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      Randomized controlled trial to test the efficacy of a brief, communication-based, substance use preventive intervention for parents of adolescents: Protocol for the SUPPER Project (Substance Use Prevention Promoted by Eating family meals Regularly)

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          Abstract

          Background

          Substance use among adolescents in the U.S. is associated with adverse physical and mental health outcomes in the long-term. Universal youth-focused substance use prevention programs have demonstrated effectiveness but are often not sustainable due to the significant amount of time, effort, and resources required. We describe a trial protocol for a brief, low-participant-burden intervention to improve substance use-specific parent-child communication through the promotion of family meals and increased parental engagement.

          Methods

          This study is a parallel-group randomized controlled trial designed to assess the efficacy of a 13-week intervention. A total of 500 dyads of parents and their 5 th-7 th grade children are recruited from across Massachusetts. Dyads are randomized to the intervention or attention-control condition using block urn randomization, based on child grade, gender, and school. Parents/guardians in the substance use preventive intervention arm receive a short handbook, attend two meetings with an interventionist, and receive two SMS messages per week. Parents/guardians in the control arm receive the same dose but with content focused on nutrition, physical activity, and weight stigma. Participant dyads submit videos of family meals, audio recordings of prompted conversations, and quantitative surveys over an 18-month period (baseline, 3, 6, 12, 18 months post-intervention). The primary outcomes measure the quantity and quality of parent-child substance use conversations and proximal child indicators (i.e., substance use attitudes and expectancies, affiliation with substance-using peers, and intentions and willingness to use substances). The secondary outcome is child substance use initiation.

          Discussion

          This is a novel, brief, communication-focused intervention for parents/guardians that was designed to reduce participant burden. The intervention has the potential to improve parent-child engagement and communication and conversations about substance use specifically and decrease child substance use risk factors and substance use initiation.

          Trial registration

          ClinicalTrials.gov NCT03925220. Registered on 24 April 2019.

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          Most cited references52

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          Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

          Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
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            The REDCap consortium: Building an international community of software platform partners

            The Research Electronic Data Capture (REDCap) data management platform was developed in 2004 to address an institutional need at Vanderbilt University, then shared with a limited number of adopting sites beginning in 2006. Given bi-directional benefit in early sharing experiments, we created a broader consortium sharing and support model for any academic, non-profit, or government partner wishing to adopt the software. Our sharing framework and consortium-based support model have evolved over time along with the size of the consortium (currently more than 3200 REDCap partners across 128 countries). While the "REDCap Consortium" model represents only one example of how to build and disseminate a software platform, lessons learned from our approach may assist other research institutions seeking to build and disseminate innovative technologies.
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              Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption-II

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                Author and article information

                Contributors
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Project administrationRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: MethodologyRole: Project administrationRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: MethodologyRole: Project administrationRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: MethodologyRole: Project administrationRole: SupervisionRole: ValidationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS One
                plos
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                2 February 2022
                2022
                : 17
                : 2
                : e0263016
                Affiliations
                [1 ] Tufts University School of Medicine, Boston, MA, United States of America
                [2 ] Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA, United States of America
                [3 ] Warren Alpert Medical School of Brown University, Providence, RI, United States of America
                PLOS: Public Library of Science, UNITED KINGDOM
                Author notes

                Competing Interests: The authors declare that they do not have any competing interests.

                Author information
                https://orcid.org/0000-0002-8047-1018
                https://orcid.org/0000-0001-8531-7602
                https://orcid.org/0000-0001-7151-287X
                https://orcid.org/0000-0002-3991-7014
                Article
                PONE-D-21-23964
                10.1371/journal.pone.0263016
                8809599
                35108294
                5f8b6db8-537b-4d22-8eb3-9a924d5ba065
                © 2022 Skeer et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 26 July 2021
                : 3 December 2021
                Page count
                Figures: 1, Tables: 1, Pages: 18
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/100000009, foundation for the national institutes of health;
                Award ID: 1R01DA045073-01A1
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000009, foundation for the national institutes of health;
                Award ID: R01DA045073-02S1
                Award Recipient :
                MS, ME, and AS received a grant funded by a grant from the National Institutes of Health, National Institute on Drug Abuse (1R01DA045073-01A1), along with a Diversity Supplement (R01DA045073-02S1). https://www.drugabuse.gov/ The funding body had no role in the study design or in writing and preparation of the manuscript. Trial sponsor and supervision information Trial Sponsor: Tufts University School of Medicine Contact Name: Margie Skeer Address: 136 Harrison Ave, Boston, MA 02111, USA Telephone: 617-636-2441 Email: Margie.Skeer@ 123456tufts.edu .
                Categories
                Study Protocol
                Social Sciences
                Sociology
                Education
                Schools
                Research and Analysis Methods
                Research Design
                Survey Research
                Surveys
                People and Places
                Population Groupings
                Age Groups
                Children
                Adolescents
                People and Places
                Population Groupings
                Families
                Children
                Adolescents
                Medicine and Health Sciences
                Pharmacology
                Behavioral Pharmacology
                Recreational Drug Use
                Cannabis
                Marijuana
                Social Sciences
                Sociology
                Human Families
                Biology and Life Sciences
                Psychology
                Behavior
                Verbal Behavior
                Verbal Communication
                Social Sciences
                Psychology
                Behavior
                Verbal Behavior
                Verbal Communication
                Medicine and Health Sciences
                Epidemiology
                Medical Risk Factors
                Biology and Life Sciences
                Nutrition
                Diet
                Alcohol Consumption
                Medicine and Health Sciences
                Nutrition
                Diet
                Alcohol Consumption

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