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

This study is currently recruiting participants.
Verified April 2017 by Ferol Mennen, University of Southern California
Sponsor:
ClinicalTrials.gov Identifier:
NCT02145273
First Posted: May 22, 2014
Last Update Posted: April 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ferol Mennen, University of Southern California
  Purpose
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.

Condition Intervention
Maternal Depression Parenting Behavior Health Interpersonal Relationships Goal Directed Behavior Child Behavior Child School Readiness Behavioral: Interpersonal Psychotherapy for Depression -Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Healthy Moms-Healthy Kids: Reducing Maternal Depression for Better Outcomes in Head Start Children

Further study details as provided by Ferol Mennen, University of Southern California:

Primary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: At entry, completion of intervention, and every 6 months for 2 years ]

Estimated Enrollment: 180
Study Start Date: September 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Subjects screen positive for depression and are offered a group Therapy intervention for depression: Interpersonal Psychotherapy for Depression Group.
Behavioral: Interpersonal Psychotherapy for Depression -Group
No Intervention: Control
Subjects screen positive for depression and are offered Treatment as usual: External referral.
No Intervention: comparison
Subjects screen negative for depression: no referral or intervention.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145273


Contacts
Contact: Ferol E Mennen, PhD, MSW 213-740-0295 mennen@usc.edu
Contact: William L Monro, MSW 213-821-3643 wmonro@usc.edu

Locations
United States, California
Children's Institute, Inc. Recruiting
Los Angeles, California, United States, 90026
Contact: Manuel Rivera, PhD    213-260-7600    mrivera@ChildrensInstitute.org   
Principal Investigator: Manuel Rivera, PhD         
University of Southern California School of Social Work Recruiting
Los Angeles, California, United States, 90089
Contact: Ferol Mennen, PhD    213-740-0295    mennen@usc.edu   
Principal Investigator: Ferol E Mennen, PhD, MSW         
Sponsors and Collaborators
University of Southern California
  More Information

Responsible Party: Ferol Mennen, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02145273     History of Changes
Other Study ID Numbers: 90YR0074-01-00
90YR0074-01 ( U.S. NIH Grant/Contract )
First Submitted: May 19, 2014
First Posted: May 22, 2014
Last Update Posted: April 19, 2017
Last Verified: April 2017

Keywords provided by Ferol Mennen, University of Southern California:
Maternal Depression
Interpersonal Psychotherapy
School Readiness

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders