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      Cognitive-behavioral family therapy as psychoeducation for adolescents with high-functioning autism spectrum disorders: Aware and Care for my Autistic Traits (ACAT) program study protocol for a pragmatic multisite randomized controlled trial

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          Abstract

          Background

          One aim of an autism spectrum disorder (ASD) diagnosis is to obtain special support for the disorder, though this does not guarantee practical support. We developed a psychoeducational program using cognitive-behavioral therapy (CBT) and Aware and Care for my Autistic Traits (ACAT) for Japanese adolescents with high-functioning ASD and their parents.

          Methods

          This multisite study is a randomized controlled trial. In total, 24 participants will be assigned to the ACAT group and 24 to the treatment-as-usual (TAU) group. The ACAT group will receive a weekly 100-min session for 6 weeks, regular medical care, and one follow-up session. In this ongoing clinical trial, we will compare the scores of the measures recorded in the pre- and post-intervention stages between the ACAT and TAU groups. A total of 41 patients out of a target of 48 have participated in the trial to date. The primary outcome measure is the Autism Knowledge Questionnaire. Secondary outcome measures include Barriers to Access to Care Evaluation 3rd Edition, the Strengths and Difficulties Questionnaire, the Vineland Adaptive Behavior Scales second edition, the Parenting Resilience Elements Questionnaire, the General Health Questionnaire 12, and the Depression Self-Rating Scale for Children assessments, as well as an electroencephalographic recording.

          Discussion

          It is expected that participants in the ACAT group will significantly increase their self-understanding and awareness of ASD symptoms compared to those in the TAU group. Additionally, the ACAT group is expected to exhibit improved social adaptation and mental health if children and parents are able to better understand the ASD characteristics through sessions. This intervention will contribute to the establishment of an effective evidence-based treatment strategy for adolescents with ASD.

          Trial registration

          UMIN Register 000029851. Registered on January 06, 2018

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          Most cited references43

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          Diagnostic and Statistical Manual of Mental Disorders

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            SPIRIT 2013 statement: defining standard protocol items for clinical trials.

            The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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              The Strengths and Difficulties Questionnaire: A Research Note

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                Author and article information

                Contributors
                fumiyooshima@gmail.com
                w.mandy@ucl.ac.uk
                noriko-t@ipc.fukushima-u.ac.jp
                aki.tsuchiyagaito@gmail.com
                kuwabarahitoshi@yahoo.co.jp
                shiina-akihiro@faculty.chiba-u.jp
                mseto.yang@gmail.com
                thehongos@bird.ocn.ne.jp
                yuii.iwama@gmail.com
                hirano@chiba-u.jp
                csutoh@graduate.chiba-u.jp
                k.taguchi@chiba-u.jp
                tokiy2012@gmail.com
                ykawasaki@chiba-u.jp
                yoshihito.ozawa@chiba-u.jp
                j.masuya@gmail.com
                n-sato@ipc.fukushima-u.ac.jp
                sh-nakamura@ipc.fukushima-u.ac.jp
                m-kuno@chiba-u.jp
                j09032264200@yahoo.co.jp
                otanit@chiba-u.jp
                dmatsuzawa@faculty.chiba-u.jp
                inadanaoko@hotmail.co.jp
                pr6m-krd@asahi-net.or.jp
                umika@yahoo.co.jp
                arinobu.h@gmail.com
                akikon@chiba-u.jp
                eiji@faculty.chiba-u.jp
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                29 September 2020
                29 September 2020
                2020
                : 21
                : 814
                Affiliations
                [1 ]GRID grid.136304.3, ISNI 0000 0004 0370 1101, Research Center for Child Mental Development, , Chiba University, ; 1-8-1 Inohana Chuouku, Chiba, 260-8670 Japan
                [2 ]GRID grid.83440.3b, ISNI 0000000121901201, Research Department of Clinical, Educational & Health Psychology, , University College London, ; London, UK
                [3 ]GRID grid.443549.b, ISNI 0000 0001 0603 1148, Fukushima University Child Mental Health-Care Center, ; Fukushima, Japan
                [4 ]Laureate Instituto for Brain Research, Tulsa, OK USA
                [5 ]GRID grid.505613.4, Department of Psychiatry, , Hamamatsu University School of Medicine, ; Shizuoka, Japan
                [6 ]GRID grid.411500.1, Chiba University Center for Forensic Mental Health, ; Chiba, Japan
                [7 ]GRID grid.411321.4, ISNI 0000 0004 0632 2959, Biostatistics Section, Clinical Research Center, , Chiba University Hospital, ; Chiba, Japan
                [8 ]GRID grid.412784.c, ISNI 0000 0004 0386 8171, Department of Psychiatry, , Tokyo Medical University Ibaraki Medical Center, ; Ibaraki, Japan
                [9 ]GRID grid.264706.1, ISNI 0000 0000 9239 9995, Department of Psychology, Faculty of Liberal Arts, , Teikyo University, ; Tokyo, Japan
                [10 ]GRID grid.444512.2, Department of Human Care, , Nagoya University of Arts and Sciences, ; Nagoya, Japan
                [11 ]Department of Psychiatry, Hibarigaoka Hospital, Fukushima, Japan
                [12 ]Hori Mental Clinic, Fukushima, Japan
                Article
                4750
                10.1186/s13063-020-04750-z
                7526096
                32993775
                f73a6a78-7c81-4caa-89b8-cdf49858e656
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 19 March 2020
                : 17 September 2020
                Funding
                Funded by: Association of Japanese Clinical Psychology
                Award ID: 2017 S-1
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2020

                Medicine
                high-functioning autism spectrum disorder,randomized controlled trial,cognitive-behavioral family therapy,psychoeducation

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