DepressionFamilyTalkCLNCT02593266
A Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents
A study testing Preventive Intervention Program (PIP) for depression in people with Depression, run by University of Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Preventive Intervention Program (PIP) for depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChile
- Study dates
- Nov 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who are currently undergoing a depressive episode or have done so in the past 3 months.
Who cannot join
- 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:
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Clinica psiquiatrica Universitaria
Santiago
Fernanda Prieto, CPsy, +56963335055, fernandaprieto@gmail.com
About this study
Official title: A Pilot Randomized Controlled Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents
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).
Read the 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.
- Conditions
- Depression
- Being tested
- Preventive Intervention Program (PIP) for depression
- Keywords
- Prevention, Family, Intervention, Depression, Children
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive Intervention Program (PIP) for depressionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | weekly sessions of PIP for depression. Receives: Behavioral: Preventive Intervention Program (PIP) for depression |
| Waiting list control group | No intervention | This is treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptability
The acceptability of the intervention will be evaluated through qualitative questionnaires.
Measured: 7 weeks
feasibility
Feasibility will be assessed by looking at the number of families succesfully completing the study.
Measured: 7 weeks
Secondary outcomes (6)
Depressive symptoms in children
scores on the depression scale CDI
Measured: 11 months
Depressive symptoms in parents
scores on the depression scale BDI
Measured: 11 months
Family functioning
scores on the FACES-II scale
Measured: 11 months
Parental competence
scores on the E2P scale
Measured: 11 months
Adaptive behaviour in children
scores on the CBCL scale
Measured: 11 months
resilience in children
scores on the ERE scale
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startNov 2013
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Boston Children's Hospital, Wellesley College
- Responsible party
- Principal investigator, Matias Irarrazaval, University of Chile
- Investigators
- Matias Irarrazaval, PhD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593266
- Sponsor's protocol ID
- FONDECYT-11130615
- Acronym
- FamilyTalkCL
- Status last verified
- Nov 2015
- First submitted
- 28 May 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27153835
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents
- ClinicalTrials.gov ID
- NCT02593266
- Acronym / sponsor ID
- FamilyTalkCL / FONDECYT-11130615
- Conditions
- Depression
- Keywords
- Prevention, Family, Intervention, Depression, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Boston Children's Hospital, Wellesley College
- Study start
- Nov 2013
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Preventive Intervention Program (PIP) for depressionweekly sessions of PIP for depression. |
| Waiting list control group | No intervention | –This is treatment as usual. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients who are currently undergoing a depressive episode or have done so in the past 3 months.
Key exclusion criteria (10 listed)
- 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.
- Being outside the age range of 6-12 years at the time of recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventive Intervention Program (PIP) for depressionManualized 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 | Behavioural | Intervention Group |
Primary outcome
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.
6 secondary outcomes
Depressive symptoms in children
Time frame: 11 months
Depressive symptoms in parents
Time frame: 11 months
Family functioning
Time frame: 11 months
Parental competence
Time frame: 11 months
Adaptive behaviour in children
Time frame: 11 months
resilience in children
Time frame: 11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 27153835de 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.
- Collaborator's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matias Irarrazaval, PhD principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive Intervention Program (PIP) for depression in people with Depression, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda Prieto, CPsy (+56963335055, fernandaprieto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acceptability (time frame: 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02593266, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.