Development of a multicentre randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people in a high-school setting (SIPS JR-HIGH)

Emma Giles, Stephanie Scott, Simon Coulton, Paolo Deluca, Colin Drummond, Erin Graybill, Denise Howel, Eileen Kaner, Elaine McColl, Ruth McGovern, Elaine Stamp, Harry Sumnall, Les Tate, Liz Todd, Dorothy Newbury-Birch

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Abstract

Background: Young people are vulnerable to the effects of alcohol consumption. Adverse impacts from alcohol manifest in a range of short and long term physical and psycho-social factors, including neurological issues, cognitive impairment, and risk-taking behaviours. The aim of the multi-centre SIPS JR-HIGH individual-randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of alcohol screening and brief intervention to reduce risky drinking in young people aged 14-15 in the English high school setting.
Methods: Building on the mixed method cluster randomised controlled pilot feasibility trial (10/3002/07), the proposed sample for the definitive trial, to be conducted from September 2015 until December 2017, has been calculated to have a 90% power and will follow-up 257 young people in each arm at 12 month follow up. To recruit this sample, twenty schools will be recruited (September 2015), with five schools recruited from North East England, the North West, London and Kent. The individually randomised two armed RCT will incorporate a control arm of usual school-based practice on alcohol issues and an intervention arm which combines usual care with a 30 minute brief intervention delivered by school learning mentors. Individual pupils will be randomised to one of the two arms. Descriptive statistical analysis will be used to report the pupil-level baseline data, with multiple linear regressions being used to compare the primary outcomes between the two arms at 12 months.
Findings: The pilot trial guided the development of the manualised intervention, which includes process information and a 30-minute personalised interactive worksheet-based session delivered by learning mentors. The pilot suggested that this intervention was acceptable, however an intervention with parental involvement was not found to be feasible, with parents not engaging with the research.
Interpretation: Limited evidence exists in a UK context to explore screening and brief intervention to reduce risky drinking in young adolescents. The pilot trial has informed the design of the upcoming definitive trial which, if the intervention is effective, will facilitate the development of manualised screening and brief intervention to be adopted in routine school practice in high schools in England.
Original languageEnglish
JournalThe Lancet
Volume386
Issue number2
DOIs
Publication statusPublished - 2015

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Drinking
Randomized Controlled Trials
Alcohols
Arm
Mentors
Pupil
England
Learning
Risk-Taking
Alcohol Drinking
Cost-Benefit Analysis
Linear Models
Parents
Research

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Giles, Emma ; Scott, Stephanie ; Coulton, Simon ; Deluca, Paolo ; Drummond, Colin ; Graybill, Erin ; Howel, Denise ; Kaner, Eileen ; McColl, Elaine ; McGovern, Ruth ; Stamp, Elaine ; Sumnall, Harry ; Tate, Les ; Todd, Liz ; Newbury-Birch, Dorothy. / Development of a multicentre randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people in a high-school setting (SIPS JR-HIGH). In: The Lancet. 2015 ; Vol. 386, No. 2.
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abstract = "Background: Young people are vulnerable to the effects of alcohol consumption. Adverse impacts from alcohol manifest in a range of short and long term physical and psycho-social factors, including neurological issues, cognitive impairment, and risk-taking behaviours. The aim of the multi-centre SIPS JR-HIGH individual-randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of alcohol screening and brief intervention to reduce risky drinking in young people aged 14-15 in the English high school setting.Methods: Building on the mixed method cluster randomised controlled pilot feasibility trial (10/3002/07), the proposed sample for the definitive trial, to be conducted from September 2015 until December 2017, has been calculated to have a 90{\%} power and will follow-up 257 young people in each arm at 12 month follow up. To recruit this sample, twenty schools will be recruited (September 2015), with five schools recruited from North East England, the North West, London and Kent. The individually randomised two armed RCT will incorporate a control arm of usual school-based practice on alcohol issues and an intervention arm which combines usual care with a 30 minute brief intervention delivered by school learning mentors. Individual pupils will be randomised to one of the two arms. Descriptive statistical analysis will be used to report the pupil-level baseline data, with multiple linear regressions being used to compare the primary outcomes between the two arms at 12 months.Findings: The pilot trial guided the development of the manualised intervention, which includes process information and a 30-minute personalised interactive worksheet-based session delivered by learning mentors. The pilot suggested that this intervention was acceptable, however an intervention with parental involvement was not found to be feasible, with parents not engaging with the research.Interpretation: Limited evidence exists in a UK context to explore screening and brief intervention to reduce risky drinking in young adolescents. The pilot trial has informed the design of the upcoming definitive trial which, if the intervention is effective, will facilitate the development of manualised screening and brief intervention to be adopted in routine school practice in high schools in England.",
author = "Emma Giles and Stephanie Scott and Simon Coulton and Paolo Deluca and Colin Drummond and Erin Graybill and Denise Howel and Eileen Kaner and Elaine McColl and Ruth McGovern and Elaine Stamp and Harry Sumnall and Les Tate and Liz Todd and Dorothy Newbury-Birch",
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Development of a multicentre randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people in a high-school setting (SIPS JR-HIGH). / Giles, Emma; Scott, Stephanie; Coulton, Simon; Deluca, Paolo; Drummond, Colin; Graybill, Erin; Howel, Denise; Kaner, Eileen; McColl, Elaine; McGovern, Ruth; Stamp, Elaine; Sumnall, Harry; Tate, Les; Todd, Liz; Newbury-Birch, Dorothy.

In: The Lancet, Vol. 386, No. 2, 2015.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Development of a multicentre randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people in a high-school setting (SIPS JR-HIGH)

AU - Giles, Emma

AU - Scott, Stephanie

AU - Coulton, Simon

AU - Deluca, Paolo

AU - Drummond, Colin

AU - Graybill, Erin

AU - Howel, Denise

AU - Kaner, Eileen

AU - McColl, Elaine

AU - McGovern, Ruth

AU - Stamp, Elaine

AU - Sumnall, Harry

AU - Tate, Les

AU - Todd, Liz

AU - Newbury-Birch, Dorothy

PY - 2015

Y1 - 2015

N2 - Background: Young people are vulnerable to the effects of alcohol consumption. Adverse impacts from alcohol manifest in a range of short and long term physical and psycho-social factors, including neurological issues, cognitive impairment, and risk-taking behaviours. The aim of the multi-centre SIPS JR-HIGH individual-randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of alcohol screening and brief intervention to reduce risky drinking in young people aged 14-15 in the English high school setting.Methods: Building on the mixed method cluster randomised controlled pilot feasibility trial (10/3002/07), the proposed sample for the definitive trial, to be conducted from September 2015 until December 2017, has been calculated to have a 90% power and will follow-up 257 young people in each arm at 12 month follow up. To recruit this sample, twenty schools will be recruited (September 2015), with five schools recruited from North East England, the North West, London and Kent. The individually randomised two armed RCT will incorporate a control arm of usual school-based practice on alcohol issues and an intervention arm which combines usual care with a 30 minute brief intervention delivered by school learning mentors. Individual pupils will be randomised to one of the two arms. Descriptive statistical analysis will be used to report the pupil-level baseline data, with multiple linear regressions being used to compare the primary outcomes between the two arms at 12 months.Findings: The pilot trial guided the development of the manualised intervention, which includes process information and a 30-minute personalised interactive worksheet-based session delivered by learning mentors. The pilot suggested that this intervention was acceptable, however an intervention with parental involvement was not found to be feasible, with parents not engaging with the research.Interpretation: Limited evidence exists in a UK context to explore screening and brief intervention to reduce risky drinking in young adolescents. The pilot trial has informed the design of the upcoming definitive trial which, if the intervention is effective, will facilitate the development of manualised screening and brief intervention to be adopted in routine school practice in high schools in England.

AB - Background: Young people are vulnerable to the effects of alcohol consumption. Adverse impacts from alcohol manifest in a range of short and long term physical and psycho-social factors, including neurological issues, cognitive impairment, and risk-taking behaviours. The aim of the multi-centre SIPS JR-HIGH individual-randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of alcohol screening and brief intervention to reduce risky drinking in young people aged 14-15 in the English high school setting.Methods: Building on the mixed method cluster randomised controlled pilot feasibility trial (10/3002/07), the proposed sample for the definitive trial, to be conducted from September 2015 until December 2017, has been calculated to have a 90% power and will follow-up 257 young people in each arm at 12 month follow up. To recruit this sample, twenty schools will be recruited (September 2015), with five schools recruited from North East England, the North West, London and Kent. The individually randomised two armed RCT will incorporate a control arm of usual school-based practice on alcohol issues and an intervention arm which combines usual care with a 30 minute brief intervention delivered by school learning mentors. Individual pupils will be randomised to one of the two arms. Descriptive statistical analysis will be used to report the pupil-level baseline data, with multiple linear regressions being used to compare the primary outcomes between the two arms at 12 months.Findings: The pilot trial guided the development of the manualised intervention, which includes process information and a 30-minute personalised interactive worksheet-based session delivered by learning mentors. The pilot suggested that this intervention was acceptable, however an intervention with parental involvement was not found to be feasible, with parents not engaging with the research.Interpretation: Limited evidence exists in a UK context to explore screening and brief intervention to reduce risky drinking in young adolescents. The pilot trial has informed the design of the upcoming definitive trial which, if the intervention is effective, will facilitate the development of manualised screening and brief intervention to be adopted in routine school practice in high schools in England.

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DO - 10.1016/S0140-6736(15)00875-2

M3 - Article

VL - 386

JO - The Lancet

JF - The Lancet

SN - 0140-6736

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