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
  Purpose
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
Depression
Attention Deficit Disorder With Hyperactivity
Conduct Disorder
Behavioral: Family Functioning Intervention
Phase 1

Study Type: Interventional
Study Design: 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 Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Acceptability of program to parents, children, clinicians, and administrators throughout 10 weeks [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Locations
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)
Investigators
Principal Investigator: Anne W. Riley, PhD Bloomberg School of Public Health, Johns Hopkins University
  More Information

Publications:
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00149812     History of Changes
Other Study ID Numbers: R21MH067861 
Study First Received: September 6, 2005
Last Updated: August 3, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on August 30, 2016