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Autism RCT

Cally Kent, Reinie Cordier, Annette Joosten, Sarah Wilkes-Gillan, Anita Bundy
BACKGROUND/AIM: Children with autism spectrum disorder (ASD) frequently demonstrate impaired play skills and poor quality social interactions compared to typically developing peers. Complex interventions to improve play skills should be investigated with randomised control trials (RCT) where possible to support evidence-based practice for occupational therapists. Prior to a RCT, multiple feasibility studies are recommended to identify barriers to the trial. The aim of this study is to adapt a complex intervention to improve play skills in children with ASD and investigate the feasibility of conducting a RCT...
March 11, 2018: Australian Occupational Therapy Journal
Stavros Stivaros, Shruti Garg, Maria Tziraki, Ying Cai, Owen Thomas, Joseph Mellor, Andrew A Morris, Carly Jim, Karolina Szumanska-Ryt, Laura M Parkes, Hamied A Haroon, Daniela Montaldi, Nicholas Webb, John Keane, Francisco X Castellanos, Alcino J Silva, Sue Huson, Stephen Williams, D Gareth Evans, Richard Emsley, Jonathan Green
Background: Neurofibromatosis 1 (NF1) is a monogenic model for syndromic autism. Statins rescue the social and cognitive phenotype in animal knockout models, but translational trials with subjects > 8 years using cognition/behaviour outcomes have shown mixed results. This trial breaks new ground by studying statin effects for the first time in younger children with NF1 and co-morbid autism and by using multiparametric imaging outcomes. Methods: A single-site triple-blind RCT of simvastatin vs...
2018: Molecular Autism
William Thompson, Ginny Russell, Genevieve Baragwanath, Justin Matthews, Bijay Vaidya, Jo Thompson-Coon
BACKGROUND: In the last two decades, several studies have examined the association between maternal thyroid hormone insufficiency during pregnancy and neurodevelopmental disorders in children and shown conflicting results. AIM: This systematic review aimed to assess the evidence for an association between maternal thyroid hormone insufficiency during pregnancy and neurodevelopmental disorders in children. We also sought to assess whether levothyroxine treatment for maternal thyroid hormone insufficiency improves child neurodevelopment outcomes...
January 11, 2018: Clinical Endocrinology
Ailsa Russell, Kate Cooper, Stephen Barton, Ian Ensum, Daisy Gaunt, Jeremy Horwood, Barry Ingham, David Kessler, Chris Metcalfe, Jeremy Parr, Dheeraj Rai, Nicola Wiles
INTRODUCTION: High rates of co-occurring depression are reported in autism spectrum disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive-behavioural interventions adapted for ASD have been effective for anxiety problems. There have been evaluation studies of group cognitive-behavioural therapy for co-occurring depression, but no randomised trials investigating low-intensity psychological interventions as recommended in clinical guidelines for mild-moderate depression...
December 3, 2017: BMJ Open
Benjamin L Handen, Evdokia Anagnostou, Michael G Aman, Kevin B Sanders, James Chan, Jill A Hollway, Jessica Brian, L Eugene Arnold, Lucia Capano, Craig Williams, Jessica A Hellings, Eric Butter, Deepali Mankad, Rameshwari Tumuluru, Jessica Kettel, Cassandra R Newsom, Naomi Peleg, Dina Odrobina, Sarah McAuliffe-Bellin, Sarah Marler, Taylor Wong, Alexis Wagner, Stasia Hadjiyannakis, Eric A Macklin, Jeremy Veenstra-VanderWeele
OBJECTIVE: A previous study reported on a 16-week placebo-controlled, randomized clinical trial (RCT) of metformin for weight stabilization in 61 children and adolescents 6 to 17 years old with autism spectrum disorder who were prescribed atypical antipsychotics. The present study describes the results of a 16-week open-label extension. METHOD: Fifty-two participants from the acute trial (85%) entered the extension; 22 had been on metformin during the initial RCT and 30 had been on placebo...
October 2017: Journal of the American Academy of Child and Adolescent Psychiatry
Yong-Jiang Li, Ya-Min Li, Da-Xiong Xiang
PURPOSE: Nutritional supplements have been used for correction of deficiencies that may occur in patient with autism spectrum disorder (ASD) and to improve core symptoms. We aim to provide current best evidence about supplements for nutritional deficiencies and core symptoms in children with ASD and to evaluate the effectiveness and safety. METHODS: A systematic literature search of scientific databases was performed to retrieve relevant randomized controlled trials...
