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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Preventive Intervention Program (PIP) for depression


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>weekly sessions of PIP for depression. | Behavioral: Preventive Intervention Program (PIP) for depression<br>* 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<br>|
| No Intervention: Waiting list control group<br>This is treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acceptability | The acceptability of the intervention will be evaluated through qualitative questionnaires. | 7 weeks | 
| feasibility | Feasibility will be assessed by looking at the number of families succesfully completing the study. | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms in children | scores on the depression scale CDI | 11 months | 
| Depressive symptoms in parents | scores on the depression scale BDI | 11 months | 
| Family functioning | scores on the FACES-II scale | 11 months | 
| Parental competence | scores on the E2P scale | 11 months | 
| Adaptive behaviour in children | scores on the CBCL scale | 11 months | 
| resilience in children | scores on the ERE scale | 11 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Family, Intervention, Depression, Children