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

Depression Clinical Trial

— FamilyTalkCL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02593266
• Other study ID #: FONDECYT-11130615
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2015
• Last updated: November 18, 2015
• Start date: November 2013
• Est. completion date: October 2016

Study information

• Verified date: November 2015
• Source: University of Chile
• Contact: Fernanda Prieto, CPsy
• Phone: +56963335055
• Email: fernandaprieto[@]gmail.com
• Is FDA regulated: No
• Health authority: Chile: Facultad de Medicina Universidad de Chile
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Patients who are currently undergoing a depressive episode or have done so in the past 3 months.

Exclusion Criteria:

For parents:

• 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.

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

Intervention

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

Locations

Country	Name	City	State
Chile	Clinica psiquiatrica Universitaria	Santiago de Chile

Sponsors (4)

Lead Sponsor	Collaborator
University of Chile	Children's Hospital Boston, Harvard Medical School, Wellesley College

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acceptability	The acceptability of the intervention will be evaluated through qualitative questionnaires.	7 weeks	No
Primary	feasibility	Feasibility will be assessed by looking at the number of families succesfully completing the study.	7 weeks	No
Secondary	Depressive symptoms in children	scores on the depression scale CDI	11 months	No
Secondary	Depressive symptoms in parents	scores on the depression scale BDI	11 months	No
Secondary	Family functioning	scores on the FACES-II scale	11 months	No
Secondary	Parental competence	scores on the E2P scale	11 months	No
Secondary	Adaptive behaviour in children	scores on the CBCL scale	11 months	No
Secondary	resilience in children	scores on the ERE scale	11 months	No

External Links

•   Collaborator's website
•   Project website