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01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Trials 1/2016

The feasibility and acceptability of a preventive intervention programme for children with depressed parents: study protocol for a randomised controlled trial

Zeitschrift:
Trials > Ausgabe 1/2016
Autoren:
Valeria de Angel, Fernanda Prieto, Tracy R. G. Gladstone, William R. Beardslee, Matías Irarrázaval
Wichtige Hinweise

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

VdA: drafting of a large portion of the manuscript and intellectual contribution to the design of the trial. FP: revision and editing of the manuscript, intellectual contribution to the design of the trial, recruitment coordination, adaptation of materials to the target population. TRGG: contributed to the implementation and evaluation of the original intervention, as well as editing and intellectual contribution to the writing of the manuscript. WRB: co-creator of the intervention and editing and intellectual contribution to the writing of the manuscript. MI: drafting of a portion of the manuscript as well as its editing and final approval, intellectual contribution to the design of the trial, and acquisition of funding. All authors read and approved the final manuscript.

Authors’ information

VdA: B.Sc.(Hons) in psychology at Goldsmith’s College, University of London; MSc in psychiatric research at King’s College, London. VdA currently works as a research assistant and methodological and statistical consultant at the University of Chile.
FP: child and adolescent clinical psychologist at the Catholic University of Chile. FP has a diploma in child and adolescent psychodiagnosis, also from the Catholic University of Chile, and currently works as a research assistant at the University of Chile in addition to attending to her private practice.
TRGG, Ph.D. in clinical psychology from Emory University, is an assistant in psychology at Boston Children’s Hospital, an instructor at Harvard Medical School, a research scientist at Judge Baker Children’s Centre, and the inaugural director of the Robert S. and Grace W. Stone Primary Prevention Initiatives at the Wellesley Centres for Women, Wellesley College. She is a co-principal investigator of two multi-site depression prevention trials targeting at-risk adolescents, principal investigator of a large-scale, school-based depression prevention study, and a member of the Baer Prevention Initiatives research team. In addition, she is a licensed clinical psychologist.
WRB: received his M.D. degree from Case Western Reserve University. He completed an internship at University of California Medical Center and a residency and fellowship at Children’s Hospital Boston. Author of over 225 articles and chapters and two books, ’his research focuses on depression in children. He is principal investigator of a long-term study of parental depression, on the basis of which he identified risk factors for depression in children. He then went on to implement a prevention program for families in crisis. In the last several years, his research effort has been focused on helping other investigators use the approach, on treatment and preventive approaches for childhood depression and on international collaborations.
MI: child and adolescent psychiatrist at the University of Chile and assistant professor at the Las Condes Clinic and the University of Chile, received a ’master’s degree in public health and did a postdoctoral research fellowship at the Harvard Medical School and Judge Baker Children’s Center. MI is the principal investigator of a current government-funded project titled ‘A pilot randomised controlled trial of a preventative intervention program in depression for Chilean Families’.

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/design

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.

Discussion

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.

Trial registration

Clinicaltrials.gov trial identifier: NCT02593266. Registration date: 30 Octo 2015.
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