title: The feasibility and acceptability of a preventive intervention programme for children with depressed parents: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  One of the most important risk factors for childhood depression is being the child of a depressed parent. These at-risk children have two to four times the probability of having an affective episode compared with their peers. Preventive interventions such as Beardslee's Preventive Intervention Program (PIP) that are targeted at children of depressed parents have proven effective in many countries. The PIP is a family-based approach that works by promoting resilience in children and increasing positive interactions within the family. In this pilot randomised controlled trial (RCT), we will determine the acceptability and feasibility of an adapted version of this intervention in Chile.
  
  
  METHODS
  We are conducting a pilot RCT with a manualized intervention. The intervention will be delivered in seven weekly sessions at the family home. It is targeted mostly at parents but will also measure outcomes among the children. Control subjects will follow their treatment as usual. Feasibility and acceptability will be assessed by recruitment, adherence, dropout and level of missing data, as well as the burden of scales and measurement tools. Families will be followed for 11 months.
  
  
  CONCLUSIONS
  Given the negative lifelong consequences of depression and the burden they represent, preventive programmes are not only feasible but necessary. Despite the successful implementation of this intervention in different countries, an adaptation to the Chilean reality will be prerequisite. The results of this pilot study will inform a definitive trial that will make the case for its national implementation.
  
  
  BACKGROUND
  Clinicaltrials.gov trial identifier: NCT02593266 . Registration date: 30 Octo 2015.
authors.affiliation: Department of Psychiatry, Hospital Clínico University of Chile Medical School, Avenida La Paz, Recoleta, Santiago, 1003, Chile.
authors.forename: Valeria
authors.initials: V
authors.lastname: de Angel
authors.affiliation: Department of Psychiatry, Hospital Clínico University of Chile Medical School, Avenida La Paz, Recoleta, Santiago, 1003, Chile.|Millennium Institute for Research in Depression and Personality, Avda. Vicuña Mackenna, Macul, Santiago, 1003, Chile.
authors.forename: Fernanda
authors.initials: F
authors.lastname: Prieto
authors.affiliation: Wellesley College, 106 Central Street, Wellesley, MA, 02481-8203, USA.
authors.forename: Tracy R G
authors.initials: TR
authors.lastname: Gladstone
authors.affiliation: Department of Psychiatry, Baer Prevention Initiatives, Boston Children's Hospital, 300 Longwood Avenue, Boston, MA, 02115, USA.
authors.forename: William R
authors.initials: WR
authors.lastname: Beardslee
authors.affiliation: Department of Psychiatry, Hospital Clínico University of Chile Medical School, Avenida La Paz, Recoleta, Santiago, 1003, Chile. mirarrazavald@u.uchile.cl.|Millennium Institute for Research in Depression and Personality, Avda. Vicuña Mackenna, Macul, Santiago, 1003, Chile. mirarrazavald@u.uchile.cl.
authors.forename: Matías
authors.initials: M
authors.lastname: Irarrázaval
mesh_terms: D000223:Adaptation, Psychological; D002648:Child; D002652:Child Behavior; D016241:Child of Impaired Parents; D002677:Chile; D002985:Clinical Protocols; D003863:Depression / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D005196:Family Therapy / Q000379:methods*; D005240:Feasibility Studies; D006801:Humans; D009483:Neuropsychological Tests; D010287:Parent-Child Relations; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D055500:Resilience, Psychological; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
keywords: Acceptability; Adaptation; Children; Depressive disorder; Family-based; Feasibility; Parental depression; Pilot; Prevention; Protocol