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Clinical Trials/NCT02145273
NCT02145273CompletedNot Applicable

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

University of Southern California4 sites in 1 country208 target enrollmentStarted: September 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
208
Locations
4
Primary Endpoint
Beck Depression Inventory

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention

Experimental

Subjects screen positive for depression and are offered a group Therapy intervention for depression: Interpersonal Psychotherapy for Depression Group.

Intervention: Interpersonal Psychotherapy for Depression -Group (Behavioral)

Control

No Intervention

Subjects screen positive for depression and are offered Treatment as usual: External referral.

comparison

No Intervention

Subjects screen negative for depression: no referral or intervention.

Outcomes

Primary Outcomes

Beck Depression Inventory

Time Frame: At entry, completion of intervention, and every 6 months for 2 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ferol Mennen

Associate Professor

University of Southern California

Study Sites (4)

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