A Clinic-based Prevention Program for Families of Depressed Mothers
Primary Purpose
Depression, Attention Deficit Disorder With Hyperactivity, Conduct Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Family Functioning Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Depression, Child disruptive behavior, Family functioning
Eligibility Criteria
Inclusion Criteria: Parent in treatment for depression Parent in maintenance phase of treatment Exclusion Criteria: Active substance abuse Substantial cognitive impairment Psychosis
Sites / Locations
- Johns Hopkins Bloomberg School of Public Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Intervention: "Keeping Families Strong" Cognitive Behavioral and Communication intervention with mothers recovering from depression and their children, 9 years and older.
Outcomes
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
Full Information
NCT ID
NCT00149812
First Posted
September 6, 2005
Last Updated
August 3, 2016
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00149812
Brief Title
A Clinic-based Prevention Program for Families of Depressed Mothers
Official Title
A Clinic-based Program for Families of Depressed Mothers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Attention Deficit Disorder With Hyperactivity, Conduct Disorder
Keywords
Depression, Child disruptive behavior, Family functioning
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention: "Keeping Families Strong" Cognitive Behavioral and Communication intervention with mothers recovering from depression and their children, 9 years and older.
Intervention Type
Behavioral
Intervention Name(s)
Family Functioning Intervention
Primary Outcome Measure Information:
Title
Acceptability of program to parents, children, clinicians, and administrators throughout 10 weeks
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Improvement in the understanding of depression, family communication, parenting practices, and child coping over a one-year period
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parent in treatment for depression
Parent in maintenance phase of treatment
Exclusion Criteria:
Active substance abuse
Substantial cognitive impairment
Psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne W. Riley, PhD
Organizational Affiliation
Bloomberg School of Public Health, Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bloomberg School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18360775
Citation
Riley AW, Valdez CR, Barrueco S, Mills C, Beardslee W, Sandler I, Rawal P. Development of a family-based program to reduce risk and promote resilience among families affected by maternal depression: theoretical basis and program description. Clin Child Fam Psychol Rev. 2008 Jun;11(1-2):12-29. doi: 10.1007/s10567-008-0030-3.
Results Reference
background
PubMed Identifier
23420650
Citation
Valdez CR, Mills CL, Barrueco S, Leis J, Riley AW. A Pilot Study of a Family-Focused Intervention for Children and Families Affected by Maternal Depression. J Fam Ther. 2011 Feb;33(1):3-19. doi: 10.1111/j.1467-6427.2010.00529.x.
Results Reference
background
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A Clinic-based Prevention Program for Families of Depressed Mothers
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