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

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ClinicalTrials.gov Identifier: NCT02593266
Recruitment Status : Unknown
Verified November 2015 by Matias Irarrazaval, University of Chile.
Recruitment status was:  Recruiting
First Posted : November 2, 2015
Last Update Posted : November 20, 2015
Sponsor:
Collaborators:
Harvard Medical School
Boston Children’s Hospital
Wellesley College
Information provided by (Responsible Party):
Matias Irarrazaval, University of Chile

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).


Condition or disease Intervention/treatment Phase
Depression Behavioral: Preventive Intervention Program (PIP) for depression Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pilot Randomized Controlled Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents
Study Start Date : November 2013
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. acceptability [ Time Frame: 7 weeks ]
    The acceptability of the intervention will be evaluated through qualitative questionnaires.

  2. feasibility [ Time Frame: 7 weeks ]
    Feasibility will be assessed by looking at the number of families succesfully completing the study.


Secondary Outcome Measures :
  1. Depressive symptoms in children [ Time Frame: 11 months ]
    scores on the depression scale CDI

  2. Depressive symptoms in parents [ Time Frame: 11 months ]
    scores on the depression scale BDI

  3. Family functioning [ Time Frame: 11 months ]
    scores on the FACES-II scale

  4. Parental competence [ Time Frame: 11 months ]
    scores on the E2P scale

  5. Adaptive behaviour in children [ Time Frame: 11 months ]
    scores on the CBCL scale

  6. resilience in children [ Time Frame: 11 months ]
    scores on the ERE scale



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593266


Contacts
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Contact: Fernanda Prieto, CPsy +56963335055 fernandaprieto@gmail.com
Contact: Valeria de Angel, MSc +56957159311 valeriadeangel@gmail.com

Locations
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Chile
Clinica psiquiatrica Universitaria Recruiting
Santiago de Chile, Chile
Contact: Fernanda Prieto, CPsy    +56963335055    fernandaprieto@gmail.com   
Sponsors and Collaborators
University of Chile
Harvard Medical School
Boston Children’s Hospital
Wellesley College
Investigators
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Principal Investigator: Matias Irarrazaval, PhD University of Chile

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matias Irarrazaval, Dr. Matias Irarrazaval MD MPH, University of Chile
ClinicalTrials.gov Identifier: NCT02593266     History of Changes
Other Study ID Numbers: FONDECYT-11130615
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Keywords provided by Matias Irarrazaval, University of Chile:
Prevention
Family
Intervention
Depression
Children

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms