A Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents
NCT ID: NCT02593266
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
64 participants
INTERVENTIONAL
2013-11-30
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The PIP is a family intervention directed towards strengthening family functioning and enhancing resilience in children of depressed parents. It comprises several modules that work on psycho-education and skill development within the family nucleus.
A single-blind randomized controlled trial will be conducted with two arms, the intervention arm (n=32) which will receive a home-based PIP for depression, and the TAU arm (n=32).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Objectives: To evaluate acceptability and feasibility of an adaptation of Beardslee's 'Preventive Intervention Program (PIP) for Depression' in Chilean families, and to measure the clinical effects of this intervention.
Participants: Parents with an episode of Depression in the past 3 months with at least one non-depressed child between the ages of 6-12.
Design: single-blind randomized controlled trial with two groups; the intervention group (n=32), which will receive a home-based PIP for depression, and the treatment-as-usual control group (n=32).
Results: Acceptability and feasibility will be measured by determining whether the trial was successfully conducted and well received by the families and preventionists. Recruitment and delivery of the intervention will be assessed as well as whether there was appropriate response and follow-up, and whether the objectives of the study were reached. Secondary outcomes will look at depressive symptoms, family function, psycho-education, parental competence, adaptive behavior and resilience in children.
Follow-up times: T = 0 baseline, T= 2 months (post-intervention), T=5 months, T=8 months, T=11 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Group
weekly sessions of PIP for depression.
Preventive Intervention Program (PIP) for depression
Manualized intervention designed by Beardslee and colleagues (Beardslee et al., 2003) It is a program based on cognitive behavioural therapy, narrative therapy and systemic therapy. It is divided in 7 modules which are imparted weekly in the family home by 2 'preventionists' (therapists trained to deliver the intervention)
* Module 1: Depression and family
* Module 2: Psychoeducation about depression
* Module 3:The child's perspective on their parent's depression
* Module 4: Skills development
* Module 5: Preparation for the family session
* Module 6: Family session
* Module 7: Revision and future planning
* Follow-up
Waiting list control group
This is treatment as usual.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Preventive Intervention Program (PIP) for depression
Manualized intervention designed by Beardslee and colleagues (Beardslee et al., 2003) It is a program based on cognitive behavioural therapy, narrative therapy and systemic therapy. It is divided in 7 modules which are imparted weekly in the family home by 2 'preventionists' (therapists trained to deliver the intervention)
* Module 1: Depression and family
* Module 2: Psychoeducation about depression
* Module 3:The child's perspective on their parent's depression
* Module 4: Skills development
* Module 5: Preparation for the family session
* Module 6: Family session
* Module 7: Revision and future planning
* Follow-up
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Alcohol or drug dependence or abuse as assessed by the MINI or being in treatment for substance use.
* Psychosis, personality disorder, bipolar disorder or suicide ideation as assessed by the MINI.
* Having a relationship crisis with current partner. Assessed by self-report or by having attended couple's therapy in the past month.
* Attending family therapy.
For children:
* Being outside the age range of 6-12 years at the time of recruitment.
* Intellectual disability
* Having depression as assessed by the MINI Kid
* Being in treatment for a psychiatric disorder or having taken psychotropic medication in the last month.
6 Years
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Chile
OTHER
Harvard Medical School (HMS and HSDM)
OTHER
Boston Children's Hospital
OTHER
Wellesley College
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Matias Irarrazaval
Dr. Matias Irarrazaval MD MPH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matias Irarrazaval, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Chile
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinica psiquiatrica Universitaria
Santiago, , Chile
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
de Angel V, Prieto F, Gladstone TR, Beardslee WR, Irarrazaval M. The feasibility and acceptability of a preventive intervention programme for children with depressed parents: study protocol for a randomised controlled trial. Trials. 2016 May 6;17(1):237. doi: 10.1186/s13063-016-1348-7.
Related Links
Access external resources that provide additional context or updates about the study.
Collaborator's website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FONDECYT-11130615
Identifier Type: -
Identifier Source: org_study_id