title: An evaluation of the parents under pressure programme: a study protocol for an RCT into its clinical and cost effectiveness.
abstract: BACKGROUND
  Many babies in the UK are born to drug-dependent parents, and dependence on psychoactive drugs during the postnatal period is associated with high rates of child maltreatment, with around a quarter of these children being subject to a child protection plan. Parents who are dependent on psychoactive drugs are at risk of a wide range of parenting problems, and studies have found reduced sensitivity and responsiveness to both the infant's physical and emotional needs. The poor outcomes that are associated with such drug dependency appear to be linked to the multiple difficulties experienced by such parents.An increase in understanding about the crucial importance of early relationships for infant well-being has led to a focus on the development and delivery of services that are aimed at supporting parenting and parent-infant interactions. The Parents under Pressure (PuP) programme is aimed at supporting parents who are dependent on psychoactive drugs or alcohol by providing them with methods of managing their emotional regulation, and of supporting their new baby's development. An evaluation of the PuP programme in Australia with parents on methadone maintenance of children aged 3 to 8 years found significant reductions in child abuse potential, rigid parenting attitudes and child behaviour problems.
  
  
  METHODS
  The study comprises a multicentre randomised controlled trial using a mixed-methods approach to data collection and analysis in order to identify which families are most able to benefit from this intervention.The study is being conducted in six family centres across the UK, and targets primary caregivers of children less than 2.5 years of age who are substance dependent. Consenting participants are randomly allocated to either the 20-week PuP programme or to standard care.The primary outcome is child abuse potential, and secondary outcomes include substance use, parental mental health and emotional regulation, parenting stress, and infant/toddler socio-emotional adjustment scale.
  
  
  CONCLUSIONS
  This is one the first UK studies to examine the effectiveness of a programme targeting the parenting of substance-dependent parents of infants and toddlers, in terms of its effectiveness in improving the parent-infant relationship and reducing the potential for child abuse.
  
  
  BACKGROUND
  International Standard Randomised Controlled Trial Number Register: ISRCTN47282925.
authors.affiliation: Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry, UK. jane.barlow@warwick.ac.uk
authors.forename: Jane
authors.initials: J
authors.lastname: Barlow
authors.forename: Sukhdev
authors.initials: S
authors.lastname: Sembi
authors.forename: Frances
authors.initials: F
authors.lastname: Gardner
authors.forename: Geraldine
authors.initials: G
authors.lastname: Macdonald
authors.forename: Stavros
authors.initials: S
authors.lastname: Petrou
authors.forename: Helen
authors.initials: H
authors.lastname: Parsons
authors.forename: Paul
authors.initials: P
authors.lastname: Harnett
authors.forename: Sharon
authors.initials: S
authors.lastname: Dawe
mesh_terms: D000223:Adaptation, Psychological; D057229:Alcoholics / Q000523:psychology*; D000437:Alcoholism / Q000150:complications / Q000523:psychology; D002649:Child Abuse / Q000191:economics / Q000517:prevention & control* / Q000523:psychology; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D055030:Drug Users / Q000523:psychology*; D004644:Emotions; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007223:Infant; D008297:Male; D008603:Mental Health; D008605:Mental Health Services / Q000191:economics; D010287:Parent-Child Relations; D016487:Parenting / Q000523:psychology*; D016730:Program Development; D015397:Program Evaluation; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D013315:Stress, Psychological / Q000175:diagnosis / Q000191:economics / Q000209:etiology / Q000628:therapy*; D019966:Substance-Related Disorders / Q000150:complications / Q000191:economics / Q000523:psychology / Q000534:rehabilitation*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D006113:United Kingdom