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Alcohol AbuseAPSALSNCT02280551

The Australian Parental Supply of Alcohol Longitudinal Study (APSALS)

An observational study of Alcohol Abuse, run by The University of New South Wales at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 11 to 13 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Abuse
How many people
1,927 participants
Where
1 siteAustralia
Study dates
Mar 2010to Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 13 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: 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)).

Who may be able to join

  • Grade 7 High School enrolment
  • Parental signed informed consent provided

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

Australia1 site
  • University of New South Wales

    Sydney, New South Wales, 2052

Other trials in Australia

About this study

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.

Read the detailed description

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?

Background: 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.

Aims: The aims of this study are to determine if:

  1. Parental supply is associated with the progression (acceleration/deceleration) in adolescent drinking over time;
  2. The immediate and broader contextual factors mediate or moderate the relationship between parental supply and progression in adolescent drinking over time.

Design: A longitudinal study across three states in Australia (New South Wales, Tasmania, and Western Australia).

Recruitment: Catholic, Independent and Government school in NSW, Tasmania and Western Australia.

Data 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.

Sample 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.

Conditions
Alcohol Abuse
Keywords
adolescent, alcohol, parent, epidemiology
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02280551
Study groupRoleWhat they receive
Adolescents1927 Grade 7 high school students
ParentA parent of each of the 1927 Grade 7 high school students

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of alcohol consumption

    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.

    Measured: 12 month

  2. Typical quantity of alcohol consumption

    Quantity of alcohol consumption within past 12 months measured as number of standard drinks (an Australian standard drink contains 10g alcohol).

    Measured: 12 month

  3. Frequency of binge drinking

    Frequency of drinking more than 4 standard drinks in the past 12 months

    Measured: 12 month

  4. Experience of alcohol related harms

    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.

    Measured: 12 months

  5. Symptoms of alcohol abuse, dependence and alcohol use disorder

    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).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2014 (estimated)
  2. Study startMar 2010
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,927 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02280551
Sponsor's protocol ID
DP:1096668
Acronym
APSALS
Status last verified
May 2021
First submitted
29 Oct 2014
Last updated
6 May 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25684054
  • 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.

    PubMed 26248081
  • 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.

    PubMed 26921283
  • 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.

    PubMed 27702422
  • 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.

    PubMed 25953785
  • 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.

    PubMed 29160941
  • 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.

    PubMed 29396259
  • 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.

    PubMed 30035831
  • 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.

    PubMed 30851106
  • 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.

    PubMed 31494442
  • 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.

    PubMed 32034841
  • 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.

    PubMed 32141130
  • 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.

    PubMed 32968030
  • 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.

    PubMed 32871506
  • 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.

    PubMed 33464664

Questions about this trial

What is this clinical trial studying?

An observational study of Alcohol Abuse, run by The University of New South Wales at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of alcohol consumption (time frame: 12 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02280551, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.

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