title: Preventing anxiety problems in children with Cool Little Kids Online: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Anxiety disorders are the most common type of mental health problem and begin early in life. Early intervention to prevent anxiety problems in young children who are at risk has the potential for long-term impact. The 'Cool Little Kids' parenting group program was previously established to prevent anxiety disorders in young children at risk because of inhibited temperament. This group program was efficacious in two randomised controlled trials and has recently been adapted into an online format. 'Cool Little Kids Online' was developed to widen and facilitate access to the group program's preventive content. A pilot evaluation of the online program demonstrated its perceived utility and acceptability among parents. This study aims to evaluate the efficacy of Cool Little Kids Online in a large randomised controlled trial.
  
  
  METHODS
  Parents of young children who are 3-6 years old and who have an inhibited temperament will be recruited (n = 385) and randomly assigned to either immediate access to Cool Little Kids Online or delayed access after a waiting period of 24 weeks. The online program contains eight modules that help parents address key issues in the development of anxiety problems in inhibited children, including children's avoidant coping styles, overprotective parenting behaviours, and parents' own fears and worries. Intervention participants will be offered clinician support when requested. The primary outcome will be change in parent-reported child anxiety symptoms. Secondary outcomes will be child internalising symptoms, child and family life interference due to anxiety, over-involved/protective parenting, plus child anxiety diagnoses assessed by using a new online diagnostic tool. Assessments will take place at baseline and 12 and 24 weeks after baseline.
  
  
  CONCLUSIONS
  This trial expands upon previous research on the Cool Little Kids parenting group program and will evaluate the efficacy of online delivery. Online delivery of the program could result in an easily accessible evidence-based resource to help families with young children at temperamental risk for anxiety disorders.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry 12615000217505 (registered 5 March 2015).
authors.affiliation: School of Psychology and Public Health, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086, Australia. amy.morgan@latrobe.edu.au.
authors.forename: Amy J
authors.initials: AJ
authors.lastname: Morgan
authors.affiliation: Centre for Emotional Health, Building C3A, Level 7, Macquarie University, Sydney, NSW, 2109, Australia. ron.rapee@mq.edu.au.
authors.forename: Ronald M
authors.initials: RM
authors.lastname: Rapee
authors.affiliation: School of Psychology and Public Health, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086, Australia. 17859092@students.latrobe.edu.au.
authors.forename: Elli
authors.initials: E
authors.lastname: Tamir
authors.affiliation: School of Psychology and Public Health, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086, Australia. n.goharpey@latrobe.edu.au.
authors.forename: Nahal
authors.initials: N
authors.lastname: Goharpey
authors.affiliation: Department of Mathematics and Statistics, School of Engineering and Mathematical Sciences, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086, Australia. a.salim@latrobe.edu.au.
authors.forename: Agus
authors.initials: A
authors.lastname: Salim
authors.affiliation: Centre for Emotional Health, Building C3A, Level 7, Macquarie University, Sydney, NSW, 2109, Australia. lauren.mclellan@mq.edu.au.
authors.forename: Lauren F
authors.initials: LF
authors.lastname: McLellan
authors.affiliation: School of Psychology and Public Health, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086, Australia. j.bayer@latrobe.edu.au.|Murdoch Childrens Research Institute, Royal Children's Hospital, Flemington Road, Parkville, Victoria, 3052, Australia. j.bayer@latrobe.edu.au.|Department of Paediatrics, University of Melbourne, Royal Children's Hospital, Flemington Road, Parkville, Victoria, 3010, Australia. j.bayer@latrobe.edu.au.
authors.forename: Jordana K
authors.initials: JK
authors.lastname: Bayer
mesh_terms: D000223:Adaptation, Psychological; D000367:Age Factors; D001008:Anxiety Disorders / Q000175:diagnosis / Q000517:prevention & control* / Q000523:psychology; D001315:Australia; D002648:Child; D002652:Child Behavior; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007266:Inhibition, Psychological; D020407:Internet; D008297:Male; D010287:Parent-Child Relations; D016487:Parenting; D010290:Parents / Q000523:psychology; D015397:Program Evaluation; D012107:Research Design; D013813:Therapy, Computer-Assisted / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome