A Trial of a Preventive Intervention Program for Chilean Families With

Status Recruiting

Clinical Trial Summary

The overall aim of this pilot study is to evaluate the acceptability and feasibility of an adaptation of Beardslee's 'Preventive Intervention Program (PIP) for Depression' in Chilean families.

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).

Clinical Trial Description

Being a child with depressed parents is associated with poor health and academic outcomes as well as having four times the likelihood of developing a mood disorder compared to children of non-depressed parents.

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Depression

Clinical Trial Details

NCT number	NCT02593266
Study type	Interventional
Source	University of Chile
Contact	Fernanda Prieto, CPsy
Phone	+56963335055
Email	fernandaprieto@gmail.com
Status	Recruiting
Phase	N/A
Start date	November 2013
Completion date	October 2016

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents — FamilyTalkCL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms