Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-20 @ 3:32 PM
Study NCT ID:
NCT02280551
Status:
UNKNOWN
Last Update Posted:
2021-05-06
First Post:
2014-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Australian Parental Supply of Alcohol Longitudinal Study (APSALS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1927}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-02', 'studyFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2014-10-30', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of alcohol consumption', 'timeFrame': '12 month', 'description': 'Frequency of alcohol consumption within past 12 months, categorized as: none, 1 day/month, 2-3 days/month, 1 day/week, 2 days/week, 3 days/week, 4 days/week, 5 days/week, 6 days/week, every day.'}, {'measure': 'Typical quantity of alcohol consumption', 'timeFrame': '12 month', 'description': 'Quantity of alcohol consumption within past 12 months measured as number of standard drinks (an Australian standard drink contains 10g alcohol).'}, {'measure': 'Frequency of binge drinking', 'timeFrame': '12 month', 'description': 'Frequency of drinking more than 4 standard drinks in the past 12 months'}, {'measure': 'Experience of alcohol related harms', 'timeFrame': '12 months', 'description': '17 item scale of alcohol related harms, adapted from the School Health and Alcohol Harm Reduction Project. Scores range from 0 to 85, with higher scores indicating greater experience of harms.'}, {'measure': 'Symptoms of alcohol abuse, dependence and alcohol use disorder', 'timeFrame': '12 months', 'description': 'Symptoms of alcohol abuse, dependence, and alcohol use disorder measured via the Diagnostic Interview Schedule for Children 4th Edition. Items correspond to Diagnostic and Statistical Manual of Mental Disorders 4th Edition symptoms of alcohol abuse (4 symptoms), dependence (7 symptoms), and alcohol use disorder (11 symptoms).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adolescent', 'alcohol', 'parent', 'epidemiology'], 'conditions': ['Alcohol Abuse']}, 'referencesModule': {'references': [{'pmid': '25684054', 'type': 'RESULT', 'citation': 'Wadolowski M, Bruno R, Aiken A, Stone C, Najman J, Kypri K, Slade T, Hutchinson D, McBride N, Mattick RP. Sipping, drinking, and early adolescent alcohol consumption: a cautionary note. Alcohol Clin Exp Res. 2015 Feb;39(2):350-4. doi: 10.1111/acer.12613.'}, {'pmid': '26248081', 'type': 'RESULT', 'citation': 'Wadolowski M, Hutchinson D, Bruno R, Aiken A, Clare P, Slade T, Najman J, Kypri K, McBride N, Mattick RP. Early Adolescent Alcohol Use: Are Sipping and Drinking Distinct? Alcohol Clin Exp Res. 2015 Sep;39(9):1805-13. doi: 10.1111/acer.12826. Epub 2015 Aug 6.'}, {'pmid': '26921283', 'type': 'RESULT', 'citation': 'Wadolowski M, Hutchinson D, Bruno R, Aiken A, Najman JM, Kypri K, Slade T, McBride N, Mattick RP. Parents Who Supply Sips of Alcohol in Early Adolescence: A Prospective Study of Risk Factors. Pediatrics. 2016 Mar;137(3):e20152611. doi: 10.1542/peds.2015-2611. Epub 2016 Feb 26.'}, {'pmid': '27702422', 'type': 'RESULT', 'citation': 'Mattick RP, Wadolowski M, Aiken A, Clare PJ, Hutchinson D, Najman J, Slade T, Bruno R, McBride N, Degenhardt L, Kypri K. Parental supply of alcohol and alcohol consumption in adolescence: prospective cohort study. Psychol Med. 2017 Jan;47(2):267-278. doi: 10.1017/S0033291716002373. Epub 2016 Oct 5.'}, {'pmid': '25953785', 'type': 'RESULT', 'citation': 'Aiken A, Wadolowski M, Bruno R, Najman J, Kypri K, Slade T, Hutchinson D, McBride N, Mattick RP. Cohort Profile: The Australian Parental Supply of Alcohol Longitudinal Study (APSALS). Int J Epidemiol. 2017 Apr 1;46(2):e6. doi: 10.1093/ije/dyv051.'