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A Clinic-based Prevention Program for Families of Depressed Mothers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00149812
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : August 5, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess the effectiveness of the "Keeping Families Strong" program (KFS) in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers.

Condition or disease Intervention/treatment Phase
Depression Attention Deficit Disorder With Hyperactivity Conduct Disorder Behavioral: Family Functioning Intervention Phase 1

Detailed Description:

Children of depressed mothers are at high risk for developing serious psychiatric disorders. While genetics can account for about 34% of cases of childhood psychiatric disorders, children of depressed parents are at an even greater risk of developing mental disorders. The "Keeping Families Strong" program, or KFS, was built from evidence-based prevention programs. Its goal is to provide educational, cognitive, and behavioral interventions. These interventions are meant to enhance understanding about depression and its effects on families, improve communication within families, enhance social support, increase positive and consistent parenting, and improve child coping. This will likely improve the children's mental health, as well as positively affect the short- and long-term outcomes of parents recovering from a depressive episode. This study will evaluate the effectiveness of the KFS program in avoiding or delaying the onset of psychiatric disorders among children with depressed mothers.

This 10-week, open-label program will involve 12 meetings, lasting 2 hours each. The parents and the children will attend separate meetings each week on the same nights. Children are prone to take on their parents' responsibilities to prevent them from becoming depressed. In order to avoid this, the children's meetings will focus on clarifying role responsibilities. There will be two additional follow-up meetings in the 3 months following completion of the program. All caregivers are encouraged to participate, including depressed fathers.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Clinic-based Program for Families of Depressed Mothers
Study Start Date : January 2005
Primary Completion Date : June 2008
Study Completion Date : December 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention
Intervention: "Keeping Families Strong" Cognitive Behavioral and Communication intervention with mothers recovering from depression and their children, 9 years and older.
Behavioral: Family Functioning Intervention

Outcome Measures

Primary Outcome Measures :
  1. Acceptability of program to parents, children, clinicians, and administrators throughout 10 weeks [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Improvement in the understanding of depression, family communication, parenting practices, and child coping over a one-year period [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Parent in treatment for depression
  • Parent in maintenance phase of treatment

Exclusion Criteria:

  • Active substance abuse
  • Substantial cognitive impairment
  • Psychosis
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149812

United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute of Mental Health (NIMH)
Principal Investigator: Anne W. Riley, PhD Bloomberg School of Public Health, Johns Hopkins University
More Information

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00149812     History of Changes
Other Study ID Numbers: R21MH067861 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Child disruptive behavior
Family functioning

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Conduct Disorder
Pathologic Processes
Behavioral Symptoms
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders