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      Effects of a peer co-facilitated educational programme for parents of children with ADHD: a feasibility randomised controlled trial protocol

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          Abstract

          Introduction

          Significant numbers of children with attention deficit hyperactivity disorder (ADHD) display problems that cause multiple disabilities, deficits and handicaps that interfere with social relationships, development and school achievement. They may have multiple problems, which strain family dynamics and influence the child’s treatment. Parent activation, described as parents’ knowledge, skills and confidence in dealing with their child’s health and healthcare, has been shown to be an important factor in improving health outcomes. Research suggests that parents need edification to learn skills crucial to the treatment and management of their children’s healthcare. Promoting positive parenting techniques may reduce negative parenting factors in families. This study aims to assess the acceptability, feasibility and estimated sample size of a randomised controlled trial (RCT) comparing an ADHD peer co-led educational programme added to treatment as usual (TAU).

          Methods and analysis

          Using a randomised waitlist controlled trial, parents of children aged 6–12 years newly diagnosed with ADHD, and referred to a child mental health outpatient clinic in Mid-Norway, will receive TAU concomitant with a peer co-facilitated parental engagement educational programme (n=25). Parents in the control group will receive TAU, and the educational programme treatment within a waitlist period of 3–6 months (n=25). Parent activation, satisfaction, well-being, quality of life and treatment adherence, will be assessed at baseline (T0), 2 weeks (T1) pre–post intervention (T2, T3) and at 3 months follow-up (T4). Shared decision making, parents preferred role in health-related decisions and involvement, parent-reported symptoms of ADHD and child’s overall level of functioning will be assessed at T0 and T4. Such data will be used to calculate the required sample size for a full-scale RCT.

          Ethics and dissemination

          Approval was obtained from the Regional Committee for Medicine and Health Research Ethics in Mid-Norway (ref: 2018/1196). The findings of this study are expected to provide valuable knowledge about how to optimise family education and management of ADHD and will be disseminated through presentations at conferences and publication in peer-reviewed journals.

          Trial registration number

          NCT04010851.

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          Most cited references69

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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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            SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

            High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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              Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable

              Sample size justification is an important consideration when planning a clinical trial, not only for the main trial but also for any preliminary pilot trial. When the outcome is a continuous variable, the sample size calculation requires an accurate estimate of the standard deviation of the outcome measure. A pilot trial can be used to get an estimate of the standard deviation, which could then be used to anticipate what may be observed in the main trial. However, an important consideration is that pilot trials often estimate the standard deviation parameter imprecisely. This paper looks at how we can choose an external pilot trial sample size in order to minimise the sample size of the overall clinical trial programme, that is, the pilot and the main trial together. We produce a method of calculating the optimal solution to the required pilot trial sample size when the standardised effect size for the main trial is known. However, as it may not be possible to know the standardised effect size to be used prior to the pilot trial, approximate rules are also presented. For a main trial designed with 90% power and two-sided 5% significance, we recommend pilot trial sample sizes per treatment arm of 75, 25, 15 and 10 for standardised effect sizes that are extra small (≤0.1), small (0.2), medium (0.5) or large (0.8), respectively.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2020
                2 December 2020
                : 10
                : 12
                : e039852
                Affiliations
                [1 ]departmentDepartment of Mental Health , Faculty of medicine and health sciences, Norwegian University of Science and Technology (NTNU) , Trondheim, Norway
                [2 ]departmentFaculty of Health and Social Sciences , Molde University College , Molde, Norway
                [3 ]departmentDivision of Psychiatry , Kristiansund Community Mental Health Centre, Møre og Romsdal Hospital Trust , Kristiansund, Norway
                [4 ]departmentDivision of Psychiatry , Nidaros Community Mental Health Centre, St Olav's University Hospital , Trondheim, Norway
                [5 ]departmentDivision of Mid-Norway , Vårres Regional User Involvement Centre , Trondheim, Norway
                [6 ]departmentDepartment of Internal Medicine, Dermatology and Psychiatry , Universidad de La Laguna, San Cristóbal de La Laguna , Tenerife, Spain
                [7 ]departmentInstituto Universitario de Neurociencia (IUNE) , Universidad de La Laguna, San Cristóbal deLa Laguna , Tenerife, Spain
                [8 ]departmentDivision of Psychiatry , Tiller Community Mental Health Centre, St Olav's University Hospital , Trondheim, Norway
                [9 ]departmentDepartment of Research and Development, Division of Mental Health , St Olav’s University Hospital , Trondheim, Norway
                Author notes
                [Correspondence to ] Dr Ingunn Mundal; ingunn.p.mundal@ 123456ntnu.no
                Author information
                http://orcid.org/0000-0001-7716-7122
                Article
                bmjopen-2020-039852
                10.1136/bmjopen-2020-039852
                7713204
                33268416
                f99a8df2-c8c1-48c7-928c-5c2e885a9e53
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 27 April 2020
                : 19 August 2020
                : 02 November 2020
                Categories
                Mental Health
                1506
                1712
                Protocol
                Custom metadata
                unlocked

                Medicine
                quality in health care,developmental neurology & neurodisability,child & adolescent psychiatry

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