of irritability and hyperactivity behaviors (primary outcome variables). Additionally, only the THR group participants completed the full battery of study outcomes assessments. Between group comparisons examining the extended interval from baseline (1-month pre-intervention assessment) to 6-months after the intervention revealed that the THR group maintained reductions in irritability behavior at a 0.1 level (effect size = 0.32, p = 0.07). (Effect size = 0.32, p = 0.07), which was 73% of efficacy preserved from the primary post-intervention endpoint (within 1-month post-intervention). Hyperactivity behaviors did not sustain this same trend. Comparisons from baseline and 6-months after the intervention revealed that the THR group sustained significant initial improvements made in social and communication behaviors, along with number of words and different words spoken during a standard language sample. This is the first known study to examine and demonstrate the longer-term effects of THR for individuals with ASD and warrants a more thorough evaluation of whether the effects of THR are maintained for at least 6-months after the intervention compared to a control.Clinical trial registration informationTrial of Therapeutic Horseback Riding in Children and Adolescents with Autism Spectrum Disorder; http://clinicaltrials.gov; NCT02301195.

Project description:We aimed to determine whether results of our prior randomized control trial [RCT; NCT02301195, (1)] of Therapeutic Horseback Riding (THR) for children and adolescents with autism spectrum disorder (ASD) could be replicated at a different riding center and if treatment effects also included differences in the expression of associations between problem behavior and the activity of the hypothalamic-pituitary-adrenal (HPA) axis. Participants with ASD (N = 16) ages 6-16 years were randomized by nonverbal intelligence quotient to either a 10-week THR group (n = 8) or no horse interaction barn activity (BA) control group (n = 8). Outcome measures were a standard speech-language sample and caregiver-report of aberrant and social behaviors. Participants' saliva was sampled weekly at a consistent afternoon time immediately pre- and 20 min' post-condition (later assayed for cortisol). Intent-to-treat analysis revealed that compared to controls, THR participants had significant improvements in hyperactivity, and social awareness, and significant improvements at the 0.1 significance level in irritability and social communication behaviors. There were no significant improvements in number of words or new words spoken during the standard language sample. Linear mixed effects model analysis indicated that greater weekly pre-lesson irritability levels were associated with smaller post-lesson reduction in salivary cortisol levels, and greater weekly pre-lesson hyperactivity levels were associated with smaller cortisol reduction in the THR group, but not in the BA control group. The findings represent a partial replication of prior results (1), extend prior observations to include THR effects on biobehavioral relationships and suggest that cortisol could be a target mediator for THR effects on irritability and hyperactivity behaviors in youth with ASD. Clinical Trial Registration: Trial of Therapeutic Horseback Riding in Children and Adolescents with Autism Spectrum Disorder; http://clinicaltrials.gov, identifier: NCT02301195.

Project description:BackgroundExperimental studies and small clinical trials have suggested that treatment with intranasal oxytocin may reduce social impairment in persons with autism spectrum disorder. Oxytocin has been administered in clinical practice to many children with autism spectrum disorder.MethodsWe conducted a 24-week, placebo-controlled phase 2 trial of intranasal oxytocin therapy in children and adolescents 3 to 17 years of age with autism spectrum disorder. Participants were randomly assigned in a 1:1 ratio, with stratification according to age and verbal fluency, to receive oxytocin or placebo, administered intranasally, with a total target dose of 48 international units daily. The primary outcome was the least-squares mean change from baseline on the Aberrant Behavior Checklist modified Social Withdrawal subscale (ABC-mSW), which includes 13 items (scores range from 0 to 39, with higher scores indicating less social interaction). Secondary outcomes included two additional measures of social function and an abbreviated measure of IQ.ResultsOf the 355 children and adolescents who underwent screening, 290 were enrolled. A total of 146 participants were assigned to the oxytocin group and 144 to the placebo group; 139 and 138 participants, respectively, completed both the baseline and at least one postbaseline ABC-mSW assessments and were included in the modified intention-to-treat analyses. The least-squares mean change from baseline in the ABC-mSW score (primary outcome) was -3.7 in the oxytocin group and -3.5 in the placebo group (least-squares mean difference, -0.2; 95% confidence interval, -1.5 to 1.0; P = 0.61). Secondary outcomes generally did not differ between the trial groups. The incidence and severity of adverse events were similar in the two groups.ConclusionsThis placebo-controlled trial of intranasal oxytocin therapy in children and adolescents with autism spectrum disorder showed no significant between-group differences in the least-squares mean change from baseline on measures of social or cognitive functioning over a period of 24 weeks. (Funded by the National Institute of Child Health and Human Development; SOARS-B ClinicalTrials.gov number, NCT01944046.).

