Clinical trial NCT02593266: A Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents
Official title: A Pilot Randomized Controlled Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Prevention
Family
Intervention
Depression
Children
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Boston Children's Hospital
name: Wellesley College
First posted: 2015-11-01
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: acceptability
timeFrame: 7 weeks
measure: feasibility
timeFrame: 7 weeks
Secondary outcomes:
measure: Depressive symptoms in children
timeFrame: 11 months
measure: Depressive symptoms in parents
timeFrame: 11 months
measure: Family functioning
timeFrame: 11 months
measure: Parental competence
timeFrame: 11 months
measure: Adaptive behaviour in children
timeFrame: 11 months
measure: resilience in children
timeFrame: 11 months
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Clinica psiquiatrica Universitaria
Study officials:
affiliation: University of Chile
name: Matias Irarrazaval, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Angel V, Prieto F, Gladstone TR, Beardslee WR, Irarrazaval M. The feasibility and acceptability of a preventive intervention programme for children with depressed parents: study protocol for a randomised controlled trial. Trials. 2016 May 6;17(1):237. doi: 10.1186/s13063-016-1348-7.