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

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

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).

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Behavioral: Preventive Intervention Program (PIP) for depression

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago de Chile, Chile
    • Recruiting
    • Clinica psiquiatrica Universitaria
    • Contact: Fernanda Prieto, CPsy; Phone Number: +56963335055; Email: fernandaprieto@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; weekly sessions of PIP for depression.	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
No Intervention: Waiting list control group; This is treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acceptability	The acceptability of the intervention will be evaluated through qualitative questionnaires.	7 weeks
feasibility	Feasibility will be assessed by looking at the number of families succesfully completing the study.	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms in children	scores on the depression scale CDI	11 months
Depressive symptoms in parents	scores on the depression scale BDI	11 months
Family functioning	scores on the FACES-II scale	11 months
Parental competence	scores on the E2P scale	11 months
Adaptive behaviour in children	scores on the CBCL scale	11 months
resilience in children	scores on the ERE scale	11 months

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: Harvard Medical School (HMS and HSDM); Boston Children's Hospital; Wellesley College
• Investigators: Principal Investigator: Matias Irarrazaval, PhD, University of Chile

Publications and helpful links

General Publications

• 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.

Helpful Links

• Collaborator's website

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): October 1, 2016

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 18, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Depression; Family; Children; Prevention; Intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: FONDECYT-11130615