}, {'pmid': '29160941', 'type': 'RESULT', 'citation': 'Aiken A, Clare PJ, Wadolowski M, Hutchinson D, Najman JM, Slade T, Bruno R, McBride N, Kypri K, Mattick RP. Age of Alcohol Initiation and Progression to Binge Drinking in Adolescence: A Prospective Cohort Study. Alcohol Clin Exp Res. 2018 Jan;42(1):100-110. doi: 10.1111/acer.13525. Epub 2017 Nov 21.'}, {'pmid': '29396259', 'type': 'RESULT', 'citation': 'Mattick RP, Clare PJ, Aiken A, Wadolowski M, Hutchinson D, Najman J, Slade T, Bruno R, McBride N, Kypri K, Vogl L, Degenhardt L. Association of parental supply of alcohol with adolescent drinking, alcohol-related harms, and alcohol use disorder symptoms: a prospective cohort study. Lancet Public Health. 2018 Feb;3(2):e64-e71. doi: 10.1016/S2468-2667(17)30240-2. Epub 2018 Feb 1.'}, {'pmid': '30035831', 'type': 'RESULT', 'citation': 'Sharmin S, Kypri K, Wadolowski M, Bruno R, Khanam M, Aiken A, Hutchinson D, M Najman J, Slade T, McBride N, Attia J, P Mattick R. Parent characteristics associated with approval of their children drinking alcohol from ages 13 to 16 years: prospective cohort study. Aust N Z J Public Health. 2018 Aug;42(4):347-353. doi: 10.1111/1753-6405.12811. Epub 2018 Jul 23.'}, {'pmid': '30851106', 'type': 'RESULT', 'citation': "Sharmin S, Kypri K, Wadolowski M, Bruno R, Khanam M, Aiken A, Hutchinson D, Najman JM, Slade T, McBride N, Attia J, Palazzi K, Oldmeadow C, Mattick RP. Parent hazardous drinking and their children's alcohol use in early and mid-adolescence: prospective cohort study. Eur J Public Health. 2019 Aug 1;29(4):736-740. doi: 10.1093/eurpub/ckz029."}, {'pmid': '31494442', 'type': 'RESULT', 'citation': 'Clare PJ, Aiken A, Yuen WS, Peacock A, Boland V, Wadolowski M, Hutchinson D, Najman J, Slade T, Bruno R, McBride N, Degenhardt L, Kypri K, Mattick RP. Parental supply of alcohol as a predictor of adolescent alcohol consumption patterns: A prospective cohort. Drug Alcohol Depend. 2019 Nov 1;204:107529. doi: 10.1016/j.drugalcdep.2019.06.031. Epub 2019 Aug 29.'}, {'pmid': '32034841', 'type': 'RESULT', 'citation': 'Clare PJ, Dobbins T, Bruno R, Peacock A, Boland V, Yuen WS, Aiken A, Degenhardt L, Kypri K, Slade T, Hutchinson D, Najman JM, McBride N, Horwood J, McCambridge J, Mattick RP. The overall effect of parental supply of alcohol across adolescence on alcohol-related harms in early adulthood-a prospective cohort study. Addiction. 2020 Oct;115(10):1833-1843. doi: 10.1111/add.15005. Epub 2020 Mar 6.'}, {'pmid': '32141130', 'type': 'RESULT', 'citation': 'Boland VC, Clare PJ, Yuen WS, Peacock A, Aiken A, Wadolowski M, Hutchinson D, Najman J, Slade T, Bruno R, McBride N, Degenhardt L, Kypri K, Mattick RP. The association between parental supply of alcohol and supply from other sources to young people: a prospective cohort. Addiction. 2020 Nov;115(11):2140-2147. doi: 10.1111/add.15033. Epub 2020 Mar 24.'}, {'pmid': '32968030', 'type': 'RESULT', 'citation': 'Yuen WS, Chan G, Bruno R, Clare P, Mattick R, Aiken A, Boland V, McBride N, McCambridge J, Slade T, Kypri K, Horwood J, Hutchinson D, Najman J, De Torres C, Peacock A. Adolescent Alcohol Use Trajectories: Risk Factors and Adult Outcomes. Pediatrics. 2020 Oct;146(4):e20200440. doi: 10.1542/peds.2020-0440. Epub 2020 Sep 23.'}, {'pmid': '32871506', 'type': 'RESULT', 'citation': 'Aiken A, Clare PJ, Boland VC, Degenhardt L, Yuen WS, Hutchinson D, Najman J, McCambridge J, Slade T, McBride N, De Torres C, Wadolowski M, Bruno R, Kypri K, Mattick RP, Peacock A. Parental supply of sips and whole drinks of alcohol to adolescents and associations with binge drinking and alcohol-related harms: A prospective cohort study. Drug Alcohol Depend. 2020 Oct 1;215:108204. doi: 10.1016/j.drugalcdep.2020.108204. Epub 2020 Aug 5.'}, {'pmid': '33464664', 'type': 'RESULT', 'citation': 'Yuen WS, Chan G, Bruno R, Clare PJ, Aiken A, Mattick R, Farrell M, Kypri K, Slade T, Hutchinson D, McBride N, McCambridge J, Boland V, Peacock A. Trajectories of alcohol-induced blackouts in adolescence: early risk factors and alcohol use disorder outcomes in early adulthood. Addiction. 