Clinical trial NCT02145273: Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children
Official title: Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Depression
Parenting Behavior
Health
Interpersonal Relationships
Goal Directed Behavior
Child Behavior
Child School Readiness
Keywords: Maternal Depression
Interpersonal Psychotherapy
School Readiness
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 208
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 3 conditions that will be followed for up to 2 years: control, intervention and comparison. Randomization is by site. Half the sites are control half are intervention. all possible subjects are screened for depression. if the subject is depressed they are invited in to control or intervention based on site, all non depressed subjects are invited into the comparison.
Primary purpose: TREATMENT

Brief summary: Maternal depression is a pervasive problem that disproportionately affects low-income mothers. The effects of depression on mothers and their parenting result in many negative outcomes for children, particularly in terms of school readiness. The proposed research will build on a successful partnership between the University of Southern California School of Social Work (USC) and Children's Institute, Inc. (CII) to implement and evaluate an evidence-based intervention, interpersonal psychotherapy for group (IPT-G), for Head Start mothers with depression or dysphoric mood with the goal of reducing their depression and promoting positive changes for both mothers and children. The objectives of the study are: (1) adapt IPT-G for a Head Start population of mothers with depression; (2) implement IPT-G via a randomized controlled trial in Head Start centers in Los Angeles County operated by CII; (3) evaluate the effects of the intervention on maternal depression, parenting behaviors, goal-directed behavior, interpersonal relationships, physical health, and child behavior and school readiness; and (4) develop a manual for use of the intervention in Head Start and disseminate findings nationally. The study will feature 2 groups of 60 mothers each, randomized by Head Start site; one will receive the intervention and the other services as usual. Outcomes for both mothers and children will be tracked for 2 years after the intervention, allowing for the evaluation of short- and long-term effects. The intervention will be delivered by Head Start mental health workers under the supervision of Scott Stuart, a national trainer of the intervention. This intervention has the potential to be a low-cost, high-impact intervention that can be replicated to other Head Start sites across the country to improve the lives of Head Start children and families.


Eligibility criteria: Inclusion Criteria:

* Mothers of children in Head Start with scores on screening measure that are in depressed or possibly depressed range to be assigned to intervention or TAU. Also will have additional control group of non depressed mothers

Exclusion Criteria:

* Not able to function in group environment

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: At entry, completion of intervention, and every 6 months for 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Institute, Inc.
state: California
city: Los Angeles
country: United States
facility: University of Southern California School of Social Work
state: California
Study officials:
References: