Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children

Child Behavior Clinical Trial

Official title:

Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145273
• Other study ID #: 90YR0074-01-00
• Secondary ID: 90YR0074-01
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2018

Study information

• Verified date: April 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior
• Child School Readiness
• Depression
• Depressive Disorder
• Goal Directed Behavior
• Health
• Interpersonal Relationships
• Maternal Depression
• Parenting Behavior

Intervention

Behavioral:
• Interpersonal Psychotherapy for Depression -Group

Locations

Country	Name	City	State
United States	Children's Institute, Inc.	Los Angeles	California
United States	University of Southern California School of Social Work	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory		At entry, completion of intervention, and every 6 months for 2 years