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

Primary Purpose

Maternal Depression, Parenting Behavior, Health

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy for Depression -Group
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maternal Depression focused on measuring Maternal Depression, Interpersonal Psychotherapy, School Readiness

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Institute, Inc.
  • University of Southern California School of Social Work

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Intervention

Control

comparison

Arm Description

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

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

Subjects screen negative for depression: no referral or intervention.

Outcomes

Primary Outcome Measures

Beck Depression Inventory

Secondary Outcome Measures

Full Information

First Posted
May 19, 2014
Last Updated
June 7, 2019
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT02145273
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Depression, Parenting Behavior, Health, Interpersonal Relationships, Goal Directed Behavior, Child Behavior, Child School Readiness
Keywords
Maternal Depression, Interpersonal Psychotherapy, School Readiness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Subjects screen positive for depression and are offered a group Therapy intervention for depression: Interpersonal Psychotherapy for Depression Group.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects screen positive for depression and are offered Treatment as usual: External referral.
Arm Title
comparison
Arm Type
No Intervention
Arm Description
Subjects screen negative for depression: no referral or intervention.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy for Depression -Group
Primary Outcome Measure Information:
Title
Beck Depression Inventory
Time Frame
At entry, completion of intervention, and every 6 months for 2 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Children's Institute, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90026
Country
United States
Facility Name
University of Southern California School of Social Work
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

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

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