Clinical trial NCT00149812: A Clinic-based Prevention Program for Families of Depressed Mothers
Official title: A Clinic-based Program for Families of Depressed Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Attention Deficit Disorder With Hyperactivity
Conduct Disorder
Keywords: Depression
Child disruptive behavior
Family functioning
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-08
Enrollment: 26
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Active substance abuse
* Substantial cognitive impairment
* Psychosis

Primary outcomes:
measure: Acceptability of program to parents, children, clinicians, and administrators throughout 10 weeks
timeFrame: 10 weeks
Secondary outcomes:
measure: Improvement in the understanding of depression, family communication, parenting practices, and child coping over a one-year period
timeFrame: 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Bloomberg School of Public Health, Johns Hopkins University
name: Anne W. Riley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.