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Effect of Family-Based Prevention on Children of Depressed Parents

Children of Depressed Parents: Family-Based Prevention

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00183365
Enrollment
42
Registered
2005-09-16
Start date
2005-10-31
Completion date
2009-11-30
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Family, Parenting, Depression, Group Intervention

Brief summary

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

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.

Interventions

Parent skills training will include 10 weeks of psychoeducational and skills training group sessions for parents.

BEHAVIORALProtecting Families Program (PFP)

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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Child psychiatric symptomologyMeasured immediately post-treatment and at 6-month follow-up

Secondary

MeasureTime frame
Parenting skills, family functioning, and parent social supportMeasured immediately post-treatment and at 6-month follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026