2021 Aug;116(8):2039-2048. doi: 10.1111/add.15415. Epub 2021 Feb 1.'}, {'pmid': '35752023', 'type': 'DERIVED', 'citation': 'Aiken A, Chan G, Yuen WS, Clare PJ, Hutchinson D, McBride N, Najman JM, McCambridge J, Upton E, Slade T, Boland VC, De Torres C, Bruno R, Kypri K, Wadolowski M, Mattick RP, Peacock A. Trajectories of parental and peer supply of alcohol in adolescence and associations with later alcohol consumption and harms: A prospective cohort study. Drug Alcohol Depend. 2022 Aug 1;237:109533. doi: 10.1016/j.drugalcdep.2022.109533. Epub 2022 Jun 11.'}, {'pmid': '34383569', 'type': 'DERIVED', 'citation': 'Najman JM, Clare PJ, Kypri K, Aiken A, Wadolowski M, Hutchinson D, Slade T, Bruno R, Vogl L, Degenhardt L, Mattick RP. Gender differences in the supply of alcohol to adolescent daughters and sons. Am J Drug Alcohol Abuse. 2021 Jul 4;47(4):508-520. doi: 10.1080/00952990.2021.1927066. Epub 2021 Aug 12.'}], 'seeAlsoLinks': [{'url': 'http://ndarc.med.unsw.edu.au/project/can-parents-teach-their-children-drink-alcohol-responsibly-or-one-drop-drop-too-many', 'label': 'NATIONAL DRUG AND ALCOHOL RESEARCH CENTRE, UNSW, WEBSITE'}]}, 'descriptionModule': {'briefSummary': "Parents can positively influence their children's alcohol use. One strategy they use is to provide their children with alcohol, believing it is the best way to teach their children how to drink responsibly. The impact of parental supply is not well understood and may be unintentionally harmful. This study will research the consequences of parental supply within the broader context of parent, child and peer relationships. It will help to determine how parental supply influences the different patterns of adolescent alcohol consumption over time, providing essential information to help parents prevent alcohol misuse in their children. Parents can play a pivotal role in prevention of alcohol misuse, but at present we don't know exactly how.", 'detailedDescription': 'Title: The Australian Parental Supply of Alcohol Longitudinal Study (APSALS): Can parents teach their children to drink alcohol responsibly? Or, is one drop a drop too many?\n\nBackground: The Australian Parental Supply of Alcohol Longitudinal Study (APSALS) was established to investigate the short- and long-term associations between exposure to parental alcohol provision, early adolescent alcohol initiation, subsequent alcohol use, and alcohol-related harms, controlling for a wide range of parental, child, familial, peer, and contextual covariates. The cohort commenced with 1927 parent-child dyads comprised of Australian Grade 7 school students, and a parent/guardian. Baseline, one- and two-year follow-up data have been collected, and a three-year follow-up is underway. The data collected include child, familial, parental, and peer factors addressing demographics, alcohol use and supply, parenting practices, other substance use, adolescent behaviours, and peer influences. Baseline data show that only 5.8% of the Grade 7 adolescents had initiated alcohol consumption (of a whole serve of alcohol). Thus, the cohort is ideal for prospectively examining predictors of initiation and progression of alcohol use, which increases markedly through adolescence. Results to date have highlighted the importance of distinguishing between sipping and drinking of full serves of alcohol in the measurement of adolescent alcohol use as these represent distinct behaviours which occur in different environments.\n\nAims: The aims of this study are to determine if:\n\n1. Parental supply is associated with the progression (acceleration/deceleration) in adolescent drinking over time;\n2. The immediate and broader contextual factors mediate or moderate the relationship between parental supply and progression in adolescent drinking over time.