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      Examination of Web-Based Single-Session Growth Mindset Interventions for Reducing Adolescent Anxiety: Study Protocol of a 3-Arm Cluster Randomized Controlled Trial

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          Abstract

          Background

          Anxiety disorders are the most common mental disorders worldwide. In Hong Kong, 7% of adolescents are diagnosed with anxiety disorders, and 1 in every 4 secondary school students reports clinical-level anxiety symptoms. However, 65% of them do not access services. Long waitlists in public services, the high cost of private services, or the fear of being stigmatized can hinder service access. The high prevalence of anxiety and low intervention uptake indicate a pressing need to develop timely, scalable, and potent interventions suitable for adolescents. Single-session interventions (SSIs) have the potential to be scalable interventions for diagnosable or subclinical psychopathology in adolescents. Providing precise and context-adapted intervention is the key to achieving intervention efficacy.

          Objective

          This study aims to compare the effectiveness of three SSIs: single-session intervention of growth mindset on negative emotions (SIGMA), SSI of growth mindset of personality (SSI-GP), and active control, in reducing adolescent anxiety.

          Methods

          Adolescents (N=549, ages 12-16 years) from secondary schools will be randomized to 1 of 3 intervention conditions: the SIGMA, SSI-GP, or active control. The implementation of each intervention is approximately 45 minutes in length. Adolescent participants will report anxiety symptoms (primary outcome), perceived control, hopelessness, attitude toward help-seeking, and psychological well-being at preintervention, the 2-week follow-up, and the 8-week follow-up. A pilot test has confirmed the feasibility and acceptability of SIGMA among adolescents. We hypothesized that SIGMA and SSI-GP will result in a larger reduction in anxiety symptoms than the control intervention during the posttest and 8-week follow-up period. We also predict that SIGMA will have a more significant effect than SSI-GP. We will use the intention-to-treat principle and linear regression-based maximum likelihood multilevel models for data analysis.

          Results

          This study will be conducted from December 2022 to December 2023, with results expected to be available in January 2024.

          Conclusions

          This protocol introduces the implementation content and strategies of growth mindset SSIs (consists of 2 forms: SIGMA and SSI-GP) among school students. The study will provide evidence on the efficacy of different growth mindset SSIs for adolescent anxiety. It will also establish implementation strategies for self-administrative SSIs among school students, which can serve as a pioneer implementation of a scalable and self-accessible brief intervention to improve the well-being of young people.

          Trial Registration

          ClinicalTrials.gov NCT05027880; https://clinicaltrials.gov/ct2/show/NCT05027880

          International Registered Report Identifier (IRRID)

          PRR1-10.2196/41758

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          Most cited references37

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          A brief measure for assessing generalized anxiety disorder: the GAD-7.

          Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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            CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

            The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.
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              Instructional manipulation checks: Detecting satisficing to increase statistical power

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                Author and article information

                Contributors
                Department of Applied Social Sciences , The Hong Kong Polytechnic University , Hong Kong , 852 2766 5787 , jasmine.zhu@polyu.edu.hk
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                2023
                17 March 2023
                : 12
                : e41758
                Affiliations
                [1 ] Department of Applied Social Sciences The Hong Kong Polytechnic University Hong Kong Hong Kong
                [2 ] Department of Social Work and Social Administration The University of Hong Kong Hong Kong Hong Kong
                [3 ] Southampton Clinical Trials Unit University of Southampton Southampton United Kingdom
                [4 ] Department of Social Work Hong Kong Hong Kong
                [5 ] Castle Peak Hospital Hong Kong Hong Kong
                Author notes
                Corresponding Author: Shimin Zhu jasmine.zhu@ 123456polyu.edu.hk
                Author information
                https://orcid.org/0000-0003-3428-0234
                https://orcid.org/0000-0001-9003-1086
                https://orcid.org/0000-0001-8508-9224
                https://orcid.org/0000-0002-5729-6450
                https://orcid.org/0000-0002-6223-5345
                https://orcid.org/0000-0002-2815-7320
                Article
                v12i1e41758
                10.2196/41758
                10131727
                36930199
                e5668257-bdec-48cd-a782-5ed3a1307e1c
                ©Shimin Zhu, Samson Tse, Ko Ling Chan, Paul Lee, Qijin Cheng, Jessica Sun. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 17.03.2023.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 5 December 2022
                : 20 December 2022
                : 26 December 2022
                : 31 December 2022
                Categories
                Protocol
                Protocol
                Custom metadata
                The proposal for this study was peer reviewed by by the Hong Kong Research Grants Council - General Research Fund and Early Career Scheme.

                growth mindset,fixed mindset,mental health,secondary school students, brief intervention, belief-in-change

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