September 7, 2017: European Journal of Nutrition
Silvana E Mengoni, Karen Irvine, Deepshikha Thakur, Garry Barton, Kerstin Dautenhahn, Karen Guldberg, Ben Robins, David Wellsted, Shivani Sharma
INTRODUCTION: Interventions using robot-assisted therapy may be beneficial for the social skills development of children with autism spectrum disorder (ASD); however, randomised controlled trials (RCTs) are lacking. The present research aims to assess the feasibility of conducting an RCT evaluating the effectiveness of a social skills intervention using Kinesics and Synchronisation in Personal Assistant Robotics (Kaspar) with children with ASD. METHODS AND ANALYSIS: Forty children will be recruited...
June 22, 2017: BMJ Open
Conor P Kerley, Clare Power, Louise Gallagher, David Coghlan
OBJECTIVES: Data suggest a potential role for vitamin D in autism spectrum disorder (ASD). We wanted to assess the effect of vitamin D3 supplementation compared with placebo in children with ASD. DESIGN: This was a double-blind, randomised, placebo-controlled trial. SETTING: A paediatric outpatient centre at high latitude over the winter season in Dublin, Ireland (53°N). PATIENTS: 42 children with ASD. INTERVENTIONS: 2000 IU vitamin D3 supplementation or placebo daily for 20 weeks...
November 2017: Archives of Disease in Childhood
Jessica A Brian, Isabel M Smith, Lonnie Zwaigenbaum, Susan E Bryson
To evaluate the efficacy of the Social ABCs parent-mediated intervention for toddlers with suspected or confirmed autism spectrum disorder (ASD), through a cross-site randomized control trial, sixty-three parent-toddler dyads (toddler age: 16-30 months) were randomized into treatment (Social ABCs) or control (service-as-usual) conditions. Video data were obtained at three key time-points: Baseline; Post-training (PT; week 12); and Follow-Up (week 24). Analyses included 62 dyads. Treatment allocation significantly accounted for PT gains, all favouring the Treatment group, in (1) child functional vocal responsiveness to parent prompts (R(2)  = 0...
October 2017: Autism Research: Official Journal of the International Society for Autism Research
Nila Sathe, Jeffrey C Andrews, Melissa L McPheeters, Zachary E Warren
CONTEXT: Children with autism spectrum disorder (ASD) frequently use special diets or receive nutritional supplements to treat ASD symptoms. OBJECTIVES: Our objective was to evaluate the effectiveness and safety of dietary interventions or nutritional supplements in ASD. DATA SOURCES: Databases, including Medline and PsycINFO. STUDY SELECTION: Two investigators independently screened studies against predetermined criteria...
June 2017: Pediatrics
Andrew J O Whitehouse, Joanna Granich, Gail Alvares, Margherita Busacca, Matthew N Cooper, Alena Dass, Thi Duong, Rajes Harper, Wendy Marshall, Amanda Richdale, Tania Rodwell, David Trembath, Pratibha Vellanki, Dennis W Moore, Angelika Anderson
BACKGROUND: Technology-based interventions for Autism Spectrum Disorder (ASD) have proliferated, but few have been evaluated within the context of a randomised controlled trial (RCT). This RCT evaluated the efficacy of one technology-based early intervention programme (Therapy Outcomes By You; TOBY) in young children with ASD. METHODS: TOBY is an app-based learning curriculum designed for children and parents as a complement to early behavioural intervention. Eighty children (16 female) were recruited to this RCT within 12 months of receiving a diagnosis of ASD (M age = 3...
May 25, 2017: Journal of Child Psychology and Psychiatry, and Allied Disciplines
Tristram Smith, Suzannah Iadarola, David S Mandell, Robin Harwood, Connie Kasari
OBJECTIVE: To illustrate the process of community-partnered participatory research to develop and evaluate interventions for children with autism in urban school districts. METHODS: We formed partnerships of school personnel, parents, and researchers to guide the project. We then conducted focus groups, key informant interviews, and town halls to explore how public schools currently serve students with autism. We used findings from these activities to adapt interventions for public schools...
August 2017: Academic Pediatrics
J Green, A Pickles, G Pasco, R Bedford, M W Wan, M Elsabbagh, V Slonims, T Gliga, E J H Jones, C H M Cheung, T Charman, M H Johnson
BACKGROUND: There has been increasing interest in the potential for pre-emptive interventions in the prodrome of autism, but little investigation as to their effect. METHODS: A two-site, two-arm assessor-blinded randomised controlled trial (RCT) of a 12-session parent-mediated social communication intervention delivered between 9 and 14 months of age (Intervention in the British Autism Study of Infant Siblings-Video Interaction for Promoting Positive Parenting), against no intervention...
