A Clinic-based Prevention Program for Families of Depressed Mothers

NCT ID: NCT00149812

Last Updated: 2016-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2008-12-31

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.

Conditions

Depression; Attention Deficit Disorder With Hyperactivity; Conduct Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Intervention: "Keeping Families Strong" Cognitive Behavioral and Communication intervention with mothers recovering from depression and their children, 9 years and older.

Group Type: EXPERIMENTAL

Family Functioning Intervention

Intervention Type: BEHAVIORAL

Interventions

Family Functioning Intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Active substance abuse
• Substantial cognitive impairment
• Psychosis

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne W. Riley, PhD

Role: PRINCIPAL_INVESTIGATOR

Bloomberg School of Public Health, Johns Hopkins University

Locations

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18360775 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23420650 (View on PubMed)

Other Identifiers

R21MH067861

Identifier Type: NIH

Identifier Source: secondary_id

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R21MH067861

Identifier Type: NIH

Identifier Source: org_study_id

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