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

U

University of Chile

Status

Unknown

Conditions

Depression

Treatments

Behavioral: Preventive Intervention Program (PIP) for depression

Study type

Interventional

Funder types

Other

Identifiers

NCT02593266
FONDECYT-11130615

Details and patient eligibility

About

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).

Full 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.

Enrollment

64 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 2 patient groups

Intervention Group
Experimental group
Description:
weekly sessions of PIP for depression.
Treatment:
Behavioral: Preventive Intervention Program (PIP) for depression
Waiting list control group
No Intervention group
Description:
This is treatment as usual.

Trial contacts and locations

1

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Central trial contact

Valeria de Angel, MSc; Fernanda Prieto, CPsy

Data sourced from clinicaltrials.gov

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