A Clinic-Based Prevention Program for Families of Depressed Mothers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
First received: September 6, 2005
Last updated: October 29, 2007
Last verified: September 2005
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 Intervention Phase
Attention Deficit Disorder With Hyperactivity
Conduct Disorder
Behavioral: Family Functioning Intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Clinic-Based Program for Families of Depressed Mothers

Resource links provided by NLM:

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Acceptability of program to parents, children, clinicians, and administrators throughout 10 weeks

Secondary Outcome Measures:
  • Improvement in the understanding of depression, family communication, parenting practices, and child coping over a one-year period

Estimated Enrollment: 40
Study Start Date: January 2005
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.


Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149812

Contact: Anne W. Riley, PhD ariley@jhsph.edu
Contact: Carmen Valdez, PhD cvaldez@jhsph.edu

United States, Maryland
Johns Hopkins Bloomberg School of Public Health Recruiting
Baltimore, Maryland, United States, 21205
Contact: Anne W. Riley, PhD    410-955-2371    ariley@jhsph.edu   
Contact: Carmen Valdez, PhD    410-955-2371    cvaldez@jhsph.edu   
Principal Investigator: Anne W. Riley, PhD, BSN         
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Principal Investigator: Anne W. Riley, PhD Bloomberg School of Public Health, Johns Hopkins University
  More Information

ClinicalTrials.gov Identifier: NCT00149812     History of Changes
Other Study ID Numbers: R21MH067861  DSIR 82-SECH 
Study First Received: September 6, 2005
Last Updated: October 29, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Child disruptive behavior
Family functioning

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

ClinicalTrials.gov processed this record on May 26, 2016