The Australian Parental Supply of Alcohol Longitudinal Study (APSALS)

Alcohol Abuse Clinical Trial

— APSALS  

Official title:

The Australian Parental Supply of Alcohol Longitudinal Study (APSALS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02280551
• Other study ID #: DP:1096668
• Status: Active, not recruiting
• Start date: March 2010
• Est. completion date: December 2021

Study information

• Verified date: May 2021
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1927
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 13 Years

Eligibility

Inclusion Criteria:

• Grade 7 High School enrolment

• Parental signed informed consent provided

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism

Locations

Country	Name	City	State
Australia	University of New South Wales	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

References & Publications (15)

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 asso — View 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):100-11 — View 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. — View 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 pro — View 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 coho — View 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-r — View 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: — View 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: — View 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 coho — View 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 co — View 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. — View 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 — View 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.2015-2 — View 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 — View 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 outcome — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 month
Primary	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).	12 month
Primary	Frequency of binge drinking	Frequency of drinking more than 4 standard drinks in the past 12 months	12 month
Primary	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.	12 months
Primary	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).	12 months

External Links

•   NATIONAL DRUG AND ALCOHOL RESEARCH CENTRE, UNSW, WEBSITE