A Clinic-based Prevention Program for Families of Depressed Mothers

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00149812
First received: September 6, 2005
Last updated: August 3, 2016
Last verified: August 2016

September 6, 2005
August 3, 2016
January 2005
June 2008   (final data collection date for primary outcome measure)
Acceptability of program to parents, children, clinicians, and administrators throughout 10 weeks [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Acceptability of program to parents, children, clinicians, and administrators throughout 10 weeks
Complete list of historical versions of study NCT00149812 on ClinicalTrials.gov Archive Site
Improvement in the understanding of depression, family communication, parenting practices, and child coping over a one-year period [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Improvement in the understanding of depression, family communiation, parenting practices, and child coping over a one-year period
Not Provided
Not Provided
 
A Clinic-based Prevention Program for Families of Depressed Mothers
A Clinic-based Program for Families of Depressed Mothers
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.

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Depression
  • Attention Deficit Disorder With Hyperactivity
  • Conduct Disorder
Behavioral: Family Functioning Intervention
Experimental: Intervention
Intervention: "Keeping Families Strong" Cognitive Behavioral and Communication intervention with mothers recovering from depression and their children, 9 years and older.
Intervention: Behavioral: Family Functioning Intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Active substance abuse
  • Substantial cognitive impairment
  • Psychosis
Both
8 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00149812
R21MH067861, R21MH067861
No
No
Not Provided
Johns Hopkins Bloomberg School of Public Health
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
Johns Hopkins Bloomberg School of Public Health
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP