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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02593266
Acronym
FamilyTalkCL
Enrollment
64
Registered
2015-11-02
Start date
2013-11-30
Completion date
2016-10-31
Last updated
2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Prevention, Family, Intervention, Depression, Children

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.

Interventions

BEHAVIORALPreventive 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

Sponsors

Harvard Medical School (HMS and HSDM)
CollaboratorOTHER
Boston Children's Hospital
CollaboratorOTHER
Wellesley College
CollaboratorOTHER
University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
acceptability7 weeksThe acceptability of the intervention will be evaluated through qualitative questionnaires.
feasibility7 weeksFeasibility will be assessed by looking at the number of families succesfully completing the study.

Secondary

MeasureTime frameDescription
Family functioning11 monthsscores on the FACES-II scale
Parental competence11 monthsscores on the E2P scale
Depressive symptoms in children11 monthsscores on the depression scale CDI
resilience in children11 monthsscores on the ERE scale
Adaptive behaviour in children11 monthsscores on the CBCL scale
Depressive symptoms in parents11 monthsscores on the depression scale BDI

Countries

Chile

Contacts

Primary ContactFernanda Prieto, CPsy
fernandaprieto@gmail.com+56963335055
Backup ContactValeria de Angel, MSc
valeriadeangel@gmail.com+56957159311

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026