NCT02593266

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

A Pilot Randomized Controlled Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	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

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-11-02
• Last updated: 2015-11-20

Locations

1 site across 1 country: Chile