NCT02593266

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

2.9 years

First QC Date

May 28, 2015

Last Update Submit

November 18, 2015

Conditions

Depression

Keywords

PreventionFamilyInterventionDepressionChildren

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Depressive symptoms in children

    11 months

  • Depressive symptoms in parents

    11 months

  • Family functioning

    11 months

  • Parental competence

    11 months

  • Adaptive behaviour in children

    11 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

weekly sessions of PIP for depression.

Behavioral: Preventive Intervention Program (PIP) for depression

Waiting list control group

NO INTERVENTION

This is treatment as usual.

Interventions

Preventive Intervention Program (PIP) for depressionBEHAVIORAL

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

Intervention Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients who are currently undergoing a depressive episode or have done so in the past 3 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica psiquiatrica Universitaria

Santiago, Chile

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27153835DERIVED

Related Links

MeSH Terms

Conditions

Depression

Interventions

PIP protein, human

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Matias Irarrazaval, PhD

    University of Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda Prieto, CPsy

CONTACT

+56963335055fernandaprieto@gmail.com

Valeria de Angel, MSc

CONTACT

+56957159311valeriadeangel@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Matias Irarrazaval MD MPH

Study Record Dates

First Submitted

May 28, 2015

First Posted

November 2, 2015

Study Start

November 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

CL(1)