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

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Preventive Intervention Program (PIP) for depression
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Prevention, Family, Intervention, Depression, Children

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinica psiquiatrica UniversitariaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Waiting list control group

Arm Description

weekly sessions of PIP for depression.

This is treatment as usual.

Outcomes

Primary Outcome Measures

acceptability
The acceptability of the intervention will be evaluated through qualitative questionnaires.
feasibility
Feasibility will be assessed by looking at the number of families succesfully completing the study.

Secondary Outcome Measures

Depressive symptoms in children
scores on the depression scale CDI
Depressive symptoms in parents
scores on the depression scale BDI
Family functioning
scores on the FACES-II scale
Parental competence
scores on the E2P scale
Adaptive behaviour in children
scores on the CBCL scale
resilience in children
scores on the ERE scale

Full Information

First Posted
May 28, 2015
Last Updated
November 18, 2015
Sponsor
University of Chile
Collaborators
Harvard Medical School (HMS and HSDM), Boston Children's Hospital, Wellesley College
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1. Study Identification

Unique Protocol Identification Number
NCT02593266
Brief Title
A Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents
Acronym
FamilyTalkCL
Official Title
A Pilot Randomized Controlled Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile
Collaborators
Harvard Medical School (HMS and HSDM), Boston Children's Hospital, Wellesley College

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Prevention, Family, Intervention, Depression, Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
weekly sessions of PIP for depression.
Arm Title
Waiting list control group
Arm Type
No Intervention
Arm Description
This is treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Preventive Intervention Program (PIP) for depression
Intervention Description
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
Primary Outcome Measure Information:
Title
acceptability
Description
The acceptability of the intervention will be evaluated through qualitative questionnaires.
Time Frame
7 weeks
Title
feasibility
Description
Feasibility will be assessed by looking at the number of families succesfully completing the study.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Depressive symptoms in children
Description
scores on the depression scale CDI
Time Frame
11 months
Title
Depressive symptoms in parents
Description
scores on the depression scale BDI
Time Frame
11 months
Title
Family functioning
Description
scores on the FACES-II scale
Time Frame
11 months
Title
Parental competence
Description
scores on the E2P scale
Time Frame
11 months
Title
Adaptive behaviour in children
Description
scores on the CBCL scale
Time Frame
11 months
Title
resilience in children
Description
scores on the ERE scale
Time Frame
11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernanda Prieto, CPsy
Phone
+56963335055
Email
fernandaprieto@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Valeria de Angel, MSc
Phone
+56957159311
Email
valeriadeangel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matias Irarrazaval, PhD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica psiquiatrica Universitaria
City
Santiago de Chile
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernanda Prieto, CPsy
Phone
+56963335055
Email
fernandaprieto@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
27153835
Citation
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.
Results Reference
derived
Links:
URL
http://www.fampod.org
Description
Collaborator's website

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

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