\n\nDesign: A longitudinal study across three states in Australia (New South Wales, Tasmania, and Western Australia).\n\nRecruitment: Catholic, Independent and Government school in NSW, Tasmania and Western Australia.\n\nData analysis: Logistic and binomial regression, and multi-level modelling will be used, and latent growth curve modelling (LGCM) within the framework of structural equations modelling (SEM). Moderating and mediating variables, both time variant (e.g., association with alcohol using peers) and time-invariant (e.g. gender) will be modelled. Outcome variables will be modelled using appropriate parametric distributions - Poisson distributions for count data outcomes and binomial distributions for categorical data outcomes. All analyses will be conducted in MPlus v5.2 or Stata. As recommended by Graham imputation of missing data will be done.\n\nSample size calculations: Due to the flexibility of the modelling approach taken (i.e., the number of parameters allowed to vary), there are a number of different scenarios that can be tested to determine an adequate sample size. The primary interest is in differences in drinking over time between groups who were supplied or not supplied alcohol. Thus, regression analysis will address drinking on a dummy-coded "parental supply" variable. It is hypothesised that parental supply of alcohol would alter the trajectory of harmful drinking by a regression coefficient of ±0.2. This regression coefficient is equivalent to a medium effect size difference between groups, a result which is not unexpected given past research. It was assumed that attrition would result in around 20% missing data on each subsequent measurement occasion. Based on simulation studies, and factoring in potential mediators and moderators, 600 children are required at a minimum. However, as small cell sizes for some associations may affect power, a final sample of \\~1800 children and parents has been recruited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The cohort includes 1927 Australian adolescents born from 1996-1999 (mean age at baseline: 12.9 years), and a parent or guardian (typically the mother (in 86.3% of dyads; mean age at baseline: 43.9 years)).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Grade 7 High School enrolment\n* Parental signed informed consent provided\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02280551', 'acronym': 'APSALS', 'briefTitle': 'The Australian Parental Supply of Alcohol Longitudinal Study (APSALS)', 'organization': {'class': 'OTHER', 'fullName': 'The University of New South Wales'}, 'officialTitle': 'The Australian Parental Supply of Alcohol Longitudinal Study (APSALS)', 'orgStudyIdInfo': {'id': 'DP:1096668'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adolescents', 'description': '1927 Grade 7 high school students'}, {'label': 'Parent', 'description': 'A parent of each of the 1927 Grade 7 high school students'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2052', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'University of New South Wales', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'RICHARD P MATTICK, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NATIONAL DRUG AND ALCOHOL RESEARCH CENTRE, UNSW AUSTRALIA'}, {'name': 'AMY PEACOCK, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NATIONAL DRUG AND ALCOHOL RESEARCH CENTRE, UNSW AUSTRALIA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of New South Wales', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Richard P Mattick', 'investigatorFullName': 'Professor Richard P Mattick', 'investigatorAffiliation': 'The University of New South Wales'}}}}