A Clinic-based Prevention Program for Families of Depressed Mothers

Depression Clinical Trial

Official title:

A Clinic-based Program for Families of Depressed Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149812
• Other study ID #: R21MH067861
• Secondary ID: R21MH067861
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2005
• Last updated: August 3, 2016
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: August 2016
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Parent in treatment for depression

• Parent in maintenance phase of treatment

Exclusion Criteria:

• Active substance abuse

• Substantial cognitive impairment

• Psychosis

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Conduct Disorder
• Depression
• Disease

Intervention

Behavioral:
• Family Functioning Intervention

Locations

Country	Name	City	State
United States	Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of program to parents, children, clinicians, and administrators throughout 10 weeks		10 weeks	No
Secondary	Improvement in the understanding of depression, family communication, parenting practices, and child coping over a one-year period		1 year	No