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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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)
No Intervention: Waiting list control group
This is treatment as usual.
- acceptability [ Time Frame: 7 weeks ]The acceptability of the intervention will be evaluated through qualitative questionnaires.
- feasibility [ Time Frame: 7 weeks ]Feasibility will be assessed by looking at the number of families succesfully completing the study.
- Depressive symptoms in children [ Time Frame: 11 months ]scores on the depression scale CDI
- Depressive symptoms in parents [ Time Frame: 11 months ]scores on the depression scale BDI
- Family functioning [ Time Frame: 11 months ]scores on the FACES-II scale
- Parental competence [ Time Frame: 11 months ]scores on the E2P scale
- Adaptive behaviour in children [ Time Frame: 11 months ]scores on the CBCL scale
- resilience in children [ Time Frame: 11 months ]scores on the ERE scale
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
|Contact: Fernanda Prieto, CPsyfirstname.lastname@example.org|
|Contact: Valeria de Angel, MScemail@example.com|
|Clinica psiquiatrica Universitaria||Recruiting|
|Santiago de Chile, Chile|
|Contact: Fernanda Prieto, CPsy +56963335055 firstname.lastname@example.org|
|Principal Investigator:||Matias Irarrazaval, PhD||University of Chile|