April 10, 2017: Journal of Child Psychology and Psychiatry, and Allied Disciplines
Danielle M J de Veld, Patricia Howlin, Elske Hoddenbach, Fleur Mulder, Imke Wolf, Hans M Koot, Ramón Lindauer, Sander Begeer
This RCT investigated whether the effect of a Theory of Mind (ToM) intervention for children with ASD was moderated by parental education level and employment, family structure, and parental ASD. Children with autism aged 8-13 years (n = 136) were randomized over a waitlist control or treatment condition. At posttest, children in the treatment condition had more ToM knowledge, showed fewer autistic features, and more ToM-related behavior than children in the control condition. Children who had one or two parents with at least a college degree, and children with parents not diagnosed with/suspected of having ASD themselves benefitted from the training...
July 2017: Journal of Autism and Developmental Disorders
Sammy Roording-Ragetlie, Helen Klip, Jan Buitelaar, Dorine Slaats-Willemse
BACKGROUND: Working memory training (WMT) has been shown to offer therapeutic benefits to both patients with Attention-Deficit Hyperactivity Disorder (ADHD) and patients with mild to borderline Intellectual Disabilities (MBID; 60 < IQ < 85). However, robust evidence for transfer effects and treatment benefits of WMT over placebo training are lacking. Owing to the nature of double-blind research designs in RCTs, children have received non-specific coaching not based on their actual training performance...
March 28, 2017: BMC Psychiatry
John Jacob Cannell
An increasing amount of evidence points to the possibility that gestational and early childhood vitamin D deficiency [25(OH)D < 40 ng/ml] cause some cases of autism. Vitamin D is metabolized into a seco-steroid hormone that regulates about 3% of the 26,000 genes in the coding human genome. It is also a neurosteroid that is active in brain development, having effects on cellular proliferation, differentiation, calcium signaling, neurotrophic and neuroprotective actions; it also appears to have an effect on neurotransmission and synaptic plasticity...
June 2017: Reviews in Endocrine & Metabolic Disorders
Andrea Horvath, Jan Łukasik, Hania Szajewska
Background: Effective treatments for the core symptoms of autism spectrum disorder (ASD) are still lacking.Objective: We aimed to update the data on the effectiveness of ω-3 (n-3) fatty acid (FA) supplementation as a treatment for ASD.Methods: The Cochrane Library, MEDLINE, and EMBASE databases were systematically searched up until August 2016 with no language restrictions for randomized controlled trials (RCTs) comparing ω-3 FA supplementation with placebo or with no supplementation. Participants were children diagnosed with ASD...
March 2017: Journal of Nutrition
M Hochhauser, P L Weiss, E Gal
Adolescents with autism spectrum disorder (ASD) have particular difficulty in negotiating conflict. A randomized control trial (RCT) was carried out to determine whether the negotiation strategies of adolescents with ASD would be enhanced via a 6-week intervention based on a video modeling application. Adolescents with ASD, aged 12-18 years, were randomly divided into an intervention group (n = 36) and a non-treatment control group (n = 25). Participants' negotiating strategies prior to and following the intervention were measured using the Five Factor Negotiation Scale (FFNS; Nakkula & Nikitopoulos, 1999) and the ConflicTalk questionnaire (Kimsey & Fuller, 2003)...
December 21, 2016: Assistive Technology: the Official Journal of RESNA
Anna R Hodgson, Victoria Grahame, Deborah Garland, Fiona Gaultier, Jan Lecouturier, Ann Le Couteur
BACKGROUND: Early intervention for autism spectrum disorder (ASD) tends to focus on enhancing social communication skills. We report data collected via focus group discussions as part of a feasibility and acceptability pilot randomized controlled trial (RCT) about a new parent group intervention to manage restricted and repetitive behaviours (RRB) in young children with ASD. METHODS: The focus groups were led by two independent facilitators and followed a semi-structured topic guide with the aim of considering three key topics: experiences of participating in a RCT, opinions about the intervention and the impact of the intervention on the participants, their children and the family...
December 19, 2016: Journal of Applied Research in Intellectual Disabilities: JARID
Marcus L Thomeer, Christopher Lopata, James P Donnelly, Adam Booth, Andrew Shanahan, Veronica Federiconi, Christin A McDonald, Jonathan D Rodgers
This community effectiveness randomized clinical trial examined the feasibility and effectiveness of a comprehensive psychosocial treatment, summerMAX, when implemented by a community agency. Fifty-seven high-functioning children (48 male, 9 female), ages 7-12 years with autism spectrum disorder participated in this study. The 5-week summerMAX treatment included instruction and therapeutic activities targeting social/social-communication skills, interpretation of nonliteral language skills, face-emotion recognition skills, and interest expansion...
December 5, 2016: Journal of Clinical Child and Adolescent Psychology
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