A Clinic-based Prevention Program for Families of Depressed Mothers

Sponsor
Johns Hopkins Bloomberg School of Public Health (Other)
Overall Status
Completed
CT.gov ID
NCT00149812
Collaborator
National Institute of Mental Health (NIMH) (NIH)
26
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1
47
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Study Details

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
  • 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
Actual Enrollment :
26 participants
Allocation:
N/A
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 :
Jan 1, 2005
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Dec 1, 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 [10 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years and Older
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00149812
Other Study ID Numbers:
  • R21MH067861
  • R21MH067861
First Posted:
Sep 8, 2005
Last Update Posted:
Aug 5, 2016
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Johns Hopkins Bloomberg School of Public Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2016