Project description:This study was a 10-week double-blind, placebo-controlled pilot trial of mirtazapine for anxiety in youth with autism spectrum disorder (ASD). Participants were ages 5 to 17 years with ASD and clinically significant anxiety (Pediatric Anxiety Rating Scale [PARS] score ≥10). Thirty participants were randomized to mirtazapine (7.5-45 mg/day) or placebo in a 2:1 ratio. The co-primary outcome measures were the PARS and the Clinical Global Impressions-Improvement subscale (CGI-I). Mirtazapine resulted in a statistically significant within group decrease in anxiety on the PARS (ES 1.76, p < 0.001). The improvement in PARS score for mirtazapine versus placebo was clinically meaningful but not statistically significant (ES = 0.63, p = 0.64). Forty-seven percent of participants assigned to mirtazapine (95% CI 22%: 74%) and 20% assigned to placebo (95% CI 2%: 60%) were rated "much improved" (CGI-I = 2) or "very much improved" (CGI-I = 1) for anxiety, p = 0.46. No statistically significant differences in mean 10-week changes between mirtazapine and placebo occurred on any outcome measure. There were no statistically significant differences in adverse effect frequency between mirtazapine and placebo. The results are consistent with mirtazapine's safety and tolerability and meet three of four pre-specified indicators of efficacy (statistically significant change in total PARS score for mirtazapine, numerically greater reduction in total PARS score for mirtazapine than placebo, numerically higher number of responders to mirtazapine than placebo, but not greater than 50% of participants receiving mirtazapine rated as responders). Implementation of a larger randomized controlled trial of mirtazapine for the treatment of anxiety in this population is supported.Clinical trial registration information: Mirtazapine Treatment of Anxiety in Children and Adolescents with Pervasive Developmental Disorders; https://clinicaltrials.gov ; NCT01302964.

Project description:BackgroundSulforaphane (SF), an isothiocyanate in broccoli, has potential benefits relevant to autism spectrum disorder (ASD) through its effects on several metabolic and immunologic pathways. Previous clinical trials of oral SF demonstrated positive clinical effects on behavior in young men and changes in urinary metabolomics in children with ASD.MethodsWe conducted a 15-week randomized parallel double-blind placebo-controlled clinical trial with 15-week open-label treatment and 6-week no-treatment extensions in 57 children, ages 3-12 years, with ASD over 36 weeks. Twenty-eight were assigned SF and 29 received placebo (PL). Clinical effects, safety and tolerability of SF were measured as were biomarkers to elucidate mechanisms of action of SF in ASD.ResultsData from 22 children taking SF and 23 on PL were analyzed. Treatment effects on the primary outcome measure, the Ohio Autism Clinical Impressions Scale (OACIS), in the general level of autism were not significant between SF and PL groups at 7 and 15 weeks. The effect sizes on the OACIS were non-statistically significant but positive, suggesting a possible trend toward greater improvement in those on treatment with SF (Cohen's d 0.21; 95% CI - 0.46, 0.88 and 0.10; 95% CI - 0.52, 0.72, respectively). Both groups improved in all subscales when on SF during the open-label phase. Caregiver ratings on secondary outcome measures improved significantly on the Aberrant Behavior Checklist (ABC) at 15 weeks (Cohen's d - 0.96; 95% CI - 1.73, - 0.15), but not on the Social Responsiveness Scale-2 (SRS-2). Ratings on the ABC and SRS-2 improved with a non-randomized analysis of the length of exposure to SF, compared to the pre-treatment baseline (p < 0.001). There were significant changes with SF compared to PL in biomarkers of glutathione redox status, mitochondrial respiration, inflammatory markers and heat shock proteins. Clinical laboratory studies confirmed product safety. SF was very well tolerated and side effects of treatment, none serious, included rare insomnia, irritability and intolerance of the taste and smell.LimitationsThe sample size was limited to 45 children with ASD and we did not impute missing data. We were unable to document significant changes in clinical assessments during clinical visits in those taking SF compared to PL. The clinical results were confounded by placebo effects during the open-label phase.ConclusionsSF led to small yet non-statistically significant changes in the total and all subscale scores of the primary outcome measure, while for secondary outcome measures, caregivers' assessments of children taking SF showed statistically significant improvements compared to those taking PL on the ABC but not the SRS-2. Clinical effects of SF were less notable in children compared to our previous trial of a SF-rich preparation in young men with ASD. Several of the effects of SF on biomarkers correlated to clinical improvements. SF was very well tolerated and safe and effective based on our secondary clinical measures.Trial registrationThis study was prospectively registered at clinicaltrials.gov (NCT02561481) on September 28, 2015. Funding was provided by the U.S. Department of Defense.

Dataset Information

Randomized Controlled Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder.

Publications

Randomized Controlled Trial of Therapeutic Horseback Riding in Children and Adolescents With Autism Spectrum Disorder.

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