Effect of Family-Based Prevention on Children of Depressed Parents

Study Overview
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Brief Summary
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This study will test the Protecting Families Program, a 10-week prevention program for depressed parents and their pre-teenage children, by comparing the effectiveness of the program versus parent training alone.

Detailed Description
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Children of depressed parents are at risk for developing social-emotional problems. Despite the fact that economic hardship is a strong risk factor for both maternal depression and poor child development, little research has been conducted to develop prevention programs for low-income urban families. This randomized, open-label study will address the research gap by developing and pilot-testing the Protecting Families Program (PFP), a family-based, multi-component prevention program. The PFP will offer its services to low-income, urban, depressed parents and their children between the ages of 9 and 14. Prior to the interventional portion of the study, several small focus groups composed of mental-health care providers and depressed parents will meet. The purpose of these focus groups will be to gather information that will help maximize the effectiveness of the remainder of the study. The interventional phase will compare PFP combined with individual parent training versus parent training alone. Participants will be randomly assigned to one of these two intervention groups. The study will last a total of 10 weeks. Both groups will meet once each week. PFP will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (CBT) group for the focal child. Participants' symptoms, diagnosis, functional status, family functioning, cognitive factors, and parenting practices will be assessed at the study start date, immediately post-intervention, and 6 months post-intervention.

Official Title
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Children of Depressed Parents: Family-Based Prevention

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Parent Skills Training
* Behavioral: Protecting Families Program (PFP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent is currently in treatment Parent's primary DSM-IV diagnosis is major depressive disorder, dysthymia, or depression not otherwise specified Parent's child lives with him/her at least part time Exclusion criteria: Parent has a history or current diagnosis of any psychotic disorder or organic brain syndrome Parent has history of bipolar or schizoaffective disorder Parent's IQ is below 70 Parent has any serious medical or neurological disorder or condition that may prevent weekly participation Parent has chronic pain that may prevent weekly participation Parent or child is currently suicidal to the extent that it will interfere with outpatient treatment Parent has a current substance dependence Child is currently seeking psychological treatment Child is mentally retarded (determined by school and clinic records) Child has a clinically severe psychiatric diagnosis

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: 1<br>Participants will receive the Protecting Families Program with individual parent training | Behavioral: Parent Skills Training<br>* Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.<br>Behavioral: Protecting Families Program (PFP)<br>* Participants will receive 10 weeks of PFP, which will include a community meal at the beginning of each session, a parent skills training group, and a concurrent cognitive behavioral therapy (CBT) group for the focal child.<br>|
| Active Comparator: 2<br>Participants will receive parent training alone | Behavioral: Parent Skills Training<br>* Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child psychiatric symptomology |  | Measured immediately post-treatment and at 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting skills, family functioning, and parent social support |  | Measured immediately post-treatment and at 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family, Parenting, Depression, Group Intervention