title: Prem Baby Triple P: a randomised controlled trial of enhanced parenting capacity to improve developmental outcomes in preterm infants.
abstract: BACKGROUND
  Very preterm birth (<32 weeks gestation) is associated with motor, cognitive, behavioural and educational problems in children and maternal depression and withdrawal. Early interventions that target parenting have the greatest potential to create sustained effects on child development and parental psychopathology. Triple P (Positive Parenting Program) has shown positive effects on child behaviour and adjustment, parenting practices and family functioning. Baby Triple P for Preterm infants, has been developed to target parents of very preterm infants. This study tests the effectiveness of Baby Triple P for Preterm infants in improving child and parent/couple outcomes at 24 months corrected age (CA).
  
  
  METHODS
  Families will be randomised to receive either Baby Triple P for Preterm infants or Care as Usual (CAU). Baby Triple P for Preterm infants involves 4 × 2 hr group sessions at the hospital plus 4 × 30 min telephone consultations soon after transfer (42 weeks C.A.). After discharge participants will be linked to community based Triple P and intervention maintenance up to 24 months C.A. Assessments will be: baseline, post-intervention (6 weeks C.A.), at 12 and 24 months C.A. The primary outcome measure is the Infant Toddler Social & Emotional Assessment (ITSEA) at 24 months C.A. Child behavioural and emotional problems will be coded using the mother-toddler version of the Family Observation Schedule at 24 months C.A. Secondary outcome will be the Bayley Scales of Infant and Toddler Development (BSID III) cognitive development, language and motor abilities. Proximal targets of parenting style, parental self-efficacy, parental mental health, parental adjustment, parent-infant attachment, couple relationship satisfaction and couple communication will also be assessed. Our sample size based on the ITSEA, has 80% power, predicted effect size of 0.33 and an 85% retention rate, requires 165 families are required in each group (total sample of 330 families).
  
  
  CONCLUSIONS
  This protocol presents the study design, methods and intervention to be analysed in a randomised trial of Baby Triple P for Preterm infants compared to Care as Usual (CAU) for families of very preterm infants. Publications of all outcomes will be published in peer reviewed journals according to CONSORT guidelines.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry: ACTRN12612000194864.
authors.affiliation: The University of Queensland Centre for Clinical Research, Faculty of Health Sciences, The University of Queensland, Royal Brisbane and Women's Hospital, Brisbane, Australia. p.colditz@uq.edu.au.|Royal Brisbane and Women's Hospital, Brisbane, Australia. p.colditz@uq.edu.au.
authors.forename: Paul
authors.initials: P
authors.lastname: Colditz
authors.affiliation: The Parenting and Family Support Centre, School of Psychology, Faculty of Social and Behavioural Sciences, The University of Queensland, Brisbane, Australia. matts@psy.uq.edu.au.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Sanders
authors.affiliation: Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, Faculty of Health Sciences, The University of Queensland, Brisbane, Australia. r.boyd@uq.edu.au.
authors.forename: Roslyn
authors.initials: R
authors.lastname: Boyd
authors.affiliation: The University of Queensland Centre for Clinical Research, Faculty of Health Sciences, The University of Queensland, Royal Brisbane and Women's Hospital, Brisbane, Australia. m.pritchard@uq.edu.au.|Royal Brisbane and Women's Hospital, Brisbane, Australia. m.pritchard@uq.edu.au.
authors.forename: Margo
authors.initials: M
authors.lastname: Pritchard
authors.affiliation: Mater Mothers' Hospital, Brisbane, Australia. Peter.Gray@mater.org.au.
authors.forename: Peter
authors.initials: P
authors.lastname: Gray
authors.affiliation: Mater Mothers' Hospital, Brisbane, Australia. mocalla1@bigpond.net.au.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: O'Callaghan
authors.affiliation: Early Cognitive Development Centre, The School of Psychology, Faculty of Social and Behavioural Sciences, The University of Queensland, Brisbane, Australia. vps@psy.uq.edu.au.
authors.forename: Virginia
authors.initials: V
authors.lastname: Slaughter
authors.affiliation: Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, Faculty of Health Sciences, The University of Queensland, Brisbane, Australia. koawhittingham@uq.edu.au.|The School of Psychology, The University of Queensland, Faculty of Social and Behavioural Sciences, The University of Queensland, Brisbane, Australia. koawhittingham@uq.edu.au.
authors.forename: Koa
authors.initials: K
authors.lastname: Whittingham
authors.affiliation: QIMR Berghofer Medical Research Institute, Brisbane, Australia. Peter.ORourke@qimr.edu.au.
authors.forename: Peter
authors.initials: P
authors.lastname: O'Rourke
authors.affiliation: The University of Queensland Centre for Clinical Research, Faculty of Health Sciences, The University of Queensland, Royal Brisbane and Women's Hospital, Brisbane, Australia. l.winter@uq.edu.au.|The Parenting and Family Support Centre, School of Psychology, Faculty of Social and Behavioural Sciences, The University of Queensland, Brisbane, Australia. l.winter@uq.edu.au.
authors.forename: Leanne
authors.initials: L
authors.lastname: Winter
authors.affiliation: Royal Brisbane and Women's Hospital, Brisbane, Australia. t.evans3@uq.edu.au.|The School of Psychology, The University of Queensland, Faculty of Social and Behavioural Sciences, The University of Queensland, Brisbane, Australia. t.evans3@uq.edu.au.
authors.forename: Tracey
authors.initials: T
authors.lastname: Evans
authors.affiliation: Royal Brisbane and Women's Hospital, Brisbane, Australia. m.herd@uq.edu.au.|The School of Psychology, The University of Queensland, Faculty of Social and Behavioural Sciences, The University of Queensland, Brisbane, Australia. m.herd@uq.edu.au.
authors.forename: Michael
authors.initials: M
authors.lastname: Herd
authors.affiliation: Royal Brisbane and Women's Hospital, Brisbane, Australia. j.ahern@psy.uq.edu.au.|The School of Psychology, The University of Queensland, Faculty of Social and Behavioural Sciences, The University of Queensland, Brisbane, Australia. j.ahern@psy.uq.edu.au.
authors.forename: Jessica
authors.initials: J
authors.lastname: Ahern
authors.affiliation: Mater Mothers' Hospital, Brisbane, Australia. Luke.Jardine@mater.org.au.|The School of Psychology, The University of Queensland, Faculty of Social and Behavioural Sciences, The University of Queensland, Brisbane, Australia. Luke.Jardine@mater.org.au.
authors.forename: Luke
authors.initials: L
authors.lastname: Jardine
mesh_terms: D000223:Adaptation, Psychological; D002657:Child Development; D002675:Child, Preschool; D018479:Early Intervention, Educational; D006801:Humans; D007223:Infant; D018730:Infant Behavior; D007234:Infant, Premature; D009034:Mother-Child Relations / Q000523:psychology; D016487:Parenting / Q000523:psychology*; D010290:Parents / Q000193:education* / Q